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Community-based Intervention Effects on Older Adults' Physical Activity

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ClinicalTrials.gov Identifier: NCT03326141
Recruitment Status : Completed
First Posted : October 31, 2017
Results First Posted : April 24, 2024
Last Update Posted : April 24, 2024
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Exercise
Physical Activity
Accidental Fall
Motivation
Older Adults
Interventions Behavioral: Otago Exercise Program
Device: Physical activity monitors (e.g., Fitbit)
Behavioral: Interpersonal Behavior Change Strategies
Behavioral: Intrapersonal Behavior Change Strategies
Other: Information about Health and Wellness
Enrollment 309
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Hide Arm/Group Description

Condition 1:

Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.

Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
Period Title: Overall Study
Started 78 78 76 77
Completed 77 76 74 75
Not Completed 1 2 2 2
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies Total
Hide Arm/Group Description

Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
 Total of all reporting groups
Overall Number of Baseline Participants 78 78 76 77 309
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 78 participants 76 participants 77 participants 309 participants
77.8  (5) 77.7  (5) 77.3  (5) 76.6  (5.1) 77.4  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 78 participants 76 participants 77 participants 309 participants
Female
64
  82.1%
59
  75.6%
59
  77.6%
58
  75.3%
240
  77.7%
Male
14
  17.9%
19
  24.4%
17
  22.4%
19
  24.7%
69
  22.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 78 participants 76 participants 77 participants 309 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.3%
0
   0.0%
1
   0.3%
Asian
0
   0.0%
1
   1.3%
1
   1.3%
1
   1.3%
3
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  16.7%
10
  12.8%
16
  21.1%
9
  11.7%
48
  15.5%
White
65
  83.3%
66
  84.6%
57
  75.0%
67
  87.0%
255
  82.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.3%
1
   1.3%
0
   0.0%
2
   0.6%
1.Primary Outcome
Title Quantity of Physical Activity Measured Objectively
Hide Description Average weekly minutes of total physical activity per week (light, moderate and vigorous intensities) as captured from PAM data (Fitbit Charge-2)
Time Frame Baseline and Post-Intervention (one week, six months, twelve months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Hide Arm/Group Description:

Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.
Overall Number of Participants Analyzed 78 78 76 77
Mean (Standard Deviation)
Unit of Measure: minutes per day
Baseline Number Analyzed 78 participants 78 participants 76 participants 77 participants
177.9  (62.2) 167.7  (79.1) 185.9  (70.5) 177.9  (72.7)
one week post-intervention Number Analyzed 77 participants 77 participants 75 participants 76 participants
180.5  (68.5) 193.1  (82.1) 181  (68.2) 209.1  (79.2)
six months post-intervention Number Analyzed 77 participants 77 participants 75 participants 75 participants
180  (73.8) 185.7  (84) 175.1  (68.9) 198  (78)
twelve months post-intervention Number Analyzed 77 participants 76 participants 74 participants 75 participants
174.3  (72.0) 190.3  (99.1) 167.7  (68.6) 192.9  (80.4)
2.Primary Outcome
Title Physical Activity Scale for the Elderly (PASE)
Hide Description Self-report Measure of Physical Activity. PASE is a validated questionnaire to measure the amount of physical activity in people over the age of 65 including types (e.g., walking, recreational, exercise, housework, care-giving). Scores, accounting for frequency, duration and intensity of physical activity are calculated and typically range from 0 to 793, with higher value representing more physical activity.
Time Frame Baseline and Post-Intervention (one week, six months, twelve months)
Hide Outcome Measure Data
Hide Analysis Population Description
Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Hide Arm/Group Description:

Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
Overall Number of Participants Analyzed 78 78 76 77
Mean (Standard Error)
Unit of Measure: Total PASE Score
Baseline Number Analyzed 78 participants 78 participants 76 participants 77 participants
102.2  (46.4) 108.3  (66.6) 110.6  (44) 101.8  (48.5)
One week post-intervention Number Analyzed 77 participants 77 participants 75 participants 76 participants
111.1  (47.3) 119.2  (69.9) 120.7  (56.2) 121.1  (58.7)
Six months post-intervention Number Analyzed 77 participants 77 participants 75 participants 75 participants
106.7  (53.0) 118.2  (65.1) 119.5  (65.8) 112.2  (60.1)
Twelve months post-intervention Number Analyzed 77 participants 76 participants 74 participants 75 participants
107.1  (60.0) 113.8  (66.8) 123.0  (92.3) 112.4  (60.9)
3.Secondary Outcome
Title Fall Rate
Hide Description Falls per person year, assessed via prospective monthly calendars
Time Frame 12 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Hide Arm/Group Description:

Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
Overall Number of Participants Analyzed 77 76 74 75
Measure Type: Number
Unit of Measure: Falls per person year
0.9 1.0 0.9 1.1
4.Secondary Outcome
Title Number of Participants With Moderate or Major Injuries From Falls
Hide Description Number of injuries from falls was measured via prospective falls calendars mailed to participants monthly with return addressed/stamped envelopes. Circumstances and injuries related to each fall were documented on the calendars. Calendar documentation each fall was verified and detailed through phone conversations between participants and trained research staff. Moderate and Major injuries from falls were categorized according to the Agency for Healthcare Research and Quality with moderate injuries defined as necessitating sutures, skin glue, splinting, and or involving muscle or joint strain. Major injuries were defined as those associated with internal injuries or a need for surgery, casting, traction, or neurological consults.
Time Frame 12 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Hide Arm/Group Description:

Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
Overall Number of Participants Analyzed 77 76 74 75
Measure Type: Number
Unit of Measure: Participants
Number of moderate injurious falls 6 7 6 6
Number of major injurious falls 1 2 2 1
5.Secondary Outcome
Title Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 Global Health
Hide Description

Using the Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Questionnaire 1.2. Two constructs from this questionnaire were converted to t scores: self-reported physical health and self-reported mental health. . Mean t scores are 50, which indicates the adult population mean with a standard deviation of 10. Higher t scores are considered better, or healthier, for self-reported physical health and mental health.

No clinically relevant thresholds were described in this study.
Time Frame Baseline and post-intervention: one-week, six months, and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number analyzed at baseline and post-intervention (one week, six months, twelve months) represent the number of participants in the study at that time. Numbers decrease across longitudinal time points due to participant withdrawal or loss to follow up
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Hide Arm/Group Description:

Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements
Overall Number of Participants Analyzed 78 78 76 77
Mean (Standard Deviation)
Unit of Measure: T score
Physical Health: Baseline Number Analyzed 78 participants 78 participants 76 participants 77 participants
39.2  (4.9) 39.5  (5.3) 39.1  (4.9) 40  (5.1)
Physical Health: Post-intervention, One week Number Analyzed 77 participants 77 participants 75 participants 76 participants
40.2  (4.7) 39.6  (5.5) 39.6  (4.6) 40.5  (5.0)
Physical Health: Post-intervention, six months Number Analyzed 77 participants 77 participants 75 participants 75 participants
38.7  (5.2) 38.7  (5.6) 39.2  (4.5) 40.0  (5.1)
Physical Health 12 months post-intervention Number Analyzed 77 participants 76 participants 74 participants 75 participants
39.5  (5.3) 39.1  (6.2) 38.9  (5.1) 39.3  (5.1)
Mental Health: Baseline Number Analyzed 78 participants 78 participants 76 participants 77 participants
50.8  (7.4) 52.3  (7.9) 51.8  (8.0) 52.9  (8.1)
Mental Health: Post-intervention, One week Number Analyzed 77 participants 77 participants 75 participants 76 participants
53.1  (7.1) 52.4  (7.9) 52.2  (8.3) 53.8  (8.0)
Mental Health: Post-intervention, Six months Number Analyzed 77 participants 77 participants 75 participants 75 participants
51.4  (7.0) 50.6  (8.2) 51.7  (7.4) 52.8  (8.4)
Mental Health: Post-intervention, Twelve months Number Analyzed 77 participants 76 participants 74 participants 75 participants
51.1  (7.4) 50.3  (8.3) 50.3  (7.4) 49.9  (8.3)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
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Condition 1:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Health and wellness information (attention control content) guided by content in the National Instituteon Aging (NIA) and Centers for Disease Control and Prevention websites.

Condition 2:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.

Condition 3:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movements.

Condition 4:

  1. Otago Exercise Program (OEP) adapted for delivery to small groups. In total, this protocol includes 5 flexibility movements, 5 leg-strengthening movements, and 12 balance-challenging movements. The number intensity and duration (dosages) are individualized according to preference and ability. OEP movements are gradually progressed across the 8-week intervention.
  2. A physical activity monitor (PAM) (Fitbit Charge 2) with initial orientation and ongoing support.
  3. Interpersonal behavior change strategies including peer-to-peer sharing and learning about using activities in everyday routines as prompts for movement, identifying and problem solving environmental barriers to physical activity, ways to increase social support for physical activity, and friendly social comparison of experiences performing OEP movements and home and other locations of choice, staying motivated to practice OEP movements long-term.
  4. Intrapersonal behavior change strategies including to develop physical activity related goals and action plans, self-assess goal attainment and action plan implementation-adjust accordingly, identify and problem solve personal barriers to physical activity, develop a habit of one or more OEP movement
All-Cause Mortality
Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/77 (1.30%)      2/76 (2.63%)      1/74 (1.35%)      0/75 (0.00%)    
Hide Serious Adverse Events
Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/77 (0.00%)      0/76 (0.00%)      0/74 (0.00%)      2/75 (2.67%)    
Cardiac disorders         
Stroke †  0/77 (0.00%)  0 0/76 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1
General disorders         
cancer †  0/77 (0.00%)  0 0/76 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Otago+PAM+Health / Wellness Topics Otago + PAM + Interpersonal Strategies Otago, PAM, Intrapersonal Strategies Otago,PAM, Inter+Intra Strategies
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/77 (2.60%)      7/76 (9.21%)      3/74 (4.05%)      3/75 (4.00%)    
General disorders         
Pain †  2/77 (2.60%)  2 1/76 (1.32%)  1 1/74 (1.35%)  1 1/75 (1.33%)  1
Fall †  0/77 (0.00%)  0 1/76 (1.32%)  1 0/74 (0.00%)  0 0/75 (0.00%)  0
fracture †  0/77 (0.00%)  0 2/76 (2.63%)  2 1/74 (1.35%)  1 0/75 (0.00%)  0
Polymyalgia rheumatica--unrelated †  0/77 (0.00%)  0 1/76 (1.32%)  1 0/74 (0.00%)  0 0/75 (0.00%)  0
cancer †  0/77 (0.00%)  0 0/76 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1
lung illness †  0/77 (0.00%)  0 0/76 (0.00%)  0 0/74 (0.00%)  0 1/75 (1.33%)  1
hyponatremia †  0/77 (0.00%)  0 1/76 (1.32%)  1 0/74 (0.00%)  0 0/75 (0.00%)  0
Infections and infestations         
Infection †  0/77 (0.00%)  0 1/76 (1.32%)  1 1/74 (1.35%)  1 0/75 (0.00%)  0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Siobhan McMahon
Organization: University of Minnesota
Phone: 612-625-3225
EMail: skmcmaho@umn.edu
Layout table for additonal information
Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03326141    
Other Study ID Numbers: 1607S90922
1R01NR016705-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 1, 2017
First Posted: October 31, 2017
Results First Submitted: January 28, 2024
Results First Posted: April 24, 2024
Last Update Posted: April 24, 2024