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Nordic Walking to Manage Falls and Fear of Falling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05965011
Recruitment Status : Completed
First Posted : July 28, 2023
Last Update Posted : December 13, 2023
Sponsor:
Information provided by (Responsible Party):
Dr. Mohammad Auais, PhD, Queen's University

Study Description
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Brief Summary:

This is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.

Participants will be asked to:

  • Attend training sessions to learn proper Nordic Walking techniques.
  • Engage in supervised Nordic Walking sessions for a specified duration and frequency.
  • Keep a log of their walking activities and any falls or near falls experienced.
  • Complete questionnaires to assess their fear of falling and overall physical activity levels.

If there is a comparison group:

Researchers will compare the intervention group, consisting of older adults participating in the Nordic Walking program, with a control group of older adults who do not receive the intervention. The comparison will be made to determine if Nordic Walking has a significant impact on reducing falls and fear of falling compared to the control group.


Condition or disease Intervention/treatment Phase
Risk of Falling Other: Exercise training Not Applicable

Detailed Description:

Introduction:

this is a pilot study that aims to test the feasibility and safety of a novel Nordic Walking (NW) activity program for community-dwelling older adults who are at risk of falling or experience fear of falling (FOF). The study also aims to determine the distribution and effect sizes of outcomes to inform future sample size calculations and explore participants' perspectives of the intervention.

Background:

Falls and fear of falling are significant concerns among older adults, leading to physical impairments, psychological trauma, and a decline in abilities and quality of life. Exercise has been shown to be effective in improving muscle strength, balance, mobility, and postural control, all of which are risk factors for falls and FOF. However, traditional exercise programs have limitations in terms of cost, sustainability, and long-term adherence. Nordic Walking, a low-risk and low-tech intervention, has emerged as a promising alternative, offering numerous physical and mental health benefits.

Study Design:

The study will be conducted in two stages. Stage One will involve a two-arm, parallel, single-blind, randomized controlled pilot trial. Forty older adults at risk of falling will be recruited and randomly assigned to either a 10-week NW intervention group or a control group. The intervention group will receive supervised NW training sessions and will be coached to practice independently. The control group will receive regular phone calls to discuss healthy lifestyle habits.

Outcome Measures:

The study will collect feasibility and safety data, including recruitment, adherence, and follow-up rates, as well as adverse events. Effectiveness outcomes will be assessed using measures such as the Timed Up and Go (TUG) test, Stay Independent Falls Risk Assessment Tool, Falls Efficacy Scale-International (FES-I), Activities-Specific Balance Confidence Scale, and the Four-Square Step Test (FSST).

Data Analysis:

Descriptive statistics will be used to characterize participants and feasibility measures. Hedge's effect size and confidence intervals will be calculated. Independent samples t-tests and chi-square tests will be used to compare the intervention and control groups. The main focus of the analysis will be to estimate the effect size, test the intervention's feasibility and safety, and inform future studies.

Sample Size:

The study aims to recruit 40 participants (20 per group) to ensure study robustness and account for potential dropouts.

Stage Two:

In the second stage, qualitative interviews will be conducted with all participants in the intervention group to gather feedback on the acceptability, perceived value, barriers, and facilitators of participating. The data will be analyzed using interpretive description to identify themes and categories.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a pilot trial conducted as a two-arm, parallel, single-blind, randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: The single-blind design will involve that the assessors are unaware of the group assignments.
Primary Purpose: Prevention
Official Title: Walking on 'Four Legs' to Manage Falls and Fear of Falling
Actual Study Start Date : August 29, 2022
Actual Primary Completion Date : October 15, 2023
Actual Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention (Nordic walking)

Nordic walking training. These coaching principles will focus on highlighting the participants' strengths and resourcefulness, setting goals, and utilizing solution-focused problem-solving techniques to achieve those goals during practice and related activities . This group sessions will be conducted biweekly to ensure appropriate progression and adherence to the guidelines set by the International Nordic Walking Federation.

In addition to the supervised group sessions, participants will also receive supervised NW training from a certified NW instructor. Participants will be encouraged to set goals and develop strategies to facilitate independent practice for at least three 30-minute sessions per week over a period of 10 weeks. These unsupervised sessions aim to encourage participants to engage in regular practice outside of the group sessions.

 Other: Exercise training
The intervention will be a combination of both supervised and unsupervised sessions. Participants in the Nordic Walking (NW) treatment group will attend 5 one-hour group sessions, which will incorporate coaching principles.
Other Name: Nordic walking
No Intervention: Control (phone calls)

The control group will receive regular contact to control for attention and maintain participant engagement throughout the study. Over the course of the 10 weeks, participants in this group will receive 5 biweekly phone calls from the study's graduate research assistant (RA).

During each phone call, the RA will engage in discussions with participants about leading a healthy lifestyle in general, covering topics such as proper nutrition and adequate sleep. Additionally, the RA will gather safety-related data, including information on any falls that may have occurred. The phone calls will also serve as reminders for participants about upcoming assessments and their importance in the study. The investigators will provide a training session to the control group following the completion of the study if they are interested.


Outcome Measures
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Primary Outcome Measures :
  1. Estimate the effect size of intervention (Cohen's D) [ Time Frame: Through study completion, an average of 1.5 years ]
    Effect size estimation is vital in assessing the impact of interventions like Nordic walking and planning future studies. It involves quantifying the magnitude of the intervention's effect on the outcome variable.

  2. Evaluate the adherence rate to the intervention (as a measure of feasibility) [ Time Frame: Through study completion, an average of 1.5 years ]
    Participant Adherence to the Intervention: This measure examines the extent to which participants adhere to the prescribed Nordic walking program. It involves tracking the frequency, duration, and intensity of Nordic walking sessions completed by participants. Adherence rates can be calculated based on the number of sessions attended or completed as planned.

  3. Assess safety of the intervention [ Time Frame: Through study completion, an average of 1.5 years ]
    Monitoring Adverse Events: We systematically record and monitor any adverse events or incidents during the study. This includes injuries, discomfort, or any negative effects reported by participants.


Secondary Outcome Measures :
  1. Timed Up and Go (TUG) to assess fall risk [ Time Frame: Pre (week 0) /post intervention (week 11) ]
    The Timed Up and Go (TUG) test is a widely used clinical assessment tool to evaluate mobility and functional mobility, specifically in older adults. While it is not specifically designed to determine the risk of falling, it can provide valuable information that is correlated with fall risk. The TUG test measures the time it takes for an individual to stand up from a chair, walk a set distance (typically 3 meters), turn around, return to the chair, and sit down again.

  2. Fear of Falling: Fear of falling will be measured by the Falls Efficacy Scale-International (FES-I) [ Time Frame: Pre (week 0) /post intervention (week 11) ]
    Scale: Falls Efficacy Scale-International (FES-I) Minimum Value: 0 (not at all confident) Maximum Value: 100 (completely confident) Interpretation: In the FES-I, higher scores indicate greater fear of falling. Therefore, a higher score on the FES-I reflects a worse outcome, indicating a higher level of fear and reduced confidence in performing daily activities without falling. Conversely, a lower score on the FES-I suggests a better outcome, indicating a lower level of fear and greater confidence in performing activities without fear of falling.

  3. Performance on the Four-Square Step Test (FSST) will be measured to assess balance. [ Time Frame: Pre (week 0) /post intervention (week 11) ]

    The Four-Square Step Test (FSST) does not yield a specific score on a scale like some other assessments. Instead, the FSST primarily focuses on the time taken to complete the test and the occurrence of errors or missteps.

    When assessing FSST performance, the following information is typically recorded:

    Completion Time: The time the individual takes to complete the FSST is measured in seconds. A shorter completion time generally indicates better balance and agility.

    Errors or Missteps: The number of errors or missteps made by the individual during the FSST is recorded. Errors can include stepping outside the designated squares, incorrect foot placement, or loss of balance. Fewer errors suggest better balance control and coordination.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be 60+ years old.
  • Be at risk of falling, as determined by the Stay Independent Falls Risk Assessment Tool. This validated tool is recommended by the STEADI fall prevention program to evaluate risk of falling.

Exclusion Criteria:

  • Inability to use walking poles due to medical conditions.
  • Inability to walk 400m independently.
  • Having a medical condition such as unstable cardiorespiratory status, impending angioplasty, or ataxia/dyskinesia (unsteady, staggering gait) that prevents them from participating in physical activities or using walking poles is prohibited.
  • Taking part in any other structured exercise program.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05965011


Locations
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Canada, Ontario
School of Rehabilitation Therapy, Queens University
Kingston, Ontario, Canada
Sponsors and Collaborators
Dr. Mohammad Auais, PhD
More Information
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Publications:
Keast M-L. Nordic walking: introducing a new low-impact exercise system for cardiac rehabilitation patients. Minto prevention and rehabilitation center, University of Ottawa Heart Institute. 2009:13- 14.
Ossowski Z, Wawryniku M, Česnaitiene V. Influence of nordic walking training on static and dynamic body balance among the elderly. Baltic Journal of Health and Physical Activity. 2015;7(1):72-80.
Karawan A, Porcari J, Butta H, Postmus A, Stoughton L, Larkin J. Effects of 12 weeks of walking or exerstriding on upper body strength and endurance. Medicine & Science in Sports & Exercise. 1992;24(5):S138.
International Nordic Walking Federation. http://inwa-nordicwalking.com/. Accessed May 2021.
Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics: The Journal of Applied Statistics in the Pharmaceutical Industry. 2005;4(4):287-291.
Parachute. Fall prevention. 2014. https://parachute.ca/en/injury-topic/fall-prevention-for-seniors/. Accessed Mar 2021
Watzek D, Mischler E, Sonam D, et al. Effectiveness and economic evaluation of therapeutic nordic walking in patients with psychosomatic disorders: A pragmatic randomized controlled trial. Psychology. 2016;6(11):665-675.
Dishman RK. Increasing and maintaining exercise and physical activity. Behavior Therapy. 1991;22(3):345-378. 10
Jordan AN, Olson TP, Earnest CP, Morss GM, Church TS. Metabolic cost of high intensity poling while nordic walking versus normal walking. Medicine & Science in Sports & Exercise. 2001;33(5):S86.
Ossowski Z, Prusik K, Prusik K, Kortas J, Wiech M. Nordic walking training and physical fitness in elderly women. Polish Journal of Sport and Tourism. 2015;21(4):253-257.
Šokelienė V, Česnaitienė VJ. The influence of nordic walking on physical fitness of elderly people. Baltic Journal of Sport and Health Sciences. 2011;3(82).
Queens Gazette. How the School of Rehabilitation Therapy is breaking down barriers to physiotherapy in the Kingston community. In. Kingston, Ontraio, Canada 2021:https://healthsci.queensu.ca/stories/feature/how-school-rehabilitation-therapy-breaking-down barriers-physiotherapy-kingston.

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Responsible Party: Dr. Mohammad Auais, PhD, Assistant Professor, School Of Rehabilitation Therapy, Queen's University
ClinicalTrials.gov Identifier: NCT05965011    
Other Study ID Numbers: 6030812
First Posted: July 28, 2023    Key Record Dates
Last Update Posted: December 13, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Mohammad Auais, PhD, Queen's University:
Fear of Falling
Nordic Walking
Older adults