physicAl aCtiviTy In minOrity womeN With Asthma Intervention (ACTION)

• ClinicalTrials.gov Identifier: NCT03265665
• Recruitment Status: Completed
• First Posted: August 29, 2017
• Results First Posted: February 23, 2022
• Last Update Posted: February 23, 2022
• Sponsor: University of Illinois at Chicago
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Sharmilee Nyenhuis, University of Illinois at Chicago

Study Description

Brief Summary:

The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a 3lifestyle physical activity intervention refined to be applicable for sedentary African American (AA) women with asthma. The main outcome of this study is to test the feasibility, acceptability and estimate the efficacy of the ACTION intervention in a randomized controlled pilot of 80 AA women with asthma within a pragmatic community setting at 24-weeks.

Condition or disease	Intervention/treatment	Phase
Asthma	Behavioral: ACTION Intervention; Other: Enhanced usual care	Not Applicable

Detailed Description:

Asthma is a highly prevalent chronic disease that disproportionately impacts African American (AA) women. AA women have poorer asthma-related quality of life and higher rates of asthma exacerbations, healthcare utilization and mortality compared to Caucasian women. Further, AA women are less physically active than any other subgroup of adults, which may help explain the asthma health disparities, found between AA and Caucasian women. Physical inactivity among individuals with asthma is associated with poor asthma control and respiratory function, greater health care utilization, and poorer quality of life. Given the connection between poor asthma outcomes and physical inactivity, addressing physical activity (PA) among sedentary AA women with asthma is imperative. Physical activity demonstrated improvement in asthma outcomes specifically asthma control, quality of life and healthcare utilization. Despite these benefits, fewer than 25% of AA women with asthma engage in regular physical activity. The ACTION intervention: physicAl aCtiviTy In minOrity womeN with asthma is a lifestyle PA intervention refined to be applicable for sedentary AA women with asthma.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: ACTION: physicAl aCtiviTy In minOrity womeN With Asthma Intervention
• Actual Study Start Date: October 1, 2017
• Actual Primary Completion Date: June 15, 2019
• Actual Study Completion Date: September 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: ACTION Intervention; Women in the ACTION intervention will attend 1 asthma education/physical activity session and 5 group sessions in community location convenient to participants during the adoptive phase (24-weeks) and 1 group session during the maintenance phase (12-weeks). Each session will last approximately 2 hours. Participants will be given Fitbit Charge HR to monitor their daily steps and will be sent motivational, educational and reminder text messages up to 3 times per week.	Behavioral: ACTION Intervention; The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.; Other Name: Group sessions
Enhanced usual care; Women in the Enhanced usual care arm will attend 1 asthma education/physical activity session and be given a Fitbit Charge HR to monitor their daily steps. They will be given a static step goal to achieve. Only reminder text messages for data collection visits will be sent.	Other: Enhanced usual care; Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.

Outcome Measures

Primary Outcome Measures :

1. Feasibility of Intervention-Recruitment [ Time Frame: 24 weeks ]
   The total number of participants recruited and consented in the study.
2. Feasibility of Intervention-Withdrawals [ Time Frame: 24 weeks ]
   Number of participants that withdrew from the study
3. Feasibility of Lifestyle PA Intervention [ Time Frame: 24 weeks ]
   Number of participants that completed 24-week outcomes assessment
4. Acceptability of Lifestyle PA Intervention [ Time Frame: 24-weeks ]
   Unabbreviated scale title: ACTION Satisfaction Scale. Acceptability was measured using a 7-point Likert scale with 1 representing not satisfied and 7 representing very satisfied. Higher scores mean more satisfied with the intervention. The range is from 1-7.
5. Acceptability of Lifestyle PA Intervention-Qualitative Data [ Time Frame: 24-weeks ]
   Intervention participants were asked open-ended questions about their satisfaction with the study. Responses were written down by the participant and data collector. It is not possible to summarize the data collected from the open-ended questions in tabular form as it is qualitative data.

Secondary Outcome Measures :

1. Light Physical Activity Levels [ Time Frame: 24 weeks ]
   as measured by accelerometer and using proprietary Actilife software
2. Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: 24 weeks ]
   The Asthma Quality of Life Questionnaire (AQLQ) is a 32-item questionnaire. It has 4 domains: symptoms (12 items), activity limitation (6 generic and 5 patient-specific items), emotional function (5 items), and environmental stimuli (4 items). The AQLQ items are each scored on a 7-point Likert scale, with 1 representing maximal impairment and 7 representing no impairment. Scores range 1-7, with higher scores indicating better quality of life. A total score was calculated by summing all responses for each question and then dividing by the number of items in the questionnaire (n=32). Subdomains were not reported/used.
3. Asthma Control Questionnaire (ACQ-6) [ Time Frame: 24 weeks ]
   Unabbreviated scale title: Asthma control questionnaire (ACQ) The ACQ score correlates with a measure of asthma control based on the GINA/NIH criteria. ACQ includes 6 questions on symptoms, activity limitation and beta2-agonist use. Each question is scored from 0 to 6 with the total score being the average of the questions. The ACQ score ranges between 0 (well controlled) and 6 (extremely poorly controlled). Recent studies show that a score of 1.5 or more on the 6-item Asthma Control Questionnaire (ACQ) indicates that a patient has inadequate asthma control.Higher scores mean poorer asthma control.
4. Daily Step Counts [ Time Frame: 24 weeks ]
   as measured by accelerometer
5. Moderate Physical Activity Levels [ Time Frame: 24 weeks ]
   as measured by accelerometer and using proprietary Actilife software
6. Vigorous Physical Activity Levels [ Time Frame: 24 weeks ]
   as measured by accelerometer and using proprietary Actilife software

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: The focus population for this study is sedentary African-American (AA) women with asthma. All participants included in the study will self-identify themselves as female and AA. This study population was chosen as AA women are disproportionately impacted by physical inactivity and asthma compared to Caucasian men and women and AA men.
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Self-identify as female and black or AA
• Age 18-70
• Sub-optimally controlled persistent asthma based on Asthma Control Test (ACT <20)
• Wiling to enroll and provide written-informed consent
• Willing to be randomly assigned to treatment or control group

Exclusion Criteria: • Plans to relocate outside of the Chicagoland area during the study period.

• Unable to ambulate without human assistance (ie. use of a wheelchair, scooter)
• History of significant mental illness (e.g. uncontrolled bipolar disorder, psychoses)
• Currently pregnant, planning to become pregnant over the next 3 months
• Diagnosis of COPD (emphysema or chronic bronchitis) suggested by patient report of doctor diagnosis or smoking history (>20 pack years)
• Poorly controlled high blood pressure (BP >180/100 at baseline visit)
• Family/household member of another study participant or staff member
• Inability to speak, read or understand English;
• Investigator discretion for safety or protocol adherence reasons
• Participation in ACTION focus groups (Aim 1) or pre-pilot (Aim 2) of the study

Contacts and Locations

Locations

United States, Illinois

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

University of Illinois at Chicago

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Sharmilee M Nyenhuis, MD; University of Illinois at Chicago

  Study Documents (Full-Text)

Documents provided by Sharmilee Nyenhuis, University of Illinois at Chicago:

Study Protocol and Statistical Analysis Plan  [PDF] April 23, 2021

More Information

• Responsible Party: Sharmilee Nyenhuis, Associate Professor of Medicine, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT03265665
• Other Study ID Numbers: 2016-0466; K01HL133370 ( U.S. NIH Grant/Contract )
• First Posted: August 29, 2017
• Results First Posted: February 23, 2022
• Last Update Posted: February 23, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sharmilee Nyenhuis, University of Illinois at Chicago:

walking; African American women; lifestyle

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases