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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05216393
Other study ID # 300007761
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2024
Est. completion date August 1, 2024

Study information

Verified date February 2024
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The multilevel socio-ecological barriers to physical activity experienced by people with physical disabilities cut across structures and systems, community, institutions and organizations, interpersonal, and individual levels. Several studies have attempted to understand these barriers and facilitators, but to date, no study or system has attempted to systematically resolve these multilevel barriers and capitalize on the potential facilitators that can increase access to exercise and recreation programs, services and facilities for people with disabilities. In RecTech's previous cycle of funding, this void was addressed in a Proof of Concept product called the Activity Inclusion Mapping System (AIMS). AIMS enabled people with disabilities to quickly and precisely identify accessible and usable community-based physical activity resources and services. Based on the positive feedback received at the annual RESNA conference and from our Consumer Research Advisory Committee (CRAC) during preparation of this application, the investigators propose to develop an innovative person-centered geotagged Social Networking System (SNS) based on the social-ecological model of health. The focus of this proposed Proof of Product project is to address multilevel barriers and facilitators associated with community-based leisure time physical activity (LTPA) using crowdsourcing principles for gathering data. The project is targeted to all people with physical disabilities.


Description:

The stage of development for a RecTech Match website is a Proof of Product. The RecTech Match website will be a new online resource that will provide physical activity resources inclusive of people with disabilities. Users will be able to search for accessible opportunities for physical activity near them, watch videos on-demand related to exercise, and read articles to learn about exercise or introduce them to new community exercise opportunities. Once successful feasibility testing is completed, the investigators will work with nchpad.org, to seed information and launch nationally. Thirty users with physical disabilities, ages 18 to 64, will participate in a 12-wk two-arm parallel randomized control trial (15 per group) aimed at reducing barriers to physical activity, increasing social support and increasing leisure-time physical activity minutes. A sample of 15 per arm will be sufficient for our pilot/feasibility study. The control arm will have access to generic information available on the National Center on Health Physical Activity and Disability (NCHPAD) website, which includes the same information but is not delivered through RecTechMatch.com. All users will be recruited online. Fitbit sensors will be provided to participants to objectively measure physical activity minutes Process feasibility outcome measures will include recruitment, retention and adherence, and Intervention efficacy outcomes will include the Godin-Shephard Leisure-Time Physical Activity Questionnaire, the Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI), and Chogahara's Social Influence on Physical Activity questionnaire. Daily self-report physical activity will be collected by secure email or text. Health Coaching calls and exit interviews will be recorded via Twilio Flex. After baseline assessments are completed by all participants, each will be randomized to the 2 study arms in a 1:1 Each participant will be randomly assigned (through REDCap) to 1 of 2 treatment conditions: (1) RecTech match intervention with tele-coaching support, and (2) control. All participants will receive a welcome call and asked to provide days and times that are most convenient to attend tele-health coaching calls. Intervention group participants will receive an orientation call once shipment is received of the Fitbit device to help set the device up and ready for data collection. The intervention group will be mailed a Fitbit device and provided access to the RecTech Match website. These participants will receive weekly calls for the first 6 weeks, and a call every other week for the following 6 weeks (9 in total) from a health coach to discuss intervention progress, facilitate setting physical activity goals, and help mitigate obstacles to participate in physical activity in the community. Participants will be free to access the features and resources of the website. The Fitbit data will be collected on an ongoing basis and the participants will receive daily texts asking them to rate the amount of physical activity for the day. The control participants will not have access to the RecTech Match website; however, control participants will be directed to generic information available on the NCHPAD website, which includes the same information but is not delivered through RecTechMatch.com. All participants will receive survey packets through RedCap's auto-delivery system. Survey packets will be delivered at 12 and 24 weeks. Additionally, Intervention participants will participate in a short exit interview.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date August 1, 2024
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: 1. 18 to 64 years old 2. self-reported physical disability that limits their mobility Exclusion Criteria: 1. Cognitive or linguistic problems with understanding instructions or filling in self-administered outcome measures 2. Cardiovascular disease event within the past 6 months 3. Severe pulmonary disease or renal failure 4. Currently pregnant 5. Ongoing exacerbation of a health condition 6. Other conditions that would interfere with being physically active

Study Design


Related Conditions & MeSH terms


Intervention

Other:
RecTech Match Website
Participants will have access to the Rectech Match website. These participants will receive 9 health coaching calls. Fitbit physical activity data will be collected on an ongoing basis during the intervention.

Locations

Country Name City State
United States UAB / Lakeshore Research Collaborative Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (6)

Amireault S, Godin G. The Godin-Shephard leisure-time physical activity questionnaire: validity evidence supporting its use for classifying healthy adults into active and insufficiently active categories. Percept Mot Skills. 2015 Apr;120(2):604-22. doi: 10.2466/03.27.PMS.120v19x7. Epub 2015 Mar 23. — View Citation

Chogahara M. A multidimensional scale for assessing positive and negative social influences on physical activity in older adults. J Gerontol B Psychol Sci Soc Sci. 1999 Nov;54(6):S356-67. doi: 10.1093/geronb/54b.6.s356. — View Citation

Martin Ginis KA, Ma JK, Latimer-Cheung AE, Rimmer JH. A systematic review of review articles addressing factors related to physical activity participation among children and adults with physical disabilities. Health Psychol Rev. 2016 Dec;10(4):478-494. doi: 10.1080/17437199.2016.1198240. Epub 2016 Jun 29. — View Citation

McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988 Winter;15(4):351-77. doi: 10.1177/109019818801500401. — View Citation

Takacs J, Pollock CL, Guenther JR, Bahar M, Napier C, Hunt MA. Validation of the Fitbit One activity monitor device during treadmill walking. J Sci Med Sport. 2014 Sep;17(5):496-500. doi: 10.1016/j.jsams.2013.10.241. Epub 2013 Oct 31. — View Citation

Vasudevan V, Rimmer JH, Kviz F. Development of the Barriers to Physical Activity Questionnaire for People with Mobility Impairments. Disabil Health J. 2015 Oct;8(4):547-56. doi: 10.1016/j.dhjo.2015.04.007. Epub 2015 May 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Godin - Leisure time physical activity questionnaire Estimates habitual leisure time physical activity. Higher numbers indicate more times the person has engaged in physical activity separated by 3 categories. There is no scoring limit. pre-intervention and again at the end of 12 weeks
Primary Barriers to Physical Activity Questionnaire for People with Mobility Impairments Identifies barriers to physical activity, specifically designed for individuals with a mobility. impairment. The survey has 8 subscales (health, beliefs and attitudes, family, friends, fitness-center-built environment, staff and policy, community built environment, and safety. Subscale scores of 1 to 5 are calculated. Higher values indicate a higher influence of barriers. pre-intervention and again at the end of 12 weeks
Primary Chogahara's Social Influence on Physical Activity Questionnaire Measures a persons perceptions on how their physical activity is affected by social influences. The survey has 3 factors (friends, family, and health/fitness expert) and 3 subscales (companionship, informational, and emotional support). Each subscale can have a minimum maximum score of 4 with a higher score indicating a higher frequency of influence. pre-intervention and again at the end of 12 weeks
Primary Post Intervention Interviews Gather feedback on the end user's experiences using the website. pre-intervention and again at the end of 12 weeks
Secondary FitBit device data (total energy expenditure, steps, sedentary time, light activity time, moderate activity time, high activity time, and activity energy expenditure). The Fitbit device reports, the total amount of energy expended (kCal) per day, the number of steps achieved per day, the number of minutes that the wearer engaged either sedentary activity or physical activity (light, moderate, high), and finally the energy expenditure cost of the physical activity (kCAL) per day. FitBit Data will be continuously collected for 12 weeks
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