Scale Up Evaluation of a Physical Activity Program for Adults With Physical Disability

NCT03024320 | Completed

• 1 other identifier: F160923002
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

Brief Summary

The study uses a theory-driven eHealth platform and innovative physical activity (PA) program referred to as movement-to-music (M2M) to deliver a customized, home-based PA intervention for adults with physical disability (PWD). Participants will be recruited through a large physical medicine and rehabilitation network of clinics specializing in treating patients with physical disability. Participants will be randomized to one of three groups: a) M2M; b) M2M plus social networking (M2Mplus); and c) attention control (AC). Participants will be followed for 48 weeks to obtain objective measures on physical activity, fitness and self-reported measures on health at four time points. The study will compare the effectiveness of M2M and M2Mplus in increasing physical activity and adherence compared to the AC group, estimate the improvements in health of M2M and M2Mplus compared to the AC group, and examine the mediators and moderators of the hypothesized treatment effect to understand for whom and how the intervention is effective. This multi-level, scalability study will strengthen our understanding of the potential benefits of eHealth to eliminate barriers to PA participation among PWD.

Conditions

Physical Disability

Outcome Measures

Primary Outcomes (2)

• Physical Activity

  Godin Leisure Time Exercise Questionnaire (GLTEQ) provides the Health Contribution Score which is calculated based on the number of minutes of physical activity multiplied by intensity level.

  48 weeks

• Completing program content

  Tracking tablet and Fitbit activity to know if participants are watching the exercise videos.

  48 weeks

Secondary Outcomes (17)

• Cardiorespiratory Endurance

  baseline, 12 weeks, 48 weeks

• Strength

  baseline, 12 weeks, 48 weeks

• Physical Function

  baseline, 12 weeks, 48 weeks

• Blood pressure

  baseline, 12 weeks, 48 weeks

• Height

  baseline, 12 weeks, 48 weeks

Study Arms (3)

M2M

EXPERIMENTAL

A theory-driven eHealth platform and innovative physical activity program referred to as movement-to-music (M2M), delivered customized and for the home-based for adults with physical disability.

Behavioral: M2M

M2Mplus

EXPERIMENTAL

A theory-driven eHealth platform and innovative physical activity program referred to as movement-to-music (M2M), delivered customized and for the home-based for adults with physical disability. This arm also includes a social networking platform where participants will be able to interact and encourage one another through the program, as well as group-based tele-coaching session.

Behavioral: M2M

Attention Control

ACTIVE COMPARATOR

Participants receive health-focused articles and infographics throughout 48 weeks and receive a Fitbit.

Behavioral: Attention Control

Interventions

M2M BEHAVIORAL

An eHealth platform has been designed to deliver a home-based package using the extensive set of movement patterns that have been adapted for people with a range of physical/mobility disability, called Movement-To-Music (M2M). The M2M prescription will be based on the participant's baseline level of health, function and fitness. Each movement pattern will be available in three different positions - standing, standing with support (chair) and seated. The duration of each M2M session will be gradually increased during the Adoption phase from three 20-minute sessions (10 min. aerobic \& 10 min. strength) during weeks 1 to 3 (60 min/wk), to 45-min sessions (30 min. aerobic \& 15 min. strength) during weeks 4 to 6 (135 min/wk), and to 50-min sessions (150 min/week) during weeks 7 to 12 (excluding 5-min warmup and 5-min cool down).

M2M; M2Mplus

Attention Control BEHAVIORAL

Telecoaching on health-based topics, not including physical activity.

Attention Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Underactive adults (\< 60 minutes of moderate intensity exercise per week in the last month)
• Diagnosis of a physical/mobility disability by their physician
• Working age adult 18 to 70 yrs. of age
• No physician contraindications to exercise and written physician approval to participate in the study
• Not currently enrolled in a structured exercise program over the past 6 months
• Have the ability to use upper, lower or both sets of extremities to exercise
• Must have the ability to converse and read English

You may not qualify if:

• Medically unstable to perform home exercise as determined by their physician
• High level tetraplegia and unable to use arms or legs to exercise
• Cognitive impairment that may preclude self-directed daily activities
• No internet access.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Lakeshore Foundation: collaborator
• Tanner Foundation for Multiple Sclerosis: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (5)

• Lai BW, Rimmer JH, Yates A, Jeter A, Young HJ, Thirumalai M, Mehta T, Wilroy J. Critical factors influencing the decision to enroll in a physical activity intervention among a predominant group of adults with spinal cord injury: a grounded theory study. Spinal Cord. 2021 Jan;59(1):17-25. doi: 10.1038/s41393-020-0530-7. Epub 2020 Aug 3.

  PMID: 32747672 BACKGROUND

• Rimmer JH, Mehta T, Wilroy J, Lai B, Young HJ, Kim Y, Pekmezi D, Thirumalai M. Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial. BMJ Open. 2019 Mar 30;9(3):e023538. doi: 10.1136/bmjopen-2018-023538.

  PMID: 30928927 BACKGROUND

• Lai B, Wilroy J, Young HJ, Howell J, Rimmer JH, Mehta T, Thirumalai M. A Mobile App to Promote Adapted Exercise and Social Networking for People With Physical Disabilities: Usability Study. JMIR Form Res. 2019 Mar 19;3(1):e11689. doi: 10.2196/11689.

  PMID: 30888325 BACKGROUND

• Wilroy JD, Lai B, Davlyatov G, Mehta T, Thirumalai M, Rimmer JH. Correlates of adherence in a home-based, self-managed exercise program tailored to wheelchair users with spinal cord injury. Spinal Cord. 2021 Jan;59(1):55-62. doi: 10.1038/s41393-020-0497-4. Epub 2020 Jun 15.

  PMID: 32541883 BACKGROUND

• Wilroy J, Lai B, Currie M, Young HJ, Thirumalai M, Mehta T, Giannone J, Rimmer J. Teleassessments for Enrollment of Adults With Physical or Mobility Disability in a Home-Based Exercise Trial in Response to COVID-19: Usability Study. JMIR Form Res. 2021 Nov 18;5(11):e29799. doi: 10.2196/29799.

  PMID: 34792477 BACKGROUND

Related Links

• Study Website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of UAB/Lakeshore Collaborative

Model Details: Randomized Controlled Trial with three arms.

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 18, 2017
• Study Start: April 18, 2018
• Primary Completion: October 28, 2022
• Study Completion: October 31, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)