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

NCT03024320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2022-11-02

No results posted yet for this study

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

Interventions

BEHAVIORAL

M2M

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).

BEHAVIORAL

Attention Control

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

Sponsors & Collaborators

  • Lakeshore Foundation

    collaborator OTHER

  • Tanner Foundation for Multiple Sclerosis

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2022-10-28
Completion
2022-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03024320 on ClinicalTrials.gov