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

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ClinicalTrials.gov Identifier: NCT03024320
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Lakeshore Foundation
Information provided by (Responsible Party):
James Rimmer, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Physical Disability Behavioral: M2M Behavioral: Attention Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial with three arms.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Scale Up Evaluation of a Physical Activity Program for Adults With Physical Disability
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: M2M
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
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).

Experimental: M2Mplus
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
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).

Active Comparator: Attention Control
Participants receive health-focused articles and infographics throughout 48 weeks and receive a Fitbit.
Behavioral: Attention Control
Telecoaching on health-based topics, not including physical activity.




Primary Outcome Measures :
  1. Physical Activity [ Time Frame: 48 weeks ]
    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.

  2. Completing program content [ Time Frame: 48 weeks ]
    Tracking tablet and Fitbit activity to know if participants are watching the exercise videos.


Secondary Outcome Measures :
  1. Cardiorespiratory Endurance [ Time Frame: baseline, 12 weeks, 48 weeks ]
    Sub-max Arm Ergometer Test

  2. Strength [ Time Frame: baseline, 12 weeks, 48 weeks ]
    grip strength

  3. Physical Function [ Time Frame: baseline, 12 weeks, 48 weeks ]
    physical performance battery

  4. Blood pressure [ Time Frame: baseline, 12 weeks, 48 weeks ]
    Two readings prior to exercise using BP cuffs.

  5. Height [ Time Frame: baseline, 12 weeks, 48 weeks ]
    Standing or lying measured in inches and centimeters.

  6. Weight [ Time Frame: baseline, 12 weeks, 48 weeks ]
    Scale

  7. BMI [ Time Frame: baseline, 12 weeks, 48 weeks ]
    Body Mass Index

  8. Waist Circumference [ Time Frame: baseline, 12 weeks, 48 weeks ]
    Hip and naval.

  9. Barriers to Physical Activity and Disability Survey [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Barriers to Physical Activity for people with disabilities.

  10. Outcome Expectations for Exercise Scale [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Survey of social cognitive theory construct.

  11. Strategies for Physical Activity Scale [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Self-regulation measurement.

  12. Physical Activity Self-efficacy Scale [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Survey of social cognitive theory construct.

  13. Demographics [ Time Frame: baseline ]
    questionnaire

  14. Quality of Life [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Secondary health conditions NIH PROMIS

  15. Sleep [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Secondary health conditions NIH PROMIS

  16. Fatigue [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    NIH PROMIS

  17. Pain Intensity [ Time Frame: baseline, 12 weeks, 24 weeks, 48 weeks ]
    Secondary health conditions NIH PROMIS



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:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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): NCT03024320


Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: James Rimmer    205-975-9010    jrimmer@uab.edu   
Principal Investigator: James Rimmer, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Lakeshore Foundation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Rimmer, Professor and Director of UAB/Lakeshore Collaborative, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03024320    
Other Study ID Numbers: F160923002
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
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