RERC on Technologies to Promote Exercise and Health Among People With Disabilities (A Scale Up Study Evaluating a Movement-to-Music Teleexercise Platform for Reaching a National Cohort of People With Spinal Cord Injury)

Spinal Cord Injury Program in Exercise - Monitoring/Evaluation (SCIPE-ME)

Sponsors

Lead sponsor: University of Alabama at Birmingham

Source University of Alabama at Birmingham
Brief Summary

The purpose of this study is to examine two versions of a home-based exercise program with 327 adults with spinal cord injury (SCI) who will be randomized into one of three groups: a) movement-to-music (M2M), b) standard exercise training (SET), and c) Attention control (ATT).

Detailed Description

The purpose of this study is to examine two versions of a home-based exercise program with 327 adults with spinal cord injury (SCI) who will be randomized into one of three groups: a) movement-to-music (M2M), b) standard exercise training (SET), and c) Attention control (ATT). The primary aim is to compare the effects of two 8-week home-based exercise interventions (M2M vs. SET) delivered through an eHealth platform on self-report physical activity and other health outcomes. The secondary aim of this study is to better understand the characteristics between compliant and non-compliant participants by evaluate the characteristics of participants, which includes age, race, sex, level of injury, type of injury, presence of social support, outcome expectations from exercise, confidence in maintaining exercise behavior, and ability to control and maintain exercise behavior. The characteristics will be evaluated among participant separated into 2 groups: 1) participants who completed ≥ 50% of the intervention; 2) participants who completed post-testing but < 50% of the intervention or who did not complete post-testing.

Overall Status Not yet recruiting
Start Date July 1, 2020
Completion Date September 30, 2022
Primary Completion Date August 30, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes from baseline physical activity level at week 8 Baseline and post 8 week intervention
Changes from baseline physical activity level at week 8 Baseline and post 8 week intervention
Changes from baseline pain intensity level at week 8 Baseline and post 8 week intervention
Changes from baseline pain interference at week 8 Baseline and post 8 week intervention
Changes from baseline fatigue level at week 8 Baseline and post 8 week intervention
Changes from Health-Related quality of life at week 8 Baseline and post 8 week intervention
Changes from quality of life(Social participation) at week 8 Baseline and post 8 week intervention
Changes from baseline sleep quality level at week 8 Baseline and post 8 week intervention
Secondary Outcome
Measure Time Frame
Changes in Adherence throughout the 8 weeks period Post 8 week intervention
Changes in Exercise Enjoyment at week 8 Post 8 week intervention
Enrollment 327
Condition
Intervention

Intervention type: Other

Intervention name: Movement-to-Music

Description: The M2M program has been developed for onsite instruction and will be repurposed into an eHealth version. The program is based on the positive effects of exercise and music on both physiological and psychosocial outcomes in people with disabilities. Investigators aim to advance our current M2M program by enabling more robust personalization features, allowing people with SCI to individualize their M2M program. Movement and tempo-based adaptations will also be available. A typical M2M session will consist of tailored movement routines starting with a warmup using range of motion exercises, followed by muscle strengthening, cardiorespiratory, and/or balance routines, and ending with a cool down emphasizing breathing and mindfulness.

Arm group label: Movement to Music (M2M)

Other name: M2M

Intervention type: Other

Intervention name: Standard Exercise Training

Description: The SET program is based on the NCHPAD 14-Weeks to a Healthier You program launched in 2008. Exercise videos including range of motion, muscle strengthening, cardio and balance routines performed both seated and standing have been developed and will be restructured for use in this study. The SET program will be delivered through the same platform as M2M.

Arm group label: Standardised Exercise Training (SET)

Other name: SET

Eligibility

Criteria:

Inclusion Criteria:

1. demonstrate readiness to physical activity by completing the online Physical Activity Readiness Questionnaire (PAR-Q);

2. have a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia;

3. have broadband internet access;

4. between the ages of 18 to 65 years;

5. have the ability to converse and read English.

Exclusion Criteria:

1. significant visual impairment that prevents seeing a computer screen to follow a home exercise program;

2. active pressure ulcer;

3. any contraindications to exercise based on the American College of Sports Medicine guidelines;

4. significant hearing impairment impeding ability to hear music to engage in exercise.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Overall Contact

Last name: Sangeetha Padalabalanarayanan, MS

Phone: 2059750550

Email: [email protected]

Verification Date

February 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Alabama at Birmingham

Investigator full name: James Rimmer

Investigator title: Director, UAB/Lakeshore Research Collaborative

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: Movement to Music (M2M)

Arm group type: Active Comparator

Description: Participants will attend three 60-minute M2M sessions per week for a total of 8 weeks. Each session will involve rhythmic-based exercises that are choreographed to music to target range of motion, muscle strength, cardiorespiratory fitness and balance.

Arm group label: Standardised Exercise Training (SET)

Arm group type: Active Comparator

Description: Participants will attend three 60-minute SET sessions per week for a total of 8 weeks. Each session will involve traditional exercises that target range of motion, muscle strength, cardiorespiratory fitness, and balance.

Arm group label: Attention Control (ATT)

Arm group type: No Intervention

Description: The ATT group will be provided with the NCHPAD's website and have access to its online programs, newsletter and NCHPAD's toll-free telephone number, email address and website.

Acronym SCIPE
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: Single (Outcomes Assessor)

Masking description: The outcome assessor will be blinded to participants' group assignments throughout the study.

Source: ClinicalTrials.gov