Spinal Cord Injury Program in Exercise (SCIPE)

The University of Alabama at Birmingham

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Other: Standard Exercise Training; Other: Movement-to-Music

Study type: Interventional

Funder types: Other

Identifiers

NCT03925077

90DPGE0005 (Other Grant/Funding Number)

IRB-300003133

Details and patient eligibility

About

The purpose of this study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with spinal cord injury. Enrolled participants will be randomized into one of three groups: a) M2M, b) SET, and c) attention control (AC).

Full description

The purpose of the Spinal Cord Injury Program in Exercise (SCIPE) study is to examine two 8-week, remotely delivered exercise interventions: Movement-to-Music (M2M) and Standard Exercise Training (SET), with 327 adults with SCI. The primary aim is to examine change in physical activity level after the 8-week M2M and SET interventions. We hypothesize that participants in M2M and SET will have significant increase in physical activity compared to an Attention Control (AC) group after the 8-week intervention. The secondary aim is to examine effects of the M2M and SET interventions on health and quality of life outcomes. We hypothesize that participants in M2M and SET will have significant increases in sleep quality and quality of life and decreases in pain and fatigue compared to AC after the 8-week intervention. Exercise enjoyment in M2M and SET participants will also be explored. The tertiary aim is to evaluate the demographic (age, race, sex), clinical (level of injury, type of injury), and psychosocial (social support, outcome expectations, self-efficacy, self-regulation) variables of two participant groups: 1) compliant participants who completed ≥ 50% of the intervention, and 2) noncompliant participants who completed post-testing but < 50% of the intervention or who did not complete post-testing.

Enrollment: 96 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with a SCI resulting in incomplete or complete (C5 and below) paraplegia or tetraplegia;
2. Demonstrate readiness to physical activity by completing the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+);
3. Obtain medical clearance if required by PAR-Q+;
4. Converse in and read English.

Exclusion criteria

1. No broadband internet access;
2. Significant visual impairment that prevents seeing a computer screen to follow a home exercise program;
3. Currently pregnant.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 5 patient groups

Phase 1: Movement-to-Music (M2M)

Active Comparator group

Description:

All M2M sessions are delivered using videos uploaded to a secure study website (the SCIPE website). Participants in M2M will have access to the website and attend three 60-minute M2M sessions per week for a total of 8 weeks. Each session provides rhythmic-based exercises that are choreographed to music to target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.

Treatment:

Other: Movement-to-Music

Phase 1: Standard Exercise Training (SET)

Active Comparator group

Description:

All SET sessions are delivered using videos uploaded to the SCIPE website. Participants in SET will have access to the website and attend three 60-minute SET sessions per week for a total of 8 weeks. Each session provides traditional exercises that target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in SET will receive and read weekly educational articles on health and fitness through the SCIPE website.

Treatment:

Other: Standard Exercise Training

Phase 1: Attention Control (AC)

No Intervention group

Description:

Participants in AC will not have access to any exercise videos. They will have access to the weekly educational articles on health and fitness, same as the ones received by the M2M and SET groups, through the SCIPE website.

Phase 2: Standard Exercise Training (SET)

Active Comparator group

Description:

All SET sessions are delivered using videos uploaded to the SCIPE website. Participants in SET will have access to the website and attend three 60-minute SET sessions per week for a total of 8 weeks. Each session provides traditional exercises that target range of motion, muscular strength, cardiorespiratory fitness, and balance. In addition, participants in SET will receive and read weekly educational articles on health and fitness through the SCIPE website.

Treatment:

Other: Standard Exercise Training

Phase 2: Attention Control (AC)

No Intervention group

Description:

Participants in AC will not have access to any exercise videos. They will have access to the weekly educational articles on health and fitness, same as the ones received by the M2M and SET groups, through the SCIPE website.