Clinical trial NCT03925077: Spinal Cord Injury Program in Exercise
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline physical activity level at week 8
timeFrame: Baseline and post 8 week intervention
Secondary outcomes:
measure: Changes from baseline pain intensity week 8
timeFrame: Baseline and post 8 week intervention
measure: Changes from baseline pain interference at week 8
timeFrame: Baseline and post 8 week intervention
measure: Changes from baseline sleep quality at week 8
timeFrame: Baseline and post 8 week intervention
measure: Changes from baseline fatigue level at week 8
timeFrame: Baseline and post 8 week intervention
measure: Changes from baseline health-related quality of life at week 8
timeFrame: Baseline and post 8 week intervention
measure: Changes from baseline ability to participate in social roles and activities at week 8
timeFrame: Baseline and post 8 week intervention
measure: Exercise enjoyment at week 8
timeFrame: Post 8 week intervention
Other outcomes:
measure: Baseline self-efficacy
timeFrame: Baseline
measure: Baseline self-regulation
timeFrame: Baseline
measure: Baseline social support
timeFrame: Baseline
measure: Baseline outcome expectations
timeFrame: Baseline
measure: Participant adherence throughout the 8-week intervention period
timeFrame: During the 8-week intervention
Locations:
city: Birmingham
country: United States
facility: RecTech Center
state: Alabama
Study officials:
References:
citation: Young HJ, Mehta T, Kim Y, Padalabalanarayanan S, Chiu CY, Rimmer JH, Thirumalai M. The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury. Trials. 2021 Aug 19;22(1):551. doi: 10.1186/s13063-021-05474-4.