Spinal Cord Injury Program in Exercise

Not Applicable

Active, not recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Other: Movement-to-Music; Other: Standard Exercise Training

• Registration Number: NCT03925077
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-20
• Study First Posted: 2019-04-23
• Study Start: 2021-02-01
• Primary Completion: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Movement to Music (M2M)	Movement-to-Music	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.
Standardised Exercise Training (SET)	Standard Exercise Training	All M2M 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 M2M will receive and read weekly educational articles on health and fitness through the SCIPE website.

Primary Outcome Measures

Name	Time	Method
Changes from baseline physical activity level at week 8	Baseline and post 8 week intervention	Physical activity is assessed using the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury (LTPAQ-SCI). The LTPAQ-SCI is a 3-item, self-report questionnaire that measures the number of days and minutes people with SCI spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days.

Secondary Outcome Measures

Name	Time	Method
Changes from baseline health-related quality of life at week 8	Baseline and post 8 week intervention	Health-related quality of life is assessed using the NIH PROMIS 10 Global Health Items. The Global-10 Health form is a 10-item measure with the response scores ranging from 1 (Poor/Not at all/Always/Very severe) to 5 (Excellent/Completely/Never/None). One question item, "how would you rate your pain on average?", is on a 11-point Likert scale that ranges from 0 (No pain) to 10 (Worst pain imaginable). Higher scores indicate better health-related quality of life. Two summary scores, a Global Physical Health score and a Global Mental Health score, can be derived from this instrument.
Changes from baseline pain intensity week 8	Baseline and post 8 week intervention	The intensity of pain is assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Intensity Adult Short Form 3a (v1.0). The instrument is a 3-item measure with the response scores ranging from 1 (Had no pain) to 5 (Very severe). Higher scores indicate higher pain intensity. The total raw score will be translated into a T-score for each participant for analysis.
Changes from baseline sleep quality at week 8	Baseline and post 8 week intervention	Sleep quality is assessed using the NIH PROMIS Sleep Disturbance Adult Short Form 8a, which contains 8 items on a 5-point Likert scale, ranging from 1 (Very much) to 5 (Not at all). The form has raw scores range from 8 to 40, with higher scores indicating worst sleep quality. The total raw score will be translated into a T-score for each participant for analysis.
Exercise enjoyment at week 8	Post 8 week intervention	Exercise enjoyment is assessed using Physical Activity Enjoyment Scale. The Physical Activity Enjoyment Scale contains 8 items, with higher score indicates greater exercise enjoyment.
Changes from baseline pain interference at week 8	Baseline and post 8 week intervention	The influence of pain on performing daily activities is assessed with the NIH PROMIS Pain Interference Adult Short Form 8a (v1.0), which contains 8 items with 5 response options ranging from 1 (Not at all) to 5 (Very much). The form has raw scores range from 8 to 40, with higher scores indicating more pain interference. The total raw score will be translated into a T-score for each participant for analysis.
Changes from baseline fatigue level at week 8	Baseline and post 8 week intervention	Fatigue is measured using the NIH PROMIS Fatigue Adult Short Form. The instrument is a 8 items on a 5-point Likert scale, ranging from 1 (Not at all/Never) to 5 (Very much/Always). Higher scores indicate higher fatigue. The total raw score is translated into a T-score for each participant for analysis.
Changes from baseline ability to participate in social roles and activities at week 8	Baseline and post 8 week intervention	Social participation is measured using the NIH PROMIS Ability to Participate in Social Roles and Activities Short Form 8a. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.

Trial Locations

Locations (1)

RecTech Center; 🇺🇸 Birmingham, Alabama, United States