Spinal Cord Injuries
Conditions
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.
Interventions
OTHERMovement-to-Music
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.
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor will be blinded to participants' group assignments throughout the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Level at Week 8 | Post 8-week intervention | Physical activity was 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 minutes people with spinal cord injury spend in mild, moderate, and heavy intensity leisure time physical activity in the last 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Week 8 | Post 8-week intervention | The pain intensity was 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). The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. Higher scores indicate higher pain intensity. |
| Pain Interference at Week 8 | Post 8-week intervention | The influence of pain on performing daily activities was assessed with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS®) Pain Interference Adult Short Form 8a (v1.0). The form 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 is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. |
| Sleep Quality at Week 8 | Post 8 week intervention | Sleep quality is assessed using the NIH Patient-Reported Outcomes Measurement Information System (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 is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. |
| Fatigue Level at Week 8 | Post 8-week intervention | Fatigue was measured using the NIH Patient-Reported Outcomes Measurement Information System (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 converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. |
| Health-related Physical Quality of Life at Week 8 | Post 8-week intervention | Health-related quality of life was assessed using the NIH Patient-Reported Outcomes Measurement Information System (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. The total raw score is converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis. |
| Ability to Participate in Social Roles and Activities at Week 8 | Post 8-week intervention | Social participation was measured using the NIH Patient-Reported Outcomes Measurement Information System (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 converted to a T-score (population mean=50, SD=10) using standard scoring guidelines for each participant for analysis.each participant for analysis. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited through social media platforms (e.g., Instagram, Facebook) and word of mouth. Recruitment for the Feasibility Phase took place between February 2021 and March 2022. Recruitment for the Effectiveness Phase occurred between August 2023 and September 2024. Recruitment and enrollment for both study phases were performed separately.
Pre-assignment details
In the Feasibility Phase, the 36 enrolled participants were randomized to 3 groups: M2M, SET, and AC. For the Effectiveness Phase, the M2M arm was dropped after interim analysis and the 60 enrolled participants were randomized to 2 groups: SET and AC.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 49.5 Years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 30 | 0 / 30 |
Outcome results
None listed