Spinal Cord Injury Program in Exercise

NCT03925077 | Completed Results

• 2 other identifiers: IRB-30000313390DPGE0005
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Physical Activity Level at Week 8

  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.

  Post 8-week intervention

Secondary Outcomes (6)

• Pain Intensity Week 8

  Post 8-week intervention

• Pain Interference at Week 8

  Post 8-week intervention

• Sleep Quality at Week 8

  Post 8 week intervention

• Fatigue Level at Week 8

  Post 8-week intervention

• Health-related Physical Quality of Life at Week 8

  Post 8-week intervention

Study Arms (5)

Phase 1: Movement-to-Music (M2M)

ACTIVE COMPARATOR

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.

Other: Movement-to-Music

Phase 1: Standard Exercise Training (SET)

ACTIVE COMPARATOR

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.

Other: Standard Exercise Training

Phase 1: Attention Control (AC)

NO INTERVENTION

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

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.

Other: Standard Exercise Training

Phase 2: Attention Control (AC)

NO INTERVENTION

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.

Interventions

Movement-to-Music OTHER

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.

Also known as: M2M

Phase 1: Movement-to-Music (M2M)

Standard Exercise Training OTHER

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.

Also known as: SET

Phase 1: Standard Exercise Training (SET); Phase 2: Standard Exercise Training (SET)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

RecTech Center

Birmingham, Alabama, 35209, United States

Location

Related Publications (1)

• 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.

  PMID: 34412653 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

Because the interventions were delivered asynchronously, it was challenging to verify whether participants consistently completed the exercises or engaged with the videos and articles. Maintaining long-term engagement after the intervention also proved challenging, highlighting the need for future research to identify factors contributing to attrition and to develop strategies that promote sustained participation.

Results Point of Contact

• Title: Hui-Ju Young
• Organization: University of Alabama at Birmingham

hjyoung@uab.edu

2059341168

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to participants' group assignments throughout the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 23, 2019
• Study Start: February 1, 2021
• Primary Completion: November 22, 2024
• Study Completion: March 31, 2025
• Last Updated: February 5, 2026
• Results First Posted: February 5, 2026

Record last verified: 2026-01

Locations

US (1)