Study on Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients

NCT05878145 | Completed

• 1 other identifier: SCI REHAB EXERCISE RCT
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

In the case of spinal cord injury, patients have shown a passive attitude towards participating in leisure sports or exercise programs, and there is a lack of suitable guidelines or experience in the local community for coaching exercise and sports for spinal cord injury patients, which makes coaches feel burdened when coaching these patients. Therefore, in this study, a suitable comprehensive exercise program will be designed and prescribed for patients who reside in the local community and want to participate in leisure sports, and the effectiveness and safety of the program will be verified. Based on the results, the aim of the study is to provide evidence that spinal cord injury patients can exercise safely and confidently in the local community in the future.

Conditions

Spinal Cord Injuries; Rehabilitation; Exercise Program

Outcome Measures

Primary Outcomes (2)

• EuroQol 5 Dimension 5 Level

  Self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Converting the patient's response results using quality weights has a value between 0.000 and 1.000. A higher score means a higher quality of life.

  Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

• 6 minute walk distance

  Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.

  Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

Secondary Outcomes (12)

• Spinal cord independence measure III

  Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

• Berg balance scale

  Baseline evaluation and follow-up evaluation after average 2 months of exercise program

• Timed up and go test

  Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

• Grip strength

  Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

• 30 second sit to stand test

  Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

Study Arms (2)

Intervention group

EXPERIMENTAL

A 20-session structured rehabilitation exercise program in those with spinal cord injuries

Behavioral: Structured rehabilitation exercise program

Control group

NO INTERVENTION

No exercise intervention in those with spinal cord injuries

Interventions

Structured rehabilitation exercise program BEHAVIORAL

Stretching (10 mins): neck, shoulder, wrist, back; Aerobic exercise (20 mins): cycle ergometer, wheelchair run; Strengthening exercise (15 mins): shoulder press, chest press, front raise, biceps curl, lateral raise, bent over rowing or rowing, bent over lateral raise, triceps extension; Balance training (5 mins); Stretching exercise (10 mins)

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Spinal cord injury patients who are 19 years old or above and residing in the local community
• A person who can walk independently for more than 10 meters without assistance from others

You may not qualify if:

• Individuals who have difficulty understanding the exercise program or expressing their symptoms
• Individuals who cannot participate in the intervention exercise program due to serious cardiovascular diseases
• Individuals who are deemed unsuitable for this study by a specialist in rehabilitation medicine due to other medical conditions

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Related Publications (1)

• Huh S, Kim Y, Ko HY, Yun MS, Shin YI, Lee JL, Ko SH. Effectiveness of a Community-Based Exercise Program for Ambulatory Individuals With Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Apr;106(4):481-490. doi: 10.1016/j.apmr.2024.11.003. Epub 2024 Nov 21.

  PMID: 39577713 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

Study Officials

• Sung-Hwa Ko, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 26, 2023
• Study Start: May 27, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)