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

NCT ID: NCT05878145

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-27
• Study Completion Date: 2024-03-31

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.

Detailed Description

Spinal cord injury is classified into complete paralysis and incomplete paralysis depending on the degree of spinal cord damage. In the case of complete paralysis, functional recovery is almost impossible, but in the case of incomplete paralysis, the level of functional recovery is determined through active rehabilitation exercises. In the past, most spinal cord injuries were traumatic, but due to the decrease in accidents, traumatic spinal cord injuries have decreased, and the incidence of non-traumatic spinal cord injuries (spinal cord disorders) has increased significantly due to aging. Most people with spinal cord injuries have difficulty performing appropriate rehabilitation exercises in the local community due to mobility impairments and limitations in daily activities. Spinal cord injury patients who participate in existing disabled sports are limited to some (relatively young) patients who have received epilepsy diagnosis. Individualized rehabilitation exercises based on each patient's personalized protocol are necessary, and sufficient functional recovery can be achieved through this approach. It is predicted that rehabilitation exercises through a protocol will improve cardiac and respiratory function and quality of life. Rehabilitation exercises for spinal cord injury patients should be applied based on accurate evaluation of function, and assessment of exercise-related risk factors should also be conducted. Customized exercise programs based on individual exercise function evaluations should be applied, but currently there is a lack of rehabilitation exercise programs that consider this. Additionally, risk factor evaluations related to exercise are not being conducted. Therefore, the development and application of patient-tailored community-based rehabilitation exercise programs for spinal cord injury patients that include risk factor evaluations and functional assessments are necessary.

Conditions

Spinal Cord Injuries; Rehabilitation; Exercise Program

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Structured rehabilitation exercise program

Intervention Type: 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)

Control group

No exercise intervention in those with spinal cord injuries

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Structured rehabilitation exercise program

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sungchul Huh

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sung-Hwa Ko, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 39577713 (View on PubMed)

Other Identifiers

SCI REHAB EXERCISE RCT

Identifier Type: -

Identifier Source: org_study_id