Exercise Program for Individuals With SCI in Community

NCT ID: NCT06524453

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2025-08-31

Brief Summary

Patients with spinal cord injury (SCI) who have reduced mobility have difficulty exercising on their own without proper guidance in the community. Community-based exercise programs are effective in removing various barriers such as lack of exercise programs, lack of experts, and lack of facilities. This study aims to verify the effectiveness and safety of a systematically designed customized exercise program for patients who live in the community and want to participate in exercise. Our study results will serve as a basis for creating an environment where more individuals with SCI can continue to exercise proactively and in the long term.

Detailed Description

People with SCI must perform regular exercise to improve function, quality of life, and reduce medical costs. However, SCI people with reduced mobility have difficulty exercising on their own without proper guidance in the community. Rehabilitation exercise for SCI people should be applied based on accurate functional assessment, and risk factors related to exercise should also be assessed. Community-based exercise programs are effective in removing various barriers such as lack of exercise programs, lack of experts, and lack of facilities.

This study aims to verify the effectiveness and safety of a systematically designed customized exercise program for SCI people who live in the community and want to participate in exercise. Based on the results of many previous studies, the investigators expect that program participants will have improved cardiopulmonary endurance and quality of life. Our study results will serve as a basis for creating an environment where more people with SCI can continue to exercise preemptively and in the long term.

Conditions

Spinal Cord Injuries; Exercise Program; Rehabilitation

Study Design

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

Study Groups

Exercise group

A 20-session structured rehabilitation exercise program for individuals with SCI

Group Type: EXPERIMENTAL

Wheelchair accessible exercise program

Intervention Type: BEHAVIORAL

1. Stretching exercise

• Dynamic and static
• Neck, shoulder, elbow, wrist, trunk
• 10 minutes

2. Aerobic exercise

• High intensity interval training
• Arm ergometer or wheelchair running
• 20 mins

3. Strengthening exercise

• Shoulder and chest, elbow joint major muscle; shoulder and trunk stabilization exercise
• 3 sets of 10
• 20 minutes

4. Stretching exercise

• Dynamic and static
• Neck, shoulder, elbow, wrist, trunk
• 10 minutes

Control group

Maintain their daily lives without any intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wheelchair accessible exercise program

1. Stretching exercise

• Dynamic and static
• Neck, shoulder, elbow, wrist, trunk
• 10 minutes

2. Aerobic exercise

• High intensity interval training
• Arm ergometer or wheelchair running
• 20 mins

3. Strengthening exercise

• Shoulder and chest, elbow joint major muscle; shoulder and trunk stabilization exercise
• 3 sets of 10
• 20 minutes

4. Stretching exercise

• Dynamic and static
• Neck, shoulder, elbow, wrist, trunk
• 10 minutes

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Spinal cord injury patients who are 19-65 years old or above and residing in the local community
• Individuals who can not walk independently for more than 10 meters without assistance from others
• Individuals whose elbow extensor strength is greater than muscle manual test (MMT) Fair

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
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sung-Hwa Ko, PhD

Role: STUDY_CHAIR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Countries

South Korea

Other Identifiers

SCI exercise RCT

Identifier Type: -

Identifier Source: org_study_id