Exercise Program for Individuals With SCI in Community

NCT06524453 | Active Not Recruiting

• 1 other identifier: SCI exercise RCT
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Exercise Program; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6 minute push test

  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 8-weeks of exercise program

Secondary Outcomes (12)

• Spinal cord independence measure III

  Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

• Modified functional reach test

  Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

• Grip strength

  Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

• Arm curl

  Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

• Back scratch test

  Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Behavioral: Wheelchair accessible exercise program

Control group

NO INTERVENTION

Maintain their daily lives without any intervention

Interventions

Wheelchair accessible exercise program 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

Exercise group

Eligibility Criteria

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

You may qualify if:

• Spinal cord injury patients who are 19-65 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

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

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

  STUDY CHAIR

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: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: February 3, 2025
• Study Completion: August 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)