Exercise Program for Individuals With SCI in Community

Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Individuals With Spinal Cord Injury in Community: A Randomized Controlled Trials

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rehabilitation; Spinal Cord Injuries; Exercise Program
• Intervention / Treatment: Behavioral: Wheelchair accessible exercise program

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.

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeongnam
    • Yangsan, Gyeongnam, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group; A 20-session structured rehabilitation exercise program for individuals with SCI	Behavioral: Wheelchair accessible exercise program; Stretching exerciseDynamic and staticNeck, shoulder, elbow, wrist, trunk10 minutes; Aerobic exerciseHigh intensity interval trainingArm ergometer or wheelchair running20 mins; Strengthening exerciseShoulder and chest, elbow joint major muscle; shoulder and trunk stabilization exercise3 sets of 1020 minutes; Stretching exerciseDynamic and staticNeck, shoulder, elbow, wrist, trunk10 minutes
No Intervention: Control group; Maintain their daily lives without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal cord independence measure III	Tool to evaluate independence of spinal cord injury patients. The total score ranges from 0 to 100, and the higher the score, the more independent the patient is.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Modified functional reach test	Assessing balance in sitting posture. Measures the maximum distance a person can extend forward while sitting in a fixed posture.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Grip strength	Force applied by the hand to pull on or suspend from objects. It is widely used to assess sarcopenia and as a surrogate indicator of muscle strength. Measured in kg, the higher the value, the stronger the grip is considered.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Arm curl	Tests upper limb endurance. Measures the number of times a participant can hold a dumbbell (4kg for men, 2kg for women) for 2 minutes and fully bend and straighten their arms. The higher the number, the better the function and strength.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Back scratch test	Measures how close the hands can be brought together behind the back. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (a negative score), if they overlap, measure by how much (a positive score).	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Beck anxiety inventory	Anxiety measuring tool. Each item is scored 0-3 points, with a total score of 0-63 points. A score of 0-7 indicates minimal anxiety, a score of 8-15 indicates mild anxiety, a score of 16-25 indicates moderate anxiety, and a score of 26-63 indicates severe anxiety.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Beck depression inventory	Depression measuring tool. Each item is scord 0-3 points, with a total score of 0-63 points. A score of 0-13 indicates minimal depression, a score of 14-19 indicates mild depression, a score of 20-28 indicates moderate depression, and a score of 29-63 indicates severe depression.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Fat-free mass from bioelectrical impedance analysis	A method used to measure the components of the body. It is the total amount (kg) of body components excluding body fat, and the higher it is, the better the body composition is interpreted.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Fat-free mass index from bioelectrical impedance analysis	A method used to measure components of the body. This is an indicator that standardizes fat-free mass according to body size. The higher it is, the more muscle mass and the better health.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Percent body fat from bioelectrical impedance analysis	A method used to measure the components of the body. The normal range varies depending on age and gender. The lower the score within the general normal range, the better the health. The higher it is, the higher the risk of obesity related diseases.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
skeletal muscle mass from bioelectrical impedance analysis	A method used to measure the components of the body. Normal range varies depending on age and gender. The higher it is within the general normal range, the better the health. The lower it is, the higher the risk of lack of strength and sarcopenia.	Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
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 8-weeks of exercise program

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital
• Investigators: Study Chair: Sung-Hwa Ko, PhD, Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): February 3, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: SCI exercise RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No