Exercise Program for Individuals With SCI in Community
NCT Number: NCT06524453
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Spinal Cord Injuries|Exercise Program|Rehabilitation
Interventions: BEHAVIORAL: Wheelchair accessible exercise program
Sponsor: Pusan National University Yangsan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-03-31
Locations: Pusan National University Yangsan Hospital, Yangsan, Gyeongnam, 50612, Korea, Republic of

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.

Primary Outcome Measures: 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|5 minute wheelchair running, 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 Outcome Measures: 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months 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 2 months of exercise program