An interventional study of Structured rehabilitation exercise program in Spinal Cord Injuries, Rehabilitation and Exercise Program, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,950 studies on the registry are indexed under Spinal Cord Injuries; 507 are open to participants now.
This study's enrollment of 57 is above the median of 24 across 1,567 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
A 20-session structured rehabilitation exercise program in those with spinal cord injuries
Behavioral: Structured rehabilitation exercise program
No exercise intervention in those with spinal cord injuries
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)
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.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
6 minute walk distance
Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
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.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Berg balance scale
Testing tool with high validity and reliability used to measure balance. Each item is scored 0-4 points, with a total score of 0-56 points. A higher score means better balance ability.
Time frame: Baseline evaluation and follow-up evaluation after average 2 months of exercise program
Timed up and go test
Reliable and valid test for quantifying functional mobility. The time it takes for a patient to get up from a chair, walk 3 meters, and come back to sit down is measured. The shorter the time, the better the mobility.
Time frame: 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.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
30 second sit to stand test
Testing leg strength and endurance. It measures the number of times a person can stand up from a chair and sit down again in 30 seconds, and the higher the number, the better function and strength.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Sit and reach test
Test to measure hamstring and low back flexibility. It is expressed in centimeters (cm), and if the fingertips touch in front of the toes, it is recorded as a positive number (+), and if the fingertips touch behind the toes, it is recorded as a negative number (-).
Time frame: 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.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Beck depression inventory
Depression measuring tool. Each item is scored 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline evaluation and follow-up evaluation 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.
Time frame: 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.
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
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Pusan National University Yangsan Hospital