Clinical trial NCT05878145: Study on Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
Official title: Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Rehabilitation
Exercise Program
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 57
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury patients who are 19 years old or above and residing in the local community
* A person who can walk independently for more than 10 meters without assistance from others

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

Primary outcomes:
measure: EuroQol 5 Dimension 5 Level
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: 6 minute walk distance
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Secondary outcomes:
measure: Spinal cord independence measure III
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Berg balance scale
timeFrame: Baseline evaluation and follow-up evaluation after average 2 months of exercise program
measure: Timed up and go test
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Grip strength
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: 30 second sit to stand test
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Sit and reach test
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Beck anxiety inventory
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Beck depression inventory
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Fat-free mass from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: Fat-free mass index from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation after average 2 months of exercise program
measure: Percent body fat from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
measure: skeletal muscle mass from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongnam
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sung-Hwa Ko, PhD
role: PRINCIPAL_INVESTIGATOR
References: