Clinical trial NCT06524453: Exercise Program for Individuals With SCI in Community
Official title: Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Individuals With Spinal Cord Injury in Community: A Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Exercise Program
Rehabilitation
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 58
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 6 minute push test
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Secondary outcomes:
measure: Spinal cord independence measure III
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Modified functional reach test
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Grip strength
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Arm curl
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Back scratch test
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Beck anxiety inventory
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Beck depression inventory
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Fat-free mass from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Fat-free mass index from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: Percent body fat from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: skeletal muscle mass from bioelectrical impedance analysis
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
measure: EuroQol 5 Dimension 5 Level
timeFrame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks 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: STUDY_CHAIR
References: