Spinal Cord InjuriesNCT06524453
Exercise Program for Individuals With SCI in Community
A study testing Wheelchair accessible exercise program in people with Spinal Cord Injuries and Exercise Program, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Exercise Program, Rehabilitation
- What is being tested?
- Wheelchair accessible exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2024to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
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
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Exercise Program, Rehabilitation
- Being tested
- Wheelchair accessible exercise program
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair accessible exercise programBehavioural
- Stretching exercise
- Dynamic and static
- Neck, shoulder, elbow, wrist, trunk
- 10 minutes
- Aerobic exercise
- High intensity interval training
- Arm ergometer or wheelchair running
- 20 mins
- Strengthening exercise
- Shoulder and chest, elbow joint major muscle; shoulder and trunk stabilization exercise
- 3 sets of 10
- 20 minutes
- Stretching exercise
- Dynamic and static
- Neck, shoulder, elbow, wrist, trunk
- 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | A 20-session structured rehabilitation exercise program for individuals with SCI Receives: Behavioral: Wheelchair accessible exercise program |
| Control group | No intervention | Maintain their daily lives without any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute push test
Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.
Measured: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024
- Primary completion3 Feb 2025
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sung-Hwa Ko, PhD, Study chair, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524453
- Sponsor's protocol ID
- SCI exercise RCT
- Status last verified
- Oct 2024
- First submitted
- 23 Jul 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06524453
- Acronym / sponsor ID
- SCI exercise RCT
- Conditions
- Spinal Cord Injuries, Exercise Program, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Wheelchair accessible exercise programA 20-session structured rehabilitation exercise program for individuals with SCI |
| Control group | No intervention | –Maintain their daily lives without any intervention |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheelchair accessible exercise program1. Stretching exercise * Dynamic and static * Neck, shoulder, elbow, wrist, trunk * 10 minutes 2. Aerobic exercise * High intensity interval training * Arm ergometer or wheelchair running * 20 mins 3. Strengthening exercise * Shoulder and chest, elbow joint major muscle; shoulder and trunk stabilization exercise * 3 sets of 10 * 20 minutes 4. Stretching exercise * Dynamic and static * Neck, shoulder, elbow, wrist, trunk * 10 minutes | Behavioural | Exercise group |
Primary outcome
6 minute push test
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.
12 secondary outcomes
Spinal cord independence measure III
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Modified functional reach test
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Grip strength
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Arm curl
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Back scratch test
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Beck anxiety inventory
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Beck depression inventory
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Fat-free mass from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Fat-free mass index from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Percent body fat from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
skeletal muscle mass from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
EuroQol 5 Dimension 5 Level
Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Hwa Ko, PhD study chair
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair accessible exercise program in people with Spinal Cord Injuries and Exercise Program, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute push test (time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.