Spinal Cord InjuriesNCT05878145
Study on Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
A study testing Structured rehabilitation exercise program in people with Spinal Cord Injuries and Rehabilitation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Rehabilitation, Exercise Program
- What is being tested?
- Structured rehabilitation exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2023to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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 Community-based Spinal Cord Injury Patients
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Rehabilitation, Exercise Program
- Being tested
- Structured rehabilitation 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.
Structured rehabilitation exercise programBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | A 20-session structured rehabilitation exercise program in those with spinal cord injuries Receives: Behavioral: Structured rehabilitation exercise program |
| Control group | No intervention | No exercise intervention in those with spinal cord injuries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Baseline evaluation and follow-up evaluation immediately after average 2 months 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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (-).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline evaluation and follow-up evaluation immediately after average 2 months 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 posted26 May 2023
- Study start27 May 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sungchul Huh, Pusan National University Yangsan Hospital
- Investigators
- Sung-Hwa Ko, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878145
- Sponsor's protocol ID
- SCI REHAB EXERCISE RCT
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huh S, Kim Y, Ko HY, Yun MS, Shin YI, Lee JL, Ko SH. Effectiveness of a Community-Based Exercise Program for Ambulatory Individuals With Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Apr;106(4):481-490. doi: 10.1016/j.apmr.2024.11.003. Epub 2024 Nov 21.
PubMed 39577713
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. 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 Community-based Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT05878145
- Acronym / sponsor ID
- SCI REHAB EXERCISE RCT
- Conditions
- Spinal Cord Injuries, Rehabilitation, Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 27 May 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 May 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Structured rehabilitation exercise programA 20-session structured rehabilitation exercise program in those with spinal cord injuries |
| Control group | No intervention | –No exercise intervention in those with spinal cord injuries |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Structured rehabilitation exercise programStretching (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) | Behavioural | Intervention group |
Primary outcome
EuroQol 5 Dimension 5 Level
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
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.
6 minute walk distance
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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 2 months of exercise program
Berg balance scale
Time frame: Baseline evaluation and follow-up evaluation after average 2 months of exercise program
Timed up and go test
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Grip strength
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
30 second sit to stand test
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Sit and reach test
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Beck anxiety inventory
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Beck depression inventory
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Fat-free mass from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Fat-free mass index from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation after average 2 months of exercise program
Percent body fat from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
skeletal muscle mass from bioelectrical impedance analysis
Time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 39577713Huh S, Kim Y, Ko HY, Yun MS, Shin YI, Lee JL, Ko SH. Effectiveness of a Community-Based Exercise Program for Ambulatory Individuals With Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2025 Apr;106(4):481-490. doi: 10.1016/j.apmr.2024.11.003. Epub 2024 Nov 21.
- 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 principal investigator
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 Structured rehabilitation exercise program in people with Spinal Cord Injuries and Rehabilitation, 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 2 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: finished, as of the sponsor's last update on 4 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EuroQol 5 Dimension 5 Level (time frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878145, which also lists 1 linked publication.
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 4 Jun 2024.