Spinal Cord InjuryNCT07725952
Cardiovascular Autonomic Function After Resistance Training
A study testing Upper-Limb Resistance Training in people with Spinal Cord Injury, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
The purpose of this clinical trial is to evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Upper-Limb Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2026to 31 Dec 2026
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided written informed consent and agreed to participate in the study.
- Adults aged 19 to 85 years.
- Chronic spinal cord injury (SCI) of traumatic or non-traumatic etiology, at least 6 months after injury.
- Cervical or thoracic spinal cord injury.
- Classified as American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C, or D.
- Sufficient upper-limb range of motion to perform resistance training.
- Elbow extensor muscle strength of Manual Muscle Test (MMT) grade 3 or higher.
Who cannot join
- Presence of any serious medical condition that would preclude participation in the study.
- Inability to understand or perform the exercise program.
- Uncontrolled diabetes mellitus or progressive neurological disease.
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg).
- History of cardiovascular disease within the past 6 months.
- Current use of medications that may affect heart rate variability (HRV) or baroreflex sensitivity (BRS).
- Severe orthostatic hypotension (OH) or autonomic dysreflexia (AD).
- Considered unsuitable for participation in the study by a board-certified specialist in Physical and Rehabilitation Medicine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Dogyu Lee, M.S., 055-360-1730, 2doq2doq@gmail.com
Yuna Kim, B.S., 055-360-1730, kyoona1289@gmail.com
About this study
Official title: Effects of 8-Week Resistance Training on Cardiovascular Autonomic Function in Spinal Cord Injury
The purpose of this clinical trial is to evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic spinal cord injury (SCI). The primary objectives are to determine whether upper-limb resistance training improves heart rate variability (HRV) and baroreflex sensitivity (BRS), and whether it improves blood pressure responses during postural change, upper-limb strength, symptoms related to orthostatic hypotension, and quality of life.
Participants will be randomly assigned to either the resistance training group or the control group. All participants will complete assessments before and after the 8-week study period, including measurements of HRV, BRS, blood pressure responses during a tilt-table test, hand grip strength, and questionnaires assessing orthostatic hypotension symptoms and quality of life. Participants assigned to the resistance training group will participate in supervised upper-limb resistance training three times per week for 8 weeks.
Read the detailed description
SCI can impair cardiovascular autonomic function by disrupting the neural pathways that regulate heart rate and blood pressure. As a result, many individuals with SCI experience cardiovascular autonomic dysfunction, including orthostatic hypotension, which may increase cardiovascular health risks.
Although exercise is recommended for people with SCI, previous studies have mainly focused on aerobic exercise and have demonstrated inconsistent effects on cardiovascular autonomic function. Upper-limb resistance training is widely used in rehabilitation to improve strength and functional independence, but its effects on autonomic function have not been well established.
This randomized controlled trial will evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic SCI. The study will assess changes in HRV and BRS, while also exploring changes in orthostatic blood pressure responses, upper-limb strength, orthostatic hypotension symptoms, and quality of life. The findings may provide evidence supporting upper-limb resistance training as a rehabilitation strategy to improve cardiovascular autonomic function in individuals with chronic SCI.
- Conditions
- Spinal Cord Injury
- Being tested
- Upper-Limb Resistance Training
- Keywords
- Spinal Cord Injury, Resistance Training, Cardiovascular Autonomic Function, Heart Rate Variability, Baroreflex Sensitivity, Orthostatic Hypotension, Exercise Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper-Limb Resistance TrainingBehavioural
Participants will perform a supervised upper-limb resistance training program three times per week for 8 weeks. Each session will last approximately 30 minutes and consist of progressive resistance exercises for the upper extremities. Exercise intensity will be progressively adjusted according to each participant's tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants will receive a supervised upper-limb resistance training program three times per week for 8 weeks. The program consists of progressive resistance exercises for the upper extremities. Receives: Behavioral: Upper-Limb Resistance Training |
| Control group | No intervention | Participants will continue their usual daily activities without participating in the resistance training program during the 8-week study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Measured: Baseline and Week 8
Baroreflex Sensitivity
Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Measured: Baseline and Week 8
Secondary outcomes (4)
Orthostatic Hypotension
Orthostatic hypotension will be assessed by changes in systolic and diastolic blood pressure (ΔSBP and ΔDBP) during postural change using a tilt table. Orthostatic hypotension will be defined as a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg.
Measured: Baseline and Week 8
Grip Strength
Grip strength will be measured using a hand dynamometer to evaluate changes in upper-limb muscle strength following the intervention.
Measured: Baseline and Week 8
Orthostatic Hypotension Symptoms (ADFSCI)
Orthostatic hypotension-related symptoms will be assessed using the orthostatic hypotension items of the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) questionnaire.
Measured: Baseline and Week 8
Quality of Life (WHOQOL-BREF)
Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.
Measured: Baseline and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- None (open label)
- Enrolment
- 20 participants (estimated)
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
- Sungchul Huh, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725952
- Sponsor's protocol ID
- 11-2026-006
- Status last verified
- Sep 2026
- First submitted
- 21 Jul 2026
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 8-Week Resistance Training on Cardiovascular Autonomic Function in Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07725952
- Acronym / sponsor ID
- 11-2026-006
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Resistance Training, Cardiovascular Autonomic Function, Heart Rate Variability, Baroreflex Sensitivity, Orthostatic Hypotension, Exercise Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (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.
The purpose of this clinical trial is to evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic spinal cord injury (SCI). The primary objectives are to determine whether upper-limb resistance training improves heart rate variability (HRV) and baroreflex sensitivity (BRS), and whether it improves blood pressure responses during postural change, upper-limb strength, symptoms related to orthostatic hypotension, and quality of life.
Participants will be randomly assigned to either the resistance training group or the control group. All participants will complete assessments before and after the 8-week study period, including measurements of HRV, BRS, blood pressure responses during a tilt-table test, hand grip strength, and questionnaires assessing orthostatic hypotension symptoms and quality of life. Participants assigned to the resistance training group will participate in supervised upper-limb resistance training three times per week for 8 weeks.
Detailed description
SCI can impair cardiovascular autonomic function by disrupting the neural pathways that regulate heart rate and blood pressure. As a result, many individuals with SCI experience cardiovascular autonomic dysfunction, including orthostatic hypotension, which may increase cardiovascular health risks.
Although exercise is recommended for people with SCI, previous studies have mainly focused on aerobic exercise and have demonstrated inconsistent effects on cardiovascular autonomic function. Upper-limb resistance training is widely used in rehabilitation to improve strength and functional independence, but its effects on autonomic function have not been well established.
This randomized controlled trial will evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic SCI. The study will assess changes in HRV and BRS, while also exploring changes in orthostatic blood pressure responses, upper-limb strength, orthostatic hypotension symptoms, and quality of life. The findings may provide evidence supporting upper-limb resistance training as a rehabilitation strategy to improve cardiovascular autonomic function in individuals with chronic SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Upper-Limb Resistance TrainingParticipants will receive a supervised upper-limb resistance training program three times per week for 8 weeks. The program consists of progressive resistance exercises for the upper extremities. |
| Control group | No intervention | –Participants will continue their usual daily activities without participating in the resistance training program during the 8-week study period. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provided written informed consent and agreed to participate in the study.
- Adults aged 19 to 85 years.
- Chronic spinal cord injury (SCI) of traumatic or non-traumatic etiology, at least 6 months after injury.
- Cervical or thoracic spinal cord injury.
- Classified as American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C, or D.
Key exclusion criteria (8 listed)
- Presence of any serious medical condition that would preclude participation in the study.
- Inability to understand or perform the exercise program.
- Uncontrolled diabetes mellitus or progressive neurological disease.
- Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg).
- History of cardiovascular disease within the past 6 months.
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 |
|---|---|---|
| Upper-Limb Resistance TrainingParticipants will perform a supervised upper-limb resistance training program three times per week for 8 weeks. Each session will last approximately 30 minutes and consist of progressive resistance exercises for the upper extremities. Exercise intensity will be progressively adjusted according to each participant's tolerance. | Behavioural | Exercise group |
Primary outcome
Heart Rate Variability
Time frame: Baseline and Week 8
Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Baroreflex Sensitivity
Time frame: Baseline and Week 8
Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
4 secondary outcomes
Orthostatic Hypotension
Time frame: Baseline and Week 8
Grip Strength
Time frame: Baseline and Week 8
Orthostatic Hypotension Symptoms (ADFSCI)
Time frame: Baseline and Week 8
Quality of Life (WHOQOL-BREF)
Time frame: Baseline and Week 8
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 3 Sep 2026.
- 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.
Sungchul Huh, MD, 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 Upper-Limb Resistance Training in people with Spinal Cord Injury, 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 3 Sep 2026. 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?
Contact Dogyu Lee, M.S. (055-360-1730, 2doq2doq@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Baseline and Week 8). 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?
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 3 Sep 2026.