- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07725952
Cardiovascular Autonomic Function After Resistance Training
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dogyu Lee, M.S.
- Phone Number: 055-360-1730
- Email: 2doq2doq@gmail.com
Study Contact Backup
- Name: Yuna Kim, B.S.
- Phone Number: 055-360-1730
- Email: kyoona1289@gmail.com
Study Locations
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, South Korea, 50612
- Pusan national university yangsan hospital
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Contact:
- Dogyu Lee, M.S.
- Phone Number: 055-360-1730
- Email: 2doq2doq@gmail.com
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Contact:
- Yuna Kim, B.S.
- Phone Number: 055-360-1730
- Email: kyoona1289@gmail.com
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Principal Investigator:
- Sungchul Huh, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
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.
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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.
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No Intervention: Control group
Participants will continue their usual daily activities without participating in the resistance training program during the 8-week study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline and Week 8
|
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Baroreflex Sensitivity
Time Frame: Baseline and Week 8
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Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Orthostatic Hypotension
Time Frame: Baseline and Week 8
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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.
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Baseline and Week 8
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Grip Strength
Time Frame: Baseline and Week 8
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Grip strength will be measured using a hand dynamometer to evaluate changes in upper-limb muscle strength following the intervention.
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Baseline and Week 8
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Orthostatic Hypotension Symptoms (ADFSCI)
Time Frame: Baseline and Week 8
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Orthostatic hypotension-related symptoms will be assessed using the orthostatic hypotension items of the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) questionnaire.
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Baseline and Week 8
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Quality of Life (WHOQOL-BREF)
Time Frame: Baseline and Week 8
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Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.
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Baseline and Week 8
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Collaborators and Investigators
Investigators
- Principal Investigator: Sungchul Huh, MD, PhD, Pusan national university yangsan hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-2026-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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