Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Resistance Training, Cardiovascular Autonomic Function, Heart Rate Variability, Baroreflex Sensitivity, Orthostatic Hypotension, Exercise Rehabilitation
Brief 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). 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.
Interventions
BEHAVIORALUpper-Limb Resistance Training
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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate Variability | Baseline and Week 8 | Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention. |
| Baroreflex Sensitivity | Baseline and Week 8 | Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic Hypotension | Baseline and Week 8 | 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. |
| Grip Strength | Baseline and Week 8 | Grip strength will be measured using a hand dynamometer to evaluate changes in upper-limb muscle strength following the intervention. |
| Orthostatic Hypotension Symptoms (ADFSCI) | Baseline and Week 8 | Orthostatic hypotension-related symptoms will be assessed using the orthostatic hypotension items of the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) questionnaire. |
| Quality of Life (WHOQOL-BREF) | Baseline and Week 8 | Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. |
Countries
South Korea
Contacts
CONTACTDogyu Lee, M.S.
CONTACTYuna Kim, B.S.
PRINCIPAL_INVESTIGATORSungchul Huh, MD, PhD
Pusan National University Yangsan Hospital
Outcome results
None listed