Cardiovascular Autonomic Function After Resistance Training
ConditionSpinal Cord Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-85
SponsorPusan National University Yangsan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Upper-Limb Resistance Training
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Exercise groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Heart Rate Variability
Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Time frame
Baseline and Week 82
Baroreflex Sensitivity
Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Time frame
Baseline and Week 8Secondary outcomes
1
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.
Time frame
Baseline and Week 82
Grip Strength
Grip strength will be measured using a hand dynamometer to evaluate changes in upper-limb muscle strength following the intervention.
Time frame
Baseline and Week 83
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.
Time frame
Baseline and Week 84
Quality of Life (WHOQOL-BREF)
Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.
Time frame
Baseline and Week 8Sponsors and contacts
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Source ClinicalTrials.gov
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