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Not yet recruiting NCT07725952

Cardiovascular Autonomic Function After Resistance Training

No phase Interventional Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Upper-Limb Resistance Training.
Who it may be relevant to
Registry conditions: Spinal Cord Injury. Basic parameters: 19 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of 8-Week Resistance Training on Cardiovascular Autonomic Function in Spinal Cord Injury

Overview

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

  • Behavioral Upper-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.

Primary outcome measures

  • Heart Rate Variability [Time frame: Baseline and Week 8]
  • Baroreflex Sensitivity [Time frame: Baseline and Week 8]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Pusan National University Yangsan Hospital — Yangsan

Identifiers

NCT: NCT07725952 · 11-2026-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗