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NCT Number: NCT07725952

Cardiovascular Autonomic Function After Resistance Training

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.

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Key information

Conditions

Spinal Cord Injury Autonomic Nervous System Diseases Cardiovascular Diseases Central Nervous System Diseases Hypotension Hypotension, Orthostatic Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Upper-Limb Resistance Training

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Orthostatic Hypotension

    Time frame: 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.

  2. Grip Strength

    Time frame: Baseline and Week 8

    Grip strength will be measured using a hand dynamometer to evaluate changes in upper-limb muscle strength following the intervention.

  3. Orthostatic Hypotension Symptoms (ADFSCI)

    Time frame: 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.

  4. Quality of Life (WHOQOL-BREF)

    Time frame: Baseline and Week 8

    Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Dogyu Lee, M.S.

CONTACT

[email protected]

055-360-1730

Yuna Kim, B.S.

CONTACT

[email protected]

055-360-1730

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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