NCT07725952

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

July 21, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

July 27, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 24, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 21, 2026

Last Update Submit

July 21, 2026

Conditions

Keywords

Spinal Cord InjuryResistance TrainingCardiovascular Autonomic FunctionHeart Rate VariabilityBaroreflex SensitivityOrthostatic HypotensionExercise Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • Heart Rate Variability

    Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.

    Baseline and Week 8

  • Baroreflex Sensitivity

    Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.

    Baseline and Week 8

Secondary Outcomes (4)

  • Orthostatic Hypotension

    Baseline and Week 8

  • Grip Strength

    Baseline and Week 8

  • Orthostatic Hypotension Symptoms (ADFSCI)

    Baseline and Week 8

  • Quality of Life (WHOQOL-BREF)

    Baseline and Week 8

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Behavioral: Upper-Limb Resistance Training

Control group

NO INTERVENTION

Participants will continue their usual daily activities without participating in the resistance training program during the 8-week study period.

Interventions

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.

Exercise group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

MeSH Terms

Conditions

Spinal Cord InjuriesHypotension, Orthostatic

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesOrthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Sungchul Huh, MD, PhD

    Pusan National University Yangsan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dogyu Lee, M.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 24, 2026

Study Start

July 27, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 24, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations