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Active, not recruitingNCT06524453Updated May 29, 2025

Exercise Program for Individuals With SCI in Community

An interventional study of Wheelchair accessible exercise program in Spinal Cord Injuries, Exercise Program and Rehabilitation, sponsored by Pusan National University Yangsan Hospital. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-29.

Sponsored by Pusan National University Yangsan Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study summary

Patients with spinal cord injury (SCI) who have reduced mobility have difficulty exercising on their own without proper guidance in the community. Community-based exercise programs are effective in removing various barriers such as lack of exercise programs, lack of experts, and lack of facilities. This study aims to verify the effectiveness and safety of a systematically designed customized exercise program for patients who live in the community and want to participate in exercise. Our study results will serve as a basis for creating an environment where more individuals with SCI can continue to exercise proactively and in the long term.

Read the detailed description

People with SCI must perform regular exercise to improve function, quality of life, and reduce medical costs. However, SCI people with reduced mobility have difficulty exercising on their own without proper guidance in the community. Rehabilitation exercise for SCI people should be applied based on accurate functional assessment, and risk factors related to exercise should also be assessed. Community-based exercise programs are effective in removing various barriers such as lack of exercise programs, lack of experts, and lack of facilities.

This study aims to verify the effectiveness and safety of a systematically designed customized exercise program for SCI people who live in the community and want to participate in exercise. Based on the results of many previous studies, the investigators expect that program participants will have improved cardiopulmonary endurance and quality of life. Our study results will serve as a basis for creating an environment where more people with SCI can continue to exercise preemptively and in the long term.

02

Conditions studied

  • Spinal Cord Injuries
  • Exercise Program
  • Rehabilitation
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's planned enrollment of 58 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Spinal cord injury patients who are 19-65 years old or above and residing in the local community
  • Individuals who can not walk independently for more than 10 meters without assistance from others
  • Individuals whose elbow extensor strength is greater than muscle manual test (MMT) Fair

Exclusion criteria

Exclusion Criteria:

  • Individuals who have difficulty understanding the exercise program or expressing their symptoms
  • Individuals who cannot participate in the intervention exercise program due to serious cardiovascular diseases
  • Individuals who are deemed unsuitable for this study by a specialist in rehabilitation medicine due to other medical conditions
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (estimated)

Study arms

  • Experimental
    Exercise group

    A 20-session structured rehabilitation exercise program for individuals with SCI

    Behavioral: Wheelchair accessible exercise program

  • No intervention
    Control group

    Maintain their daily lives without any intervention

Interventions

  • BehavioralWheelchair accessible exercise program

    1. Stretching exercise * Dynamic and static * Neck, shoulder, elbow, wrist, trunk * 10 minutes 2. Aerobic exercise * High intensity interval training * Arm ergometer or wheelchair running * 20 mins 3. Strengthening exercise * Shoulder and chest, elbow joint major muscle; shoulder and trunk stabilization exercise * 3 sets of 10 * 20 minutes 4. Stretching exercise * Dynamic and static * Neck, shoulder, elbow, wrist, trunk * 10 minutes

06

What researchers measure

Primary outcomes

  1. 6 minute push test

    Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

Secondary outcomes

  1. Spinal cord independence measure III

    Tool to evaluate independence of spinal cord injury patients. The total score ranges from 0 to 100, and the higher the score, the more independent the patient is.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  2. Modified functional reach test

    Assessing balance in sitting posture. Measures the maximum distance a person can extend forward while sitting in a fixed posture.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  3. Grip strength

    Force applied by the hand to pull on or suspend from objects. It is widely used to assess sarcopenia and as a surrogate indicator of muscle strength. Measured in kg, the higher the value, the stronger the grip is considered.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  4. Arm curl

    Tests upper limb endurance. Measures the number of times a participant can hold a dumbbell (4kg for men, 2kg for women) for 2 minutes and fully bend and straighten their arms. The higher the number, the better the function and strength.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  5. Back scratch test

    Measures how close the hands can be brought together behind the back. If the fingertips touch then the score is zero. If they do not touch, measure the distance between the finger tips (a negative score), if they overlap, measure by how much (a positive score).

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  6. Beck anxiety inventory

    Anxiety measuring tool. Each item is scored 0-3 points, with a total score of 0-63 points. A score of 0-7 indicates minimal anxiety, a score of 8-15 indicates mild anxiety, a score of 16-25 indicates moderate anxiety, and a score of 26-63 indicates severe anxiety.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  7. Beck depression inventory

    Depression measuring tool. Each item is scord 0-3 points, with a total score of 0-63 points. A score of 0-13 indicates minimal depression, a score of 14-19 indicates mild depression, a score of 20-28 indicates moderate depression, and a score of 29-63 indicates severe depression.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  8. Fat-free mass from bioelectrical impedance analysis

    A method used to measure the components of the body. It is the total amount (kg) of body components excluding body fat, and the higher it is, the better the body composition is interpreted.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  9. Fat-free mass index from bioelectrical impedance analysis

    A method used to measure components of the body. This is an indicator that standardizes fat-free mass according to body size. The higher it is, the more muscle mass and the better health.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  10. Percent body fat from bioelectrical impedance analysis

    A method used to measure the components of the body. The normal range varies depending on age and gender. The lower the score within the general normal range, the better the health. The higher it is, the higher the risk of obesity related diseases.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  11. skeletal muscle mass from bioelectrical impedance analysis

    A method used to measure the components of the body. Normal range varies depending on age and gender. The higher it is within the general normal range, the better the health. The lower it is, the higher the risk of lack of strength and sarcopenia.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

  12. EuroQol 5 Dimension 5 Level

    Self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Converting the patient's response results using quality weights has a value between 0.000 and 1.000. A higher score means a higher quality of life.

    Time frame: Baseline evaluation and follow-up evaluation immediately after average 8-weeks of exercise program

07

Study locations

1 site
  • Pusan National University Yangsan Hospital
    Yangsan, Gyeongnam 50612, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06524453
Lead sponsor
Pusan National University Yangsan Hospital
Responsible party
Sponsor
First posted
Jul 29, 2024
Start date
Aug 1, 2024
Primary completion
Feb 3, 2025
Completion
Aug 31, 2025 (estimated)
Last update
May 29, 2025

Study contacts

Sung-Hwa Ko, PhD
study chair · Pusan National University Yangsan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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