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Active, Not Recruiting

NCT Number: NCT06524453

Exercise Program for Individuals With SCI in Community

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Exercise Program Nervous System Diseases Rehabilitation Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

  • 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

Treatment and study plan

Wheelchair accessible exercise program

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

Primary outcomes

  1. 6 minute push test

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

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

Secondary outcomes

  1. Spinal cord independence measure III

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

    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.

  2. Modified functional reach test

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

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

  3. Grip strength

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

    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.

  4. Arm curl

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

    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.

  5. Back scratch test

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

    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).

  6. Beck anxiety inventory

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

    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.

  7. Beck depression inventory

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

    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.

  8. Fat-free mass from bioelectrical impedance analysis

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

    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.

  9. Fat-free mass index from bioelectrical impedance analysis

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

    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.

  10. Percent body fat from bioelectrical impedance analysis

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

    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.

  11. skeletal muscle mass from bioelectrical impedance analysis

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

    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.

  12. EuroQol 5 Dimension 5 Level

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

    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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Individuals With Spinal Cord Injury in Community: A Randomized Controlled Trials

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
May 29, 2025

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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