Study on Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients

Sponsor
Pusan National University Yangsan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05878145
Collaborator
(none)
115
2
7

Study Details

Study Description

Brief Summary

In the case of spinal cord injury, patients have shown a passive attitude towards participating in leisure sports or exercise programs, and there is a lack of suitable guidelines or experience in the local community for coaching exercise and sports for spinal cord injury patients, which makes coaches feel burdened when coaching these patients. Therefore, in this study, a suitable comprehensive exercise program will be designed and prescribed for patients who reside in the local community and want to participate in leisure sports, and the effectiveness and safety of the program will be verified. Based on the results, the aim of the study is to provide evidence that spinal cord injury patients can exercise safely and confidently in the local community in the future.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Structured rehabilitation exercise program
N/A

Detailed Description

Spinal cord injury is classified into complete paralysis and incomplete paralysis depending on the degree of spinal cord damage. In the case of complete paralysis, functional recovery is almost impossible, but in the case of incomplete paralysis, the level of functional recovery is determined through active rehabilitation exercises. In the past, most spinal cord injuries were traumatic, but due to the decrease in accidents, traumatic spinal cord injuries have decreased, and the incidence of non-traumatic spinal cord injuries (spinal cord disorders) has increased significantly due to aging. Most people with spinal cord injuries have difficulty performing appropriate rehabilitation exercises in the local community due to mobility impairments and limitations in daily activities. Spinal cord injury patients who participate in existing disabled sports are limited to some (relatively young) patients who have received epilepsy diagnosis. Individualized rehabilitation exercises based on each patient's personalized protocol are necessary, and sufficient functional recovery can be achieved through this approach. It is predicted that rehabilitation exercises through a protocol will improve cardiac and respiratory function and quality of life. Rehabilitation exercises for spinal cord injury patients should be applied based on accurate evaluation of function, and assessment of exercise-related risk factors should also be conducted. Customized exercise programs based on individual exercise function evaluations should be applied, but currently there is a lack of rehabilitation exercise programs that consider this. Additionally, risk factor evaluations related to exercise are not being conducted. Therefore, the development and application of patient-tailored community-based rehabilitation exercise programs for spinal cord injury patients that include risk factor evaluations and functional assessments are necessary.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
115 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

A 20-session structured rehabilitation exercise program in those with spinal cord injuries

Behavioral: Structured rehabilitation exercise program
Stretching (10 mins): neck, shoulder, wrist, back; Aerobic exercise (20 mins): cycle ergometer, wheelchair run; Strengthening exercise (15 mins): shoulder press, chest press, front raise, biceps curl, lateral raise, bent over rowing or rowing, bent over lateral raise, triceps extension; Balance training (5 mins); Stretching exercise (10 mins)

No Intervention: Control group

No exercise intervention in those with spinal cord injuries

Outcome Measures

Primary Outcome Measures

  1. EuroQol 5 Dimension 5 Level [Evaluation after average 2 months of exercise program]

    Self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

  2. 6 minute walk distance [Evaluation after average 2 months of exercise program]

    Sub-maximal exercise test used to assess aerobic capacity and endurance

Secondary Outcome Measures

  1. Berg balance scale [Baseline evaluation and follow-up evaluation after average 2 months of exercise program]

    Testing tool with high validity and reliability used to measure balance

  2. Timed up and go test [Baseline evaluation and follow-up evaluation after average 2 months of exercise program]

    Reliable and valid test for quantifying functional mobility

  3. Grip strength [Baseline evaluation and follow-up evaluation after average 2 months of exercise program]

    Force applied by the hand to pull on or suspend from objects

  4. Sit to stand test [Baseline evaluation and follow-up evaluation after average 2 months of exercise program]

    Testing leg strength and endurance

  5. Sit and reach test [Baseline evaluation and follow-up evaluation after average 2 months of exercise program]

    Test to measure hamstring and low back flexibility

  6. Fat-free mass from bioelectrical impedance analysis [Baseline evaluation and follow-up evaluation after average 2 months of exercise program]

    A method used to measure the components of the body

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Spinal cord injury patients who are 19 years old or above and residing in the local community

  • A person who is unable to walk independently for more than 10 meters without assistance from others

  • A person whose elbow joint flexor muscle strength level is MMT 3 (Fair) or higher

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Pusan National University Yangsan Hospital

Investigators

  • Principal Investigator: Sung-Hwa Ko, PhD, Pusan National University Yangsan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sungchul Huh, Assistant professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier:
NCT05878145
Other Study ID Numbers:
  • SCI REHAB EXERCISE RCT
First Posted:
May 26, 2023
Last Update Posted:
May 26, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2023