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

June 2, 2024 updated by: Sungchul Huh, Pusan National University Yangsan Hospital

Study on the Safety and Effectiveness of a Rehabilitation Exercise Program for Community-based Spinal Cord Injury Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Spinal cord injury patients who are 19 years old or above and residing in the local community
  • A person who can walk independently for more than 10 meters without assistance from others

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
EuroQol 5 Dimension 5 Level
Time Frame: Baseline evaluation and follow-up evaluation immediately 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. 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
6 minute walk distance
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Sub-maximal exercise test used to assess aerobic capacity and endurance. Longer distances indicate better athletic ability.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Spinal cord independence measure III
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Berg balance scale
Time Frame: Baseline evaluation and follow-up evaluation after average 2 months of exercise program
Testing tool with high validity and reliability used to measure balance. Each item is scored 0-4 points, with a total score of 0-56 points. A higher score means better balance ability.
Baseline evaluation and follow-up evaluation after average 2 months of exercise program
Timed up and go test
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Reliable and valid test for quantifying functional mobility. The time it takes for a patient to get up from a chair, walk 3 meters, and come back to sit down is measured. The shorter the time, the better the mobility.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Grip strength
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
30 second sit to stand test
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Testing leg strength and endurance. It measures the number of times a person can stand up from a chair and sit down again in 30 seconds, and the higher the number, the better function and strength.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Sit and reach test
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Test to measure hamstring and low back flexibility. It is expressed in centimeters (cm), and if the fingertips touch in front of the toes, it is recorded as a positive number (+), and if the fingertips touch behind the toes, it is recorded as a negative number (-).
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Beck anxiety inventory
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Beck depression inventory
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Depression measuring tool. Each item is scored 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Fat-free mass from bioelectrical impedance analysis
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
Fat-free mass index from bioelectrical impedance analysis
Time Frame: Baseline evaluation and follow-up evaluation after average 2 months 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.
Baseline evaluation and follow-up evaluation after average 2 months of exercise program
Percent body fat from bioelectrical impedance analysis
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program
skeletal muscle mass from bioelectrical impedance analysis
Time Frame: Baseline evaluation and follow-up evaluation immediately after average 2 months 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.
Baseline evaluation and follow-up evaluation immediately after average 2 months of exercise program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pusan National University Yangsan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sung-Hwa Ko, PhD, Pusan National University Yangsan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCI REHAB EXERCISE RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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