Complex Exercise Program for Stroke Patients (CEPS)

August 13, 2023 updated by: Sung-Hwa Ko, Pusan National University Yangsan Hospital

Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community

The physical and social effects of exercise programs and daily exercise have already been demonstrated in stroke. However, stroke survivors have shown a passive attitude towards the exercise program and there was little guideline and experience of the stroke exercise program in the community. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.

Study Overview

Status

Status

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

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.

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 (Estimated)

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.
100

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
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Community indwelling stroke patients discharged from Pusan National University Yangsan Hospital
  • Independent ambulator (FAC over 4)
  • Independent daily activities (Modified Rankin Scale less than 2)
  • No apparent spasticity on hemiplegic side (Modified Ashworth scale less than 1)
  • Hemiplegic side motor grades (Manual muscle testing, MMT) more than 3

Exclusion Criteria:

  • MMSE less than 18
  • BBS less than 41
  • Severe aphagia who cannot communicate
  • Severe cardiovascular conditions inhibiting exercise programs
  • Musculoskeletal problems inhibiting exercise programs
  • Other medical conditions considered by physiatrists

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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
Group with exercise program
Behavioral: Complex exercise program
Stretching exercise, aerobic exercise, strengthening and balancing exercise
No Intervention: Control group
Group without exercise program

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
Peak VO2
Time Frame: Baseline evaluation
Maximal VO2 from cardiopulmonary exercise test
Baseline evaluation
Peak VO2
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Maximal VO2 from cardiopulmonary exercise test
Follow-up evaluation (through study completion, an average of 6 weeks)

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
Timed up and go
Time Frame: Baseline evaluation
To determine fall risk and measure the progress of balance
Baseline evaluation
Grip strength
Time Frame: Baseline evaluation
measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Baseline evaluation
6-minute walk test
Time Frame: Baseline evaluation
practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Baseline evaluation
Figure-of-eight walk test
Time Frame: Baseline evaluation
Measurement tool that assesses the ability to walk on a curved path
Baseline evaluation
Sit-and-reach test
Time Frame: Baseline evaluation
Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles
Baseline evaluation
Chair sit-to-stand test
Time Frame: Baseline evaluation
Testing leg strength and endurance in older adults
Baseline evaluation
Body composition analysis
Time Frame: Baseline evaluation
Percentage of fat, bone, and muscle in the body
Baseline evaluation
Functional ambulation category (0-5, the higher the better)
Time Frame: Baseline evaluation
6-point functional walking test that evaluates ambulation ability
Baseline evaluation
Functional ambulation category (0-5, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
6-point functional walking test that evaluates ambulation ability
Follow-up evaluation (through study completion, an average of 6 weeks)
Berg balance scale (0-56, the higher the better)
Time Frame: Baseline evaluation
Objectively determine a patient's ability to safely balance during a series of predetermined tasks
Baseline evaluation
Berg balance scale (0-56, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Objectively determine a patient's ability to safely balance during a series of predetermined tasks
Follow-up evaluation (through study completion, an average of 6 weeks)
Timed up and go
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
To determine fall risk and measure the progress of balance
Follow-up evaluation (through study completion, an average of 6 weeks)
Grip strength
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Follow-up evaluation (through study completion, an average of 6 weeks)
6-minute walk test
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Follow-up evaluation (through study completion, an average of 6 weeks)
Figure-of-eight walk test
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Measurement tool that assesses the ability to walk on a curved path
Follow-up evaluation (through study completion, an average of 6 weeks)
Sit-and-reach test
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles
Follow-up evaluation (through study completion, an average of 6 weeks)
Chair sit-to-stand test
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Testing leg strength and endurance in older adults
Follow-up evaluation (through study completion, an average of 6 weeks)
Fugl-Meyer assessment (0-226, the higher the better)
Time Frame: Baseline evaluation
Stroke-specific, performance-based impairment index
Baseline evaluation
Fugl-Meyer assessment (0-226, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Stroke-specific, performance-based impairment index
Follow-up evaluation (through study completion, an average of 6 weeks)
Manual function test (0-32, the higher the better)
Time Frame: Baseline evaluation
Evaluate unilateral manual performance in hemiparetic patients after stroke
Baseline evaluation
Manual function test (0-32, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Evaluate unilateral manual performance in hemiparetic patients after stroke
Follow-up evaluation (through study completion, an average of 6 weeks)
Modified Barthel Index (Korean version) (0-100, the higher the better)
Time Frame: Baseline evaluation
Measure of physical disability used widely to assess behaviour relating to activities of daily living
Baseline evaluation
Modified Barthel Index (Korean version) (0-100, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Measure of physical disability used widely to assess behaviour relating to activities of daily living
Follow-up evaluation (through study completion, an average of 6 weeks)
Body composition analysis
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Percentage of fat, bone, and muscle in the body
Follow-up evaluation (through study completion, an average of 6 weeks)
Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)
Time Frame: Baseline evaluation
Screening of dementia and to investigate the possible changes of optimal cutoff scores
Baseline evaluation
Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Screening of dementia and to investigate the possible changes of optimal cutoff scores
Follow-up evaluation (through study completion, an average of 6 weeks)
Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
Time Frame: Baseline evaluation
A brief and simple instrument measuring health related quality of life
Baseline evaluation
Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
A brief and simple instrument measuring health related quality of life
Follow-up evaluation (through study completion, an average of 6 weeks)
Getriatic depression scale (0-15, the higher the more depressive)
Time Frame: Baseline evaluation
Assessment of depression in the elderly
Baseline evaluation
Getriatic depression scale (0-15, the higher the more depressive)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Assessment of depression in the elderly
Follow-up evaluation (through study completion, an average of 6 weeks)
International Physical Activity Questionnaire (No scores)
Time Frame: Baseline evaluation
27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old
Baseline evaluation
International Physical Activity Questionnaire (No scores)
Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)
27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old
Follow-up evaluation (through study completion, an average of 6 weeks)

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

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.
March 18, 2022

Primary Completion (Estimated)

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.
December 31, 2023

Study Completion (Estimated)

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.
December 31, 2023

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).
October 31, 2022

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.
November 7, 2022

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.
November 15, 2022

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.
August 15, 2023

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.
August 13, 2023

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.
February 1, 2023

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.
  • PNUYH_ETRI_2

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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