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Complex Exercise Program for Stroke Patients (CEPS)

Primary Purpose

Stroke, Sports Physical Therapy, Program, Communication

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Complex exercise program
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Group with exercise program

Group without exercise program

Outcomes

Primary Outcome Measures

Peak VO2
Maximal VO2 from cardiopulmonary exercise test
Peak VO2
Maximal VO2 from cardiopulmonary exercise test

Secondary Outcome Measures

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

Full Information

First Posted
October 31, 2022
Last Updated
August 13, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05616858
Brief Title
Complex Exercise Program for Stroke Patients
Acronym
CEPS
Official Title
Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Sports Physical Therapy, Program, Communication

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open-label, case-control study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group with exercise program
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Group without exercise program
Intervention Type
Behavioral
Intervention Name(s)
Complex exercise program
Intervention Description
Stretching exercise, aerobic exercise, strengthening and balancing exercise
Primary Outcome Measure Information:
Title
Peak VO2
Description
Maximal VO2 from cardiopulmonary exercise test
Time Frame
Baseline evaluation
Title
Peak VO2
Description
Maximal VO2 from cardiopulmonary exercise test
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Outcome Measure Information:
Title
Functional ambulation category (0-5, the higher the better)
Description
6-point functional walking test that evaluates ambulation ability
Time Frame
Baseline evaluation
Title
Functional ambulation category (0-5, the higher the better)
Description
6-point functional walking test that evaluates ambulation ability
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Berg balance scale (0-56, the higher the better)
Description
Objectively determine a patient's ability to safely balance during a series of predetermined tasks
Time Frame
Baseline evaluation
Title
Berg balance scale (0-56, the higher the better)
Description
Objectively determine a patient's ability to safely balance during a series of predetermined tasks
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Timed up and go
Description
To determine fall risk and measure the progress of balance
Time Frame
Baseline evaluation
Title
Timed up and go
Description
To determine fall risk and measure the progress of balance
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Grip strength
Description
measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Time Frame
Baseline evaluation
Title
Grip strength
Description
measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
6-minute walk test
Description
practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Time Frame
Baseline evaluation
Title
6-minute walk test
Description
practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Figure-of-eight walk test
Description
Measurement tool that assesses the ability to walk on a curved path
Time Frame
Baseline evaluation
Title
Figure-of-eight walk test
Description
Measurement tool that assesses the ability to walk on a curved path
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Sit-and-reach test
Description
Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles
Time Frame
Baseline evaluation
Title
Sit-and-reach test
Description
Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Chair sit-to-stand test
Description
Testing leg strength and endurance in older adults
Time Frame
Baseline evaluation
Title
Chair sit-to-stand test
Description
Testing leg strength and endurance in older adults
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Fugl-Meyer assessment (0-226, the higher the better)
Description
Stroke-specific, performance-based impairment index
Time Frame
Baseline evaluation
Title
Fugl-Meyer assessment (0-226, the higher the better)
Description
Stroke-specific, performance-based impairment index
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Manual function test (0-32, the higher the better)
Description
Evaluate unilateral manual performance in hemiparetic patients after stroke
Time Frame
Baseline evaluation
Title
Manual function test (0-32, the higher the better)
Description
Evaluate unilateral manual performance in hemiparetic patients after stroke
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Modified Barthel Index (Korean version) (0-100, the higher the better)
Description
Measure of physical disability used widely to assess behaviour relating to activities of daily living
Time Frame
Baseline evaluation
Title
Modified Barthel Index (Korean version) (0-100, the higher the better)
Description
Measure of physical disability used widely to assess behaviour relating to activities of daily living
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Body composition analysis
Description
Percentage of fat, bone, and muscle in the body
Time Frame
Baseline evaluation
Title
Body composition analysis
Description
Percentage of fat, bone, and muscle in the body
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)
Description
Screening of dementia and to investigate the possible changes of optimal cutoff scores
Time Frame
Baseline evaluation
Title
Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)
Description
Screening of dementia and to investigate the possible changes of optimal cutoff scores
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
Description
A brief and simple instrument measuring health related quality of life
Time Frame
Baseline evaluation
Title
Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
Description
A brief and simple instrument measuring health related quality of life
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Getriatic depression scale (0-15, the higher the more depressive)
Description
Assessment of depression in the elderly
Time Frame
Baseline evaluation
Title
Getriatic depression scale (0-15, the higher the more depressive)
Description
Assessment of depression in the elderly
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)
Title
International Physical Activity Questionnaire (No scores)
Description
27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old
Time Frame
Baseline evaluation
Title
International Physical Activity Questionnaire (No scores)
Description
27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old
Time Frame
Follow-up evaluation (through study completion, an average of 6 weeks)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung-Hwa Ko, PhD
Phone
+82-10-9344-4117
Email
ijsh6679@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sungchul Huh
Phone
+82-1093542177
Email
dr.huhsc@gmail.com
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeongnam
ZIP/Postal Code
50612
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Hwa Ko, PhD
Phone
+82-10-9344-4117
Email
ijsh6679@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Complex Exercise Program for Stroke Patients

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