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Community-based Complex Exercise for Stroke Patients (COB-CEPS)

Primary Purpose

Stroke, Exercise

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

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria: Stroke patients aged 30 years or older residing in the community Those who can walk independently and have a score of 3 or higher in the Functional Ambulation Category (FAC) The daily life dependence of the stroke patient is a person who can perform simple tasks necessary for daily life, Those who scored 2 points or less on the Modified Rankin Scale (mRS) Subjects with no or mild stiffness of the affected upper and lower limbs, with a score of 1 or less on the Modified Ashworth Scale (MAS) All 3 major joints of the affected upper and lower limbs (Manual Muscle Test (MMT)) are 3 points (F grade) or higher ruler Exclusion Criteria: With moderate or severe cognitive dysfunction, Korean-Mini Mental state test (Korean-Mini Mental state test) Those who scored less than 18 points in the Examination (K-MMSE) A person with a moderate or higher fall risk and less than 41 points on the Berg Balance Scale (BBS) Those who have difficulty understanding the intervention exercise program or expressing symptoms due to severe language impairment Those who cannot apply this intervention exercise program due to serious cardiovascular disease Those who have musculoskeletal disorders that make it impossible to exercise Those who are judged unsuitable for this study under the judgment of a specialist in rehabilitation medicine due to other diseases

Sites / Locations

  • Pusan National University Yangsan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Daily life group

Arm Description

Outcomes

Primary Outcome Measures

6WMT
6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians

Secondary Outcome Measures

MRS
modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability The scale runs from 0-6, running from perfect health without symptoms to death.
BBS
Berg balance scale (0-56, the higher the better) Objectively determine a patient's ability to safely balance during a series of predetermined tasks
FAC
Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability
MMT
Manual Muscle Testing (MMT) is a technique used in physical therapy and rehabilitation to assess the strength and function of individual muscles or muscle groups. It involves the application of specific resistance against the muscle's movement to determine its ability to generate force. This technique includes assessing major muscles from the upper and lower limbs opposing the therapist's force and grading the patient's muscle strength on a 0 to 5 scale
TUG
Timed up and go To determine fall risk and measure the progress of balance
Grip Strength
Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Body composition
Percentage of fat, bone, and muscle in the body
Physical activity
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
EQ-5D
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
GDS
Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly
sit to stand
Recording the number of times sitting and rising for 30 seconds by measuring the strength of the lower extremities of the elderly
flexibility test
Measure the length beyond the tip of the toes with the hand stretched out in a seated forward bending position.
coordination test
Assessment of Coordination Measures in Older Adults. Draw a rectangle with a width of 3.6m and a length of 1.6m, place a chair at a point 2.4m from the center in both corners, and measure the time to return to the left and right rear corners twice in 0.1 second units

Full Information

First Posted
August 6, 2023
Last Updated
August 19, 2023
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06012396
Brief Title
Community-based Complex Exercise for Stroke Patients
Acronym
COB-CEPS
Official Title
Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
November 30, 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
Yes

5. Study Description

Brief Summary
A lot of physical and social effects of exercise programs and daily physical education have already been proven for stroke patients after discharge. However, stroke patients have shown a passive attitude in participating in physical education or exercise programs for life, and the local community lacked appropriate guidelines or experience in guiding exercise and physical education for stroke patients, so they had a burden on instructing exercise. In this study, an appropriate complex exercise program was established for patients after discharge through analysis of domestic and foreign research data to provide an environment and opportunity to exercise in the community, and based on the results, stroke patients actively exercise in the community in the future. The goal is to provide a basis for doing so.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
rct
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Daily life group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Stoke complex exercise program
Intervention Description
warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle main exercise(40min) aerobic exercise(20min)- use stepper, treadmill, high intensity HRR60%, RPE 11~14 low intensity HRR30%, RPE 9~11 repeated interval training strength and balance exercises(20min)- program1. upper(shoulder press, chest press, biceps curl), lower(hip flexion, knee extension), Core(plank exercise, sit up) program2. upper(seated back row, triceps extension), lower(hip extension, hip abduction, knee flexion, Core(superman exercise, bridge exercise) repeated ever other day program1, program2 clean-up(5min) - same as warm-up
Primary Outcome Measure Information:
Title
6WMT
Description
6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Outcome Measure Information:
Title
MRS
Description
modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability The scale runs from 0-6, running from perfect health without symptoms to death.
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
BBS
Description
Berg balance scale (0-56, the higher the better) Objectively determine a patient's ability to safely balance during a series of predetermined tasks
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
FAC
Description
Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability
Time Frame
visit 1, visit 23
Title
MMT
Description
Manual Muscle Testing (MMT) is a technique used in physical therapy and rehabilitation to assess the strength and function of individual muscles or muscle groups. It involves the application of specific resistance against the muscle's movement to determine its ability to generate force. This technique includes assessing major muscles from the upper and lower limbs opposing the therapist's force and grading the patient's muscle strength on a 0 to 5 scale
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
TUG
Description
Timed up and go To determine fall risk and measure the progress of balance
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Grip Strength
Description
Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Body composition
Description
Percentage of fat, bone, and muscle in the body
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
Physical activity
Description
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
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
EQ-5D
Description
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
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
GDS
Description
Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
sit to stand
Description
Recording the number of times sitting and rising for 30 seconds by measuring the strength of the lower extremities of the elderly
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
flexibility test
Description
Measure the length beyond the tip of the toes with the hand stretched out in a seated forward bending position.
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Title
coordination test
Description
Assessment of Coordination Measures in Older Adults. Draw a rectangle with a width of 3.6m and a length of 1.6m, place a chair at a point 2.4m from the center in both corners, and measure the time to return to the left and right rear corners twice in 0.1 second units
Time Frame
Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stroke patients aged 30 years or older residing in the community Those who can walk independently and have a score of 3 or higher in the Functional Ambulation Category (FAC) The daily life dependence of the stroke patient is a person who can perform simple tasks necessary for daily life, Those who scored 2 points or less on the Modified Rankin Scale (mRS) Subjects with no or mild stiffness of the affected upper and lower limbs, with a score of 1 or less on the Modified Ashworth Scale (MAS) All 3 major joints of the affected upper and lower limbs (Manual Muscle Test (MMT)) are 3 points (F grade) or higher ruler Exclusion Criteria: With moderate or severe cognitive dysfunction, Korean-Mini Mental state test (Korean-Mini Mental state test) Those who scored less than 18 points in the Examination (K-MMSE) A person with a moderate or higher fall risk and less than 41 points on the Berg Balance Scale (BBS) Those who have difficulty understanding the intervention exercise program or expressing symptoms due to severe language impairment Those who cannot apply this intervention exercise program due to serious cardiovascular disease Those who have musculoskeletal disorders that make it impossible to exercise Those who are judged unsuitable for this study under the judgment of a specialist in rehabilitation medicine due to other diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JUNGLIM LEE
Phone
82+ 1049147899
Ext
82+ 0553604152
Email
lim6668@naver.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
Undecided

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Community-based Complex Exercise for Stroke Patients

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