StrokeCOB-CEPSNCT06012396
Community-based Complex Exercise for Stroke Patients
A study testing Stoke complex exercise program in people with Stroke and Exercise, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- What is being tested?
- Stoke complex exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
Sung-Hwa Ko, PhD, +82-10-9344-4117, ijsh6679@gmail.com
About this study
Official title: Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients
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.
- Being tested
- Stoke complex exercise program
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stoke complex exercise programBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Behavioral: Stoke complex exercise program |
| Daily life group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
6WMT
6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary outcomes (13)
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.
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
FAC
Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability
Measured: visit 1, visit 23
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
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
TUG
Timed up and go To determine fall risk and measure the progress of balance
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Grip Strength
Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Body composition
Percentage of fat, bone, and muscle in the body
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
GDS
Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
flexibility test
Measure the length beyond the tip of the toes with the hand stretched out in a seated forward bending position.
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start6 Mar 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- rct
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung-Hwa Ko, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012396
- Sponsor's protocol ID
- PNUYH_ETRI_3
- Acronym
- COB-CEPS
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients
- ClinicalTrials.gov ID
- NCT06012396
- Acronym / sponsor ID
- COB-CEPS / PNUYH_ETRI_3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- rct
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Stoke complex exercise program |
| Daily life group | No intervention | – |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stoke complex exercise program1. warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle 2. 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 | Behavioural | Exercise group |
Primary outcome
6WMT
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
13 secondary outcomes
MRS
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
BBS
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
FAC
Time frame: visit 1, visit 23
MMT
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
TUG
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Grip Strength
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Body composition
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Physical activity
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
EQ-5D
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
GDS
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
sit to stand
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
flexibility test
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
coordination test
Time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stoke complex exercise program in people with Stroke and Exercise, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JUNGLIM LEE (82+ 1049147899 ext. 82+ 0553604152, lim6668@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6WMT (time frame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.