StrokeCEPSNCT05616858
Complex Exercise Program for Stroke Patients
A study testing Complex exercise program in people with Stroke and Sports Physical Therapy, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Sports Physical Therapy, Program, Communication
- What is being tested?
- Complex exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Mar 2022to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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 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.
- Conditions
- Stroke, Sports Physical Therapy, Program, Communication
- Being tested
- Complex exercise program
- Medical subject headings
- Stroke, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex exercise programBehavioural
Stretching exercise, aerobic exercise, strengthening and balancing exercise
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group with exercise program Receives: Behavioral: Complex exercise program |
| Control group | No intervention | Group without exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
Maximal VO2 from cardiopulmonary exercise test
Measured: Baseline evaluation
Peak VO2
Maximal VO2 from cardiopulmonary exercise test
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary outcomes (32)
Functional ambulation category (0-5, the higher the better)
6-point functional walking test that evaluates ambulation ability
Measured: Baseline evaluation
Functional ambulation category (0-5, the higher the better)
6-point functional walking test that evaluates ambulation ability
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
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 evaluation
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: Follow-up evaluation (through study completion, an average of 6 weeks)
Timed up and go
To determine fall risk and measure the progress of balance
Measured: Baseline evaluation
Timed up and go
To determine fall risk and measure the progress of balance
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Grip strength
measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Measured: Baseline evaluation
Grip strength
measure of muscular strength or the maximum force/tension generated by one's forearm muscles
Measured: 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
Measured: Baseline evaluation
6-minute walk test
practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Figure-of-eight walk test
Measurement tool that assesses the ability to walk on a curved path
Measured: Baseline evaluation
Figure-of-eight walk test
Measurement tool that assesses the ability to walk on a curved path
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Sit-and-reach test
Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles
Measured: Baseline evaluation
Sit-and-reach test
Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Chair sit-to-stand test
Testing leg strength and endurance in older adults
Measured: Baseline evaluation
Chair sit-to-stand test
Testing leg strength and endurance in older adults
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Fugl-Meyer assessment (0-226, the higher the better)
Stroke-specific, performance-based impairment index
Measured: Baseline evaluation
Fugl-Meyer assessment (0-226, the higher the better)
Stroke-specific, performance-based impairment index
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Manual function test (0-32, the higher the better)
Evaluate unilateral manual performance in hemiparetic patients after stroke
Measured: Baseline evaluation
Manual function test (0-32, the higher the better)
Evaluate unilateral manual performance in hemiparetic patients after stroke
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline evaluation
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
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
Body composition analysis
Percentage of fat, bone, and muscle in the body
Measured: Baseline evaluation
Body composition analysis
Percentage of fat, bone, and muscle in the body
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
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
Measured: Baseline evaluation
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
Measured: 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)
A brief and simple instrument measuring health related quality of life
Measured: Baseline evaluation
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: Follow-up evaluation (through study completion, an average of 6 weeks)
Getriatic depression scale (0-15, the higher the more depressive)
Assessment of depression in the elderly
Measured: Baseline evaluation
Getriatic depression scale (0-15, the higher the more depressive)
Assessment of depression in the elderly
Measured: Follow-up evaluation (through study completion, an average of 6 weeks)
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 evaluation
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: 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 posted15 Nov 2022
- Study start18 Mar 2022
- Primary completion31 Dec 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label, case-control study
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT05616858
- Sponsor's protocol ID
- PNUYH_ETRI_2
- Acronym
- CEPS
- Status last verified
- Feb 2023
- First submitted
- 31 Oct 2022
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community
- ClinicalTrials.gov ID
- NCT05616858
- Acronym / sponsor ID
- CEPS / PNUYH_ETRI_2
- Conditions
- Stroke, Sports Physical Therapy, Program, Communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Nov 2022 (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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label, case-control study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Complex exercise programGroup with exercise program |
| Control group | No intervention | –Group without exercise program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- MMSE less than 18
- BBS less than 41
- Severe aphagia who cannot communicate
- Severe cardiovascular conditions inhibiting exercise programs
- Musculoskeletal problems inhibiting exercise programs
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 |
|---|---|---|
| Complex exercise programStretching exercise, aerobic exercise, strengthening and balancing exercise | Behavioural | Intervention group |
Primary outcome
Peak VO2
Time frame: Baseline evaluation
Maximal VO2 from cardiopulmonary exercise test
Peak VO2
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Maximal VO2 from cardiopulmonary exercise test
32 secondary outcomes
Functional ambulation category (0-5, the higher the better)
Time frame: Baseline evaluation
Functional ambulation category (0-5, the higher the better)
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Berg balance scale (0-56, the higher the better)
Time frame: Baseline evaluation
Berg balance scale (0-56, the higher the better)
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Timed up and go
Time frame: Baseline evaluation
Timed up and go
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Grip strength
Time frame: Baseline evaluation
Grip strength
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
6-minute walk test
Time frame: Baseline evaluation
6-minute walk test
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Figure-of-eight walk test
Time frame: Baseline evaluation
Figure-of-eight walk test
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Sit-and-reach test
Time frame: Baseline evaluation
Sit-and-reach test
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Chair sit-to-stand test
Time frame: Baseline evaluation
Chair sit-to-stand test
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Fugl-Meyer assessment (0-226, the higher the better)
Time frame: Baseline evaluation
Fugl-Meyer assessment (0-226, the higher the better)
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Manual function test (0-32, the higher the better)
Time frame: Baseline evaluation
Manual function test (0-32, the higher the better)
Time frame: 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
Modified Barthel Index (Korean version) (0-100, the higher the better)
Time frame: Follow-up evaluation (through study completion, an average of 6 weeks)
Body composition analysis
Time frame: Baseline evaluation
Body composition analysis
Time frame: 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
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)
Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
Time frame: 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)
Getriatic depression scale (0-15, the higher the more depressive)
Time frame: 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)
International Physical Activity Questionnaire (No scores)
Time frame: Baseline evaluation
International Physical Activity Questionnaire (No scores)
Time frame: 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 15 Aug 2023.
- Individual participant dataSharing planned: No
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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 Complex exercise program in people with Stroke and Sports Physical Therapy, 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 15 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 Sung-Hwa Ko, PhD (+82-10-9344-4117, ijsh6679@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: Baseline evaluation). The study lists 2 primary outcomes in all. 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 15 Aug 2023.