Complex Exercise Program for Stroke Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Sports Physical Therapy, Program, Communication

Intervention / Treatment
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* Behavioral: Complex exercise program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, open-label, case-control study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Group with exercise program | Behavioral: Complex exercise program<br>* Stretching exercise, aerobic exercise, strengthening and balancing exercise<br>|
| No Intervention: Control group<br>Group without exercise program | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional ambulation category (0-5, the higher the better) | 6-point functional walking test that evaluates ambulation ability | Baseline evaluation | 
| Functional ambulation category (0-5, the higher the better) | 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) | 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) | 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 | To determine fall risk and measure the progress of balance | Baseline evaluation | 
| Timed up and go | To determine fall risk and measure the progress of balance | 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 | Baseline evaluation | 
| Grip strength | 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 | practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians | Baseline evaluation | 
| 6-minute walk test | 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 | Measurement tool that assesses the ability to walk on a curved path | Baseline evaluation | 
| Figure-of-eight walk test | 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 | Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles | Baseline evaluation | 
| Sit-and-reach test | 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 | Testing leg strength and endurance in older adults | Baseline evaluation | 
| Chair sit-to-stand test | 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) | Stroke-specific, performance-based impairment index | Baseline evaluation | 
| Fugl-Meyer assessment (0-226, the higher the better) | 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) | Evaluate unilateral manual performance in hemiparetic patients after stroke | Baseline evaluation | 
| Manual function test (0-32, the higher the better) | 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) | 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) | 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 | Percentage of fat, bone, and muscle in the body | Baseline evaluation | 
| Body composition analysis | 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) | 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) | 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) | 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) | 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) | Assessment of depression in the elderly | Baseline evaluation | 
| Getriatic depression scale (0-15, the higher the more depressive) | Assessment of depression in the elderly | 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 | 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 | Follow-up evaluation (through study completion, an average of 6 weeks) |