Community-based Complex Exercise for Stroke Patients

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients

Conditions
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Stroke, Exercise

Intervention / Treatment
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* Behavioral: Stoke complex exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: rct
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise group<br> | Behavioral: Stoke complex exercise program<br>* 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<br>|
| No Intervention: Daily life group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6WMT | 6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians | Baseline and Follow-up evaluation (through study completion, an average of 6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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 | Baseline and Follow-up evaluation (through study completion, an average of 6 weeks) | 
| Body composition | Percentage of fat, bone, and muscle in the body | 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 | 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 | 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 | 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 | 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. | 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 | Baseline and Follow-up evaluation (through study completion, an average of 6 weeks) |