Clinical trial NCT06012396: Community-based Complex Exercise for Stroke Patients
Official title: Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Exercise
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 126
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: rct
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 6WMT
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary outcomes:
measure: MRS
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: BBS
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: FAC
timeFrame: visit 1, visit 23
measure: MMT
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: TUG
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Grip Strength
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Body composition
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Physical activity
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: EQ-5D
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: GDS
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: sit to stand
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: flexibility test
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
measure: coordination test
timeFrame: Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeongnam
Study officials:
References: