Clinical trial NCT05616858: Complex Exercise Program for Stroke Patients
Official title: Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Sports Physical Therapy
Program, Communication
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label, case-control study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. Therefore, the study provides patients with an adequate guide to a complex exercise program after discharge based on the medical records.


Eligibility criteria: 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

Primary outcomes:
measure: Peak VO2
timeFrame: Baseline evaluation
measure: Peak VO2
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary outcomes:
measure: Functional ambulation category (0-5, the higher the better)
timeFrame: Baseline evaluation
measure: Functional ambulation category (0-5, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Berg balance scale (0-56, the higher the better)
timeFrame: Baseline evaluation
measure: Berg balance scale (0-56, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Timed up and go
timeFrame: Baseline evaluation
measure: Timed up and go
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Grip strength
timeFrame: Baseline evaluation
measure: Grip strength
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: 6-minute walk test
timeFrame: Baseline evaluation
measure: 6-minute walk test
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Figure-of-eight walk test
timeFrame: Baseline evaluation
measure: Figure-of-eight walk test
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Sit-and-reach test
timeFrame: Baseline evaluation
measure: Sit-and-reach test
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Chair sit-to-stand test
timeFrame: Baseline evaluation
measure: Chair sit-to-stand test
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Fugl-Meyer assessment (0-226, the higher the better)
timeFrame: Baseline evaluation
measure: Fugl-Meyer assessment (0-226, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Manual function test (0-32, the higher the better)
timeFrame: Baseline evaluation
measure: Manual function test (0-32, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Modified Barthel Index (Korean version) (0-100, the higher the better)
timeFrame: Baseline evaluation
measure: Modified Barthel Index (Korean version) (0-100, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Body composition analysis
timeFrame: Baseline evaluation
measure: Body composition analysis
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)
timeFrame: Baseline evaluation
measure: Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
timeFrame: Baseline evaluation
measure: Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: Getriatic depression scale (0-15, the higher the more depressive)
timeFrame: Baseline evaluation
measure: Getriatic depression scale (0-15, the higher the more depressive)
timeFrame: Follow-up evaluation (through study completion, an average of 6 weeks)
measure: International Physical Activity Questionnaire (No scores)
timeFrame: Baseline evaluation
measure: International Physical Activity Questionnaire (No scores)
timeFrame: 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: