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

Pusan National University Yangsan Hospital1 site in 1 country100 target enrollmentMarch 18, 2022

ConditionsStroke Sports Physical Therapy Program, Communication

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Pusan National University Yangsan Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: Peak VO2
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 18, 2022

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Pusan National University Yangsan Hospital

Responsible Party

Principal Investigator

Sung-Hwa Ko

Associate professor

Pusan National University Yangsan Hospital

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

Outcomes

Primary Outcomes

Peak VO2

Time Frame: Follow-up evaluation (through study completion, an average of 6 weeks)

Maximal VO2 from cardiopulmonary exercise test

Secondary Outcomes

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