Complex Exercise Program for Stroke Patients
CEPS
Safety and Cardiopulmonary Efficacy of Complex Exercise Program for Stroke Patients in the Community
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2022
CompletedFirst Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 15, 2023
February 1, 2023
1.8 years
October 31, 2022
August 13, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (32)
Functional ambulation category (0-5, the higher the better)
Baseline evaluation
Functional ambulation category (0-5, the higher the better)
Follow-up evaluation (through study completion, an average of 6 weeks)
Berg balance scale (0-56, the higher the better)
Baseline evaluation
Berg balance scale (0-56, the higher the better)
Follow-up evaluation (through study completion, an average of 6 weeks)
Timed up and go
Baseline evaluation
- +27 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALGroup with exercise program
Control group
NO INTERVENTIONGroup without exercise program
Interventions
Stretching exercise, aerobic exercise, strengthening and balancing exercise
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 15, 2022
Study Start
March 18, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
August 15, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share