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Complex Exercise Program for Stroke Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05616858
Acronym
CEPS
Enrollment
100
Registered
2022-11-15
Start date
2022-03-18
Completion date
2023-12-31
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Program, Communication, Sports Physical Therapy, Stroke

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.

Interventions

BEHAVIORALComplex exercise program

Stretching exercise, aerobic exercise, strengthening and balancing exercise

Sponsors

Pusan National University Yangsan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Randomized, open-label, case-control study

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peak VO2Baseline evaluationMaximal VO2 from cardiopulmonary exercise test

Secondary

MeasureTime frameDescription
Functional ambulation category (0-5, the higher the better)Baseline evaluation6-point functional walking test that evaluates ambulation ability
Berg balance scale (0-56, the higher the better)Baseline evaluationObjectively determine a patient's ability to safely balance during a series of predetermined tasks
Timed up and goBaseline evaluationTo determine fall risk and measure the progress of balance
Grip strengthBaseline evaluationmeasure of muscular strength or the maximum force/tension generated by one's forearm muscles
6-minute walk testBaseline evaluationpractical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians
Figure-of-eight walk testBaseline evaluationMeasurement tool that assesses the ability to walk on a curved path
Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better)Baseline evaluationScreening of dementia and to investigate the possible changes of optimal cutoff scores
Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better)Baseline evaluationA brief and simple instrument measuring health related quality of life
Chair sit-to-stand testBaseline evaluationTesting leg strength and endurance in older adults
Fugl-Meyer assessment (0-226, the higher the better)Baseline evaluationStroke-specific, performance-based impairment index
Manual function test (0-32, the higher the better)Baseline evaluationEvaluate unilateral manual performance in hemiparetic patients after stroke
Modified Barthel Index (Korean version) (0-100, the higher the better)Baseline evaluationMeasure of physical disability used widely to assess behaviour relating to activities of daily living
Body composition analysisBaseline evaluationPercentage of fat, bone, and muscle in the body
Getriatic depression scale (0-15, the higher the more depressive)Baseline evaluationAssessment of depression in the elderly
International Physical Activity Questionnaire (No scores)Baseline evaluation27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old
Sit-and-reach testBaseline evaluationMeasure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles

Countries

South Korea

Contacts

Primary ContactSung-Hwa Ko, PhD
ijsh6679@gmail.com+82-10-9344-4117
Backup ContactSungchul Huh
dr.huhsc@gmail.com+82-1093542177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026