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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05616858
Other study ID # PNUYH_ETRI_2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 18, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Pusan National University Yangsan Hospital
Contact Sung-Hwa Ko, PhD
Phone +82-10-9344-4117
Email ijsh6679@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Complex exercise program
Stretching exercise, aerobic exercise, strengthening and balancing exercise

Locations

Country Name City State
Korea, Republic of Pusan National University Yangsan Hospital Yangsan Gyeongnam

Sponsors (1)

Lead Sponsor Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peak VO2 Maximal VO2 from cardiopulmonary exercise test Baseline evaluation
Primary Peak VO2 Maximal VO2 from cardiopulmonary exercise test Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability Baseline evaluation
Secondary Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Berg balance scale (0-56, the higher the better) Objectively determine a patient's ability to safely balance during a series of predetermined tasks Baseline evaluation
Secondary Berg balance scale (0-56, the higher the better) Objectively determine a patient's ability to safely balance during a series of predetermined tasks Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Timed up and go To determine fall risk and measure the progress of balance Baseline evaluation
Secondary Timed up and go To determine fall risk and measure the progress of balance Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles Baseline evaluation
Secondary Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary 6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians Baseline evaluation
Secondary 6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Figure-of-eight walk test Measurement tool that assesses the ability to walk on a curved path Baseline evaluation
Secondary Figure-of-eight walk test Measurement tool that assesses the ability to walk on a curved path Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Sit-and-reach test Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles Baseline evaluation
Secondary Sit-and-reach test Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Chair sit-to-stand test Testing leg strength and endurance in older adults Baseline evaluation
Secondary Chair sit-to-stand test Testing leg strength and endurance in older adults Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Fugl-Meyer assessment (0-226, the higher the better) Stroke-specific, performance-based impairment index Baseline evaluation
Secondary Fugl-Meyer assessment (0-226, the higher the better) Stroke-specific, performance-based impairment index Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Manual function test (0-32, the higher the better) Evaluate unilateral manual performance in hemiparetic patients after stroke Baseline evaluation
Secondary Manual function test (0-32, the higher the better) Evaluate unilateral manual performance in hemiparetic patients after stroke Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Modified Barthel Index (Korean version) (0-100, the higher the better) Measure of physical disability used widely to assess behaviour relating to activities of daily living Baseline evaluation
Secondary Modified Barthel Index (Korean version) (0-100, the higher the better) Measure of physical disability used widely to assess behaviour relating to activities of daily living Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Body composition analysis Percentage of fat, bone, and muscle in the body Baseline evaluation
Secondary Body composition analysis Percentage of fat, bone, and muscle in the body Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better) Screening of dementia and to investigate the possible changes of optimal cutoff scores Baseline evaluation
Secondary Korean Mini-Mental Status Examination (K-MMSE) (0-30, the higher the better) Screening of dementia and to investigate the possible changes of optimal cutoff scores Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better) A brief and simple instrument measuring health related quality of life Baseline evaluation
Secondary Euro-Quality of Life-5 Dimension (EQ-5D) (5-25, the higher the better) A brief and simple instrument measuring health related quality of life Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly Baseline evaluation
Secondary Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly Follow-up evaluation (through study completion, an average of 6 weeks)
Secondary International Physical Activity Questionnaire (No scores) 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old Baseline evaluation
Secondary International Physical Activity Questionnaire (No scores) 27-item self-reported measure of physical activity for use with individual adult patients aged 15 to 69 years old Follow-up evaluation (through study completion, an average of 6 weeks)
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