Complex Exercise Program for Stroke Patients

Stroke Clinical Trial

— CEPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616858
• Other study ID #: PNUYH_ETRI_2
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Program, Communication
• Sports Physical Therapy
• Stroke

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)