Complex Exercise Program for Stroke Patients (CEPS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Sports Physical Therapy; Program, Communication
• Intervention / Treatment: Behavioral: Complex exercise program

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sung-Hwa Ko, PhD; Phone Number: +82-10-9344-4117; Email: ijsh6679@gmail.com
• Study Contact Backup: Name: Sungchul Huh; Phone Number: +82-1093542177; Email: dr.huhsc@gmail.com

Study Locations

• Korea, Republic of
  • Gyeongnam
    • Yangsan, Gyeongnam, Korea, Republic of, 50612
      • Recruiting
      • Pusan National University Yangsan Hospital
      • Contact: Sung-Hwa Ko, PhD; Phone Number: +82-10-9344-4117; Email: ijsh6679@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Group with exercise program	Behavioral: Complex exercise program; Stretching exercise, aerobic exercise, strengthening and balancing exercise
No Intervention: Control group; Group without exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go	To determine fall risk and measure the progress of balance	Baseline evaluation
Grip strength	measure of muscular strength or the maximum force/tension generated by one's forearm muscles	Baseline evaluation
6-minute walk test	practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians	Baseline evaluation
Figure-of-eight walk test	Measurement tool that assesses the ability to walk on a curved path	Baseline evaluation
Sit-and-reach test	Measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles	Baseline evaluation
Chair sit-to-stand test	Testing leg strength and endurance in older adults	Baseline evaluation
Body composition analysis	Percentage of fat, bone, and muscle in the body	Baseline evaluation
Functional ambulation category (0-5, the higher the better)	6-point functional walking test that evaluates ambulation ability	Baseline evaluation
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)
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
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)
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)
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)
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)
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)
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)
Chair sit-to-stand test	Testing leg strength and endurance in older adults	Follow-up evaluation (through study completion, an average of 6 weeks)
Fugl-Meyer assessment (0-226, the higher the better)	Stroke-specific, performance-based impairment index	Baseline evaluation
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)
Manual function test (0-32, the higher the better)	Evaluate unilateral manual performance in hemiparetic patients after stroke	Baseline evaluation
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)
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
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)
Body composition analysis	Percentage of fat, bone, and muscle in the body	Follow-up evaluation (through study completion, an average of 6 weeks)
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
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)
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
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)
Getriatic depression scale (0-15, the higher the more depressive)	Assessment of depression in the elderly	Baseline evaluation
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)
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
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)

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: PNUYH_ETRI_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No