Community-based Complex Exercise for Stroke Patients (COB-CEPS)

Safety and Validation of Community Rehabilitation Exercise Program for Stroke Patients

A lot of physical and social effects of exercise programs and daily physical education have already been proven for stroke patients after discharge. However, stroke patients have shown a passive attitude in participating in physical education or exercise programs for life, and the local community lacked appropriate guidelines or experience in guiding exercise and physical education for stroke patients, so they had a burden on instructing exercise. In this study, an appropriate complex exercise program was established for patients after discharge through analysis of domestic and foreign research data to provide an environment and opportunity to exercise in the community, and based on the results, stroke patients actively exercise in the community in the future. The goal is to provide a basis for doing so.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Exercise
• Intervention / Treatment: Behavioral: Stoke complex exercise program

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JUNGLIM LEE; Phone Number: 82+ 0553604152 82+ 1049147899; Email: lim6668@naver.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: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Stroke patients aged 30 years or older residing in the community
• Those who can walk independently and have a score of 3 or higher in the Functional Ambulation Category (FAC)
• The daily life dependence of the stroke patient is a person who can perform simple tasks necessary for daily life, Those who scored 2 points or less on the Modified Rankin Scale (mRS)
• Subjects with no or mild stiffness of the affected upper and lower limbs, with a score of 1 or less on the Modified Ashworth Scale (MAS)
• All 3 major joints of the affected upper and lower limbs (Manual Muscle Test (MMT)) are 3 points (F grade) or higher ruler

Exclusion Criteria:

• With moderate or severe cognitive dysfunction, Korean-Mini Mental state test (Korean-Mini Mental state test) Those who scored less than 18 points in the Examination (K-MMSE)
• A person with a moderate or higher fall risk and less than 41 points on the Berg Balance Scale (BBS)
• Those who have difficulty understanding the intervention exercise program or expressing symptoms due to severe language impairment
• Those who cannot apply this intervention exercise program due to serious cardiovascular disease
• Those who have musculoskeletal disorders that make it impossible to exercise
• Those who are judged unsuitable for this study under the judgment of a specialist in rehabilitation medicine due to other diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise group	Behavioral: Stoke complex exercise program; warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle; main exercise(40min) aerobic exercise(20min)- use stepper, treadmill, high intensity HRR60%, RPE 11~14 low intensity HRR30%, RPE 9~11 repeated interval training strength and balance exercises(20min)- program1. upper(shoulder press, chest press, biceps curl), lower(hip flexion, knee extension), Core(plank exercise, sit up) program2. upper(seated back row, triceps extension), lower(hip extension, hip abduction, knee flexion, Core(superman exercise, bridge exercise) repeated ever other day program1, program2 clean-up(5min) - same as warm-up
No Intervention: Daily life group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6WMT	6-minute walk test practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRS	modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability The scale runs from 0-6, running from perfect health without symptoms to death.	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
BBS	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 and Follow-up evaluation (through study completion, an average of 6 weeks)
FAC	Functional ambulation category (0-5, the higher the better) 6-point functional walking test that evaluates ambulation ability	visit 1, visit 23
MMT	Manual Muscle Testing (MMT) is a technique used in physical therapy and rehabilitation to assess the strength and function of individual muscles or muscle groups. It involves the application of specific resistance against the muscle's movement to determine its ability to generate force. This technique includes assessing major muscles from the upper and lower limbs opposing the therapist's force and grading the patient's muscle strength on a 0 to 5 scale	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
TUG	Timed up and go To determine fall risk and measure the progress of balance	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Grip Strength	Grip strength measure of muscular strength or the maximum force/tension generated by one's forearm muscles	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Body composition	Percentage of fat, bone, and muscle in the body	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
Physical activity	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 and Follow-up evaluation (through study completion, an average of 6 weeks)
EQ-5D	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 and Follow-up evaluation (through study completion, an average of 6 weeks)
GDS	Getriatic depression scale (0-15, the higher the more depressive) Assessment of depression in the elderly	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
sit to stand	Recording the number of times sitting and rising for 30 seconds by measuring the strength of the lower extremities of the elderly	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
flexibility test	Measure the length beyond the tip of the toes with the hand stretched out in a seated forward bending position.	Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)
coordination test	Assessment of Coordination Measures in Older Adults. Draw a rectangle with a width of 3.6m and a length of 1.6m, place a chair at a point 2.4m from the center in both corners, and measure the time to return to the left and right rear corners twice in 0.1 second units	Baseline and 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 6, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 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_3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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