Community-based Complex Exercise for Stroke Patients

NCT ID: NCT06012396

Last Updated: 2023-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Stroke; Exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise group

Group Type: EXPERIMENTAL

Stoke complex exercise program

Intervention Type: BEHAVIORAL

1. warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle

2. 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

Daily life group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stoke complex exercise program

1. warm-up(5min) flexibility exercise - neck, triceps brachii, biceps brachii, forearm, back, quadriceps, biceps femoris, ankle

2. 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sung-Hwa Ko

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

JUNGLIM LEE

Role: CONTACT

lim6668@naver.com

82+ 1049147899 ext. 82+ 0553604152

Facility Contacts

Sung-Hwa Ko, PhD

Role: primary

ijsh6679@gmail.com

+82-10-9344-4117

Other Identifiers

PNUYH_ETRI_3

Identifier Type: -

Identifier Source: org_study_id