Community-based Complex Exercise for Stroke Patients

NCT06012396 | Unknown DMC

• 1 other identifier: PNUYH_ETRI_3
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• MRS

  Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

• BBS

  Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

• FAC

  visit 1, visit 23

• MMT

  Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

• TUG

  Baseline and Follow-up evaluation (through study completion, an average of 6 weeks)

Study Arms (2)

Exercise group

EXPERIMENTAL

Behavioral: Stoke complex exercise program

Daily life group

NO INTERVENTION

Interventions

Stoke complex exercise program 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

Exercise group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

JUNGLIM LEE

CONTACT

82+ 1049147899; lim6668@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: rct

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: August 25, 2023
• Study Start: March 6, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

KR (1)