Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft

NCT ID: NCT06013605

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-26
• Study Completion Date: 2023-07-07

Brief Summary

The goal of this clinical trial is to assess the effect of walking exercise on functional capacity and productivity in patients after Coronary Artery Bypass Graft who have completed phase II cardiac rehabilitation. The main question it aims to answer are:

1. What is the effect of walking exercise on functional capacity and productivity in patients after Coronary Artery Bypass Graft? Participants performed the exercise on the day agreed upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes. Researchers compared between intervention and control group to see if the effect between respondents who did walking and leg straightening exercises and also respondents who only did leg straightening.

Detailed Description

The research process was guided by The Consort Statement for RCT research. The process was conducted through the stages of enrollment, allocation, follow-up, and analysis. The recruitment process begins with an eligibility assessment process for potential respondents. This process was carried out when the patient conducted a phase 2 cardiac rehabilitation evaluation. Researchers initially checked patient data through medical records by looking at color codes (pink indicates Coronary Artery Bypass Graft patients), age, and location of residence. The patient's communication skills were observed during the evaluation process. The doctor determines the patient's risk stratification after the evaluation, then the researcher sees the patient's risk stratification from the assessment results in the medical record. The inclusion criteria in this study were patients aged 18-60 years, working, having mild to moderate risk stratification, living in the Jakarta, Bogor, Depok, Tangerang and Bekasi areas, and patients who could communicate well. Respondents who had been collected were then randomized using an envelope so that the respondents were divided into 2 groups where 21 respondents entered the intervention group and 21 respondents entered the control group.

Conditions

Coronary Artery Bypass; Cardiac Rehabilitation

Study Design

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

Study Groups

Intervention Group

Participants did walking exercise and usual care (leg straightening)

Group Type: EXPERIMENTAL

Walking Exercise and Leg Straightening

Intervention Type: BEHAVIORAL

Participants performed the exercise on the day agreed upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.

Control Group

Participants did usual care (leg straightening)

Group Type: EXPERIMENTAL

Leg Straightening

Intervention Type: BEHAVIORAL

Respondents did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.

Interventions

Walking Exercise and Leg Straightening

Participants performed the exercise on the day agreed upon with the researcher. Respondents did walking exercises 3 times per week for 4 weeks with a duration of 10 minutes of warm-up, 30 minutes of walking exercises, and 10 minutes of cooling down. Respondents also did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.

Intervention Type: BEHAVIORAL

Leg Straightening

Respondents did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Post- CABG patients in phase III of cardiac rehabilitation;
• Patients living in the JaBoDeTaBek area;
• Patients aged 18 - 60 years;
• Patients who have mild to moderate risk stratification;
• Patients who do not have limitations in mobilization such as using mobility aids (wheelchairs, walkers, crutches);
• Patients who do not perform routine aerobic exercise based on time intervals and types of exercise (such as cardiac exercise, cycling, ergocycle, etc.);
• Patients can communicate well and are willing to become respondents by signing informed consent.

Exclusion Criteria

• Patients with conditions that contraindicate exercise or rehabilitation such as unstable angina pectoris, resting systolic blood pressure >200 mmHg or diastolic >110 mmHg, clinical aortic valve stenosis, acute systemic disease, uncontrolled atrial or ventricular dysrhythmias, uncontrolled sinus tachycardia, uncompensated heart failure, third-degree atrioventricular block without pacing, active pericarditis or myocarditis, pulmonary thromboembolism, depression or ST-segment elevation at rest, Diabetic Mellitus with uncontrolled blood sugar, thyroiditis, hypokalemia, hyperkalemia, hypovolemia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Indra Gilang Pamungkas

Ns. Indra Gilang Pamungkas, S.Kep., M.Kep

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Indra G Pamungkas

Role: STUDY_CHAIR

Indonesia University

Locations

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

DP.04.03/KEP064/EC043/2023

Identifier Type: -

Identifier Source: org_study_id