Clinical trial NCT06013605: Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft
Official title: Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass
Cardiac Rehabilitation
Keywords: Coronary Artery Bypass
Walking
Functional Capacity
Productivity
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Functional Capacity
timeFrame: 6 minutes
measure: Productivity
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Indra G Pamungkas
role: STUDY_CHAIR
References: