Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06013605
Other study ID # DP.04.03/KEP064/EC043/2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2023
Est. completion date July 7, 2023

Study information

Verified date August 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date July 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia National Cardiovascular Center Harapan Kita Jakarta DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Functional Capacity The ability of post-CABG patients to be able to perform expected activities or workloads can be done using the 6 Minutes Walking Test. 6 minutes
Primary Productivity The ability of post-CABG patients to perform work and physical activities was assessed using the WPAI. 5 minutes
See also
  Status Clinical Trial Phase
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Active, not recruiting NCT05773287 - Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation N/A
Completed NCT05551429 - Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
Completed NCT02542163 - Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR) N/A
Not yet recruiting NCT05989594 - Home-based Mobile Guided Exercise-based Cardiac Rehabilitation Among Patients Undergoing TAVR N/A
Active, not recruiting NCT05026957 - A Digitally-Supported Shared Decision Making Approach for Coronary Artery Disease Patients During Cardiac Rehabilitation N/A
Recruiting NCT03734185 - Cardiac Rehabilitation: From Hospital to Municipal Setting. N/A
Recruiting NCT05826587 - Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention N/A
Completed NCT03174106 - Longterm Follow-up of Cardiac Patients With an Smartphone-Application N/A
Recruiting NCT05725655 - Hot Water Immersion After Myocardial Infarction N/A
Not yet recruiting NCT05019157 - Cardiac Telerehabilitation Effectiveness Using Wearable Sensors N/A
Recruiting NCT06025526 - Effectiveness of the Aktivplan Digital Intervention (ACTIVE-CaRe Pilot) N/A
Recruiting NCT05099692 - CHD Patient's Concern on Cardiac Rehabilitation
Completed NCT06306235 - Are Non-participants of Conventional Centre-based Cardiac Rehabilitation Willing to Participate in Cardiac Telerehabilitation?
Recruiting NCT06039969 - Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.
Not yet recruiting NCT06065319 - Wearables and Cardiac Rehabilitation
Recruiting NCT06127537 - Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL N/A
Completed NCT04738383 - Feasibility and Acceptance of Changes in Medical Supervision of Exercise Groups in Cardiac Rehabilitation N/A
Active, not recruiting NCT03922529 - Modified Application of Cardiac Rehabilitation for Older Adults N/A
Completed NCT00956657 - Improving Cardiac Rehabilitation Session Attendance: A Randomised Controlled Trial N/A