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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT06013605
Collaborator
(none)
42
1
2
1.4
30.4

Study Details

Study Description

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.
Condition or Disease Intervention/Treatment Phase
  • Behavioral: Walking Exercise and Leg Straightening
  • Behavioral: Leg Straightening
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
Primary Purpose:
Treatment
Official Title:
Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft
Actual Study Start Date :
May 26, 2023
Actual Primary Completion Date :
Jul 7, 2023
Actual Study Completion Date :
Jul 7, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Participants did walking exercise and usual care (leg straightening)

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.

Experimental: Control Group

Participants did usual care (leg straightening)

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

Outcome Measures

Primary Outcome Measures

  1. Functional Capacity [6 minutes]

    The ability of post-CABG patients to be able to perform expected activities or workloads can be done using the 6 Minutes Walking Test.

  2. Productivity [5 minutes]

    The ability of post-CABG patients to perform work and physical activities was assessed using the WPAI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cardiovascular Center Harapan Kita Jakarta DKI Jakarta Indonesia 11420

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Study Chair: Indra G Pamungkas, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Indra Gilang Pamungkas, Ns. Indra Gilang Pamungkas, S.Kep., M.Kep, Indonesia University
ClinicalTrials.gov Identifier:
NCT06013605
Other Study ID Numbers:
  • DP.04.03/KEP064/EC043/2023
First Posted:
Aug 28, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Indra Gilang Pamungkas, Ns. Indra Gilang Pamungkas, S.Kep., M.Kep, Indonesia University

Study Results

No Results Posted as of Aug 28, 2023