NCT06013605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

1 month

First QC Date

August 22, 2023

Last Update Submit

August 22, 2023

Conditions

Keywords

Coronary Artery BypassWalkingFunctional CapacityProductivity

Outcome Measures

Primary Outcomes (2)

  • 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

  • Productivity

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

    5 minutes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants did walking exercise and usual care (leg straightening)

Behavioral: Walking Exercise and Leg Straightening

Control Group

EXPERIMENTAL

Participants did usual care (leg straightening)

Behavioral: Leg Straightening

Interventions

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 Group

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

Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Study Officials

  • Indra G Pamungkas

    Indonesia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors were not involved during the intervention process. Respondents were also asked not to inform the outcome assessor of the measures they received.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ns. Indra Gilang Pamungkas, S.Kep., M.Kep

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

May 26, 2023

Primary Completion

July 7, 2023

Study Completion

July 7, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations