Coronary Artery BypassNCT06013605
Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft
A study testing Walking Exercise and Leg Straightening and Leg Straightening in people with Coronary Artery Bypass and Cardiac Rehabilitation, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Bypass, Cardiac Rehabilitation
- What is being tested?
- Walking Exercise and Leg Straightening and Leg Straightening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 26 May 2023to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, 11420
About this study
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:
- 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.
Read the 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
- Being tested
- Walking Exercise and Leg Straightening, Leg Straightening
- Keywords
- Coronary Artery Bypass, Walking, Functional Capacity, Productivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking Exercise and Leg StraighteningBehavioural
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 StraighteningBehavioural
Respondents did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants did walking exercise and usual care (leg straightening) Receives: Behavioral: Walking Exercise and Leg Straightening |
| Control Group | Experimental | Participants did usual care (leg straightening) Receives: Behavioral: Leg Straightening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 minutes
Productivity
The ability of post-CABG patients to perform work and physical activities was assessed using the WPAI.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start26 May 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery BypassStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Gilang Pamungkas, Universitas Indonesia
- Investigators
- Indra G Pamungkas, Study chair, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013605
- Sponsor's protocol ID
- DP.04.03/KEP064/EC043/2023
- Status last verified
- Aug 2023
- First submitted
- 22 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft
- ClinicalTrials.gov ID
- NCT06013605
- Acronym / sponsor ID
- DP.04.03/KEP064/EC043/2023
- Conditions
- Coronary Artery Bypass, Cardiac Rehabilitation
- Keywords
- Coronary Artery Bypass, Walking, Functional Capacity, Productivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a parallel Randomized Controlled Trial (RCT) with a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Walking Exercise and Leg StraighteningParticipants did walking exercise and usual care (leg straightening) |
| Control Group | Experimental | Behavioral: Leg StraighteningParticipants did usual care (leg straightening) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking Exercise and Leg StraighteningParticipants 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. | Behavioural | Intervention Group |
| Leg StraighteningRespondents did leg straightening every day for 4 weeks with a frequency of 1 time a day for 10 minutes. | Behavioural | Control Group |
Primary outcome
Functional Capacity
Time frame: 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.
Productivity
Time frame: 5 minutes
The ability of post-CABG patients to perform work and physical activities was assessed using the WPAI.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Bypass
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Active, not recruiting
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
Coronary Artery Bypass Graft (CABG)
Recruiting
Postural Mobilization Compared to Noradrenaline Only in Off-Pump CABG Surgery
Coronary Artery Disease With Need for Bypass Surgery, Coronary Artery Disease(CAD)
Active, not recruitingPhase 1
Comparison of Analgesic Efficacy Between Ultrasound Guided Serratus Anterior Plane Block or Thoracic Paravertebral Block Versus Intravenous Fentanyl for On-pump Coronary Artery Bypass Graft Surgery
Intra and Post Operative Pain Management, Fast Track Program,(Enhanced Recovery After Surgery (ERAS))
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indra G Pamungkas study chair
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Exercise and Leg Straightening and Leg Straightening in people with Coronary Artery Bypass and Cardiac Rehabilitation, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Capacity (time frame: 6 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.