Coronary Artery Bypass SurgeryNCT05188352
Exercise Training in Patients After Bypass Surgery
A study testing Chest physiotherapy and Aerobic exercise training in people with Coronary Artery Bypass Surgery, run by Bezmialem Vakif University.
Trial summary
Based on clinical experience both physical condition and psychological recovery after surgery are individually variable. Exercise training plays an important part, has been recommended for CABS patients in order to enhance recovery. Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Coronary Artery Bypass Surgery
- What is being tested?
- Chest physiotherapy and Aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2018
- 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 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender,
- CABG surgery performed in the last one month,
- Patients with negative exercise test (on the 30 days after discharge).
Who cannot join
- Valve surgery,
- Perioperative myocardial infarction assessed by electrocardiographic (ECG) and creatine kinase isoenzyme changes,
- Postoperative angina, diabetes mellitus, chronic renal failure, unstable angina, intermittent claudication, heart valve dysfunction (moderate or severe), severe cardiac arrhythmias, -Presence of symptoms at rest or with minimal exertion,
- Chronic obstructive pulmonary disease (>70% FEV1/FVC), and
- Any disorder that might influence exercise performance physically (e.g. severe back pain, history stroke).
About this study
Official title: Effects of Supervised Aerobic Exercise Training on Respiratory Parameters, Exercise Capacity, and Anxiety in Patients With Coronary Artery Bypass Surgery
Based on clinical experience both physical condition and psychological recovery after surgery are individually variable. Exercise training plays an important part, has been recommended for CABS patients in order to enhance recovery. Regular exercise following CABS has shown that, in addition to the expected improvements in exercise capacity as a result of the surgery itself, patients who participate in cardiac rehabilitation can expect to see additional gains in exercise capacity and risk factor profiles. Exercise training also increases personal self-esteem and self-confidence, can alleviate depression and fear, and increase the sense of well-being. The aim of this study was to examine the effects of supervised aerobic exercise training on pulmonary function, functional capacity, maximal exercise capacity, and anxiety in patients after coronary artery bypass surgery.
Read the detailed description
Patients in the training group received supervised aerobic exercise training on the treadmill with the intensity of 60-75% of maximal VO2 for 40-50 minutes, 3 days a week for 8 weeks in a cardiac rehabilitation unit. Work-load was gradually increased during eight-week period. Each session had a five-minute warm-up and cool-down period. Blood pressure and ECG were recorded during training sessions before exercise, at the third minute of each workload, after exercise, and during each minute of the recovery period. In addition, conventional chest physiotherapy and was instructed to continue their daily physical activity program at home patients in this group Patients in the control group received no aerobic exercise training but were asked to continue their chest physiotherapy and daily physical activity program at home.
The same researcher, who was blind to the group allocation, were evaluated all patients for pulmonary functions, respiratory muscle strength and submaximal functional capacity, exercise capacity, and anxiety level initially and after 8 weeks.
- Conditions
- Coronary Artery Bypass Surgery
- Being tested
- Chest physiotherapy, Aerobic exercise training
- Keywords
- coronary artery patients, coronary artery bypass surgery, respiratory muscle strength, oxygen consumption, aerobic exercise, pulmonary function test, maximal exercise test with oxygen consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest physiotherapyOther
The program included diaphragmatic breathing exercises, thoracic expansion exercises, incentive spirometer exercises, and coughing techniques.
Aerobic exercise trainingOther
A treadmill was used for aerobic exercise. Training intensity was used at 60-75% of maximal VO2.
Each session had a five-minute warm-up and cool-down period. Blood pressure and ECG were recorded during training sessions before exercise, at the third minute of each workload, after exercise, and during each minute of the recovery period.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | Patients in the training group received supervised aerobic exercise training on the treadmill with the intensity of 60-75% of maximal VO2 for 40-50 minutes, 3 days a week for 8 weeks. Work-load was gradually increased during the eight-week period. In addition, conventional chest physiotherapy and was instructed to continue their daily physical activity program at home patients in this group. Receives: Other: Chest physiotherapy; Other: Aerobic exercise training |
| Control group | Active comparator | Patients in the control group received no aerobic exercise training but were asked to continue their chest physiotherapy and daily physical activity program at home. Receives: Other: Chest physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline maximum inspiratory pressure at 8 weeks.
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength was measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.
Measured: [ Time Frame: Eight weeks ]
Change from baseline maximum expiratory pressure at 8 weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength was measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.
Measured: [ Time Frame: Eight weeks ]
Maximal exercise capacity
The incremantal, symptom-limited cardiopulmonary exercise test (CPET) was used to assess exercise capacity.
Symptom-limited maximal exercise test with oxygen consumption measurement (peak VO2) (Minjhard Oxycon-3) on the treadmill using a Modified Bruce protocol.
Measured: [ Time Frame: Eight weeks ]
Secondary outcomes (10)
Change from baseline distance covered in six-minute walk test at 8 weeks.
Change from baseline functional capacity test at 8 weeks. Functional capacity was assessed by the 6 minute walking test. The test was performed according to American Thoracic Society (ATS) criteria. Patients were allowed to rest for 10 minutes before the test. Heart rate, blood pressure, respiratory frequency, oxygen saturation, fatigue and dyspnea perception were recorded before and after the test. Walking distance was calculated.
Measured: [ Time Frame: Eight weeks ]
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC was evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: [ Time Frame: Eight weeks ]
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks .
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function at 8 weeks. FEV1 was evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: [ Time Frame: Eight weeks ]
Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity at 8 weeks.
Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity at 8 weeks.
FMF was evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: [ Time Frame: Eight weeks ]
Change from baseline anxiety level at 8 weeks.
Anxiety level was evaluated by STAI-I and II.
Measured: [ Time Frame: Eight weeks ]
Change from baseline maximal oxygen consumption(VO2max) level at 8 weeks
Respiratory parameters were continuously measured by using computerized 'Minjhard Oxycon-3'. Measurements were performed in each 30 second, before, during and after exercise test and during each recovery period for five minutes parameters measured.
Measured: [ Time Frame: Eight weeks ]
Change from baseline maximal respiratory minute volume (VE), level at 8 weeks
Respiratory parameters were continuously measured by using computerized 'Minjhard Oxycon-3'. Measurements were performed in each 30 second, before, during and after exercise test and during each recovery period for five minutes parameters measured
Measured: [ Time Frame: Eight weeks ]
Change from baseline VO2max/kg level at 8 weeks
Respiratory parameters were continuously measured by using computerized 'Minjhard Oxycon-3'. Measurements were performed in each 30 second, before, during and after exercise test and during each recovery period for five minutes parameters measured
Measured: [ Time Frame: Eight weeks ]
Change from baseline maximal oxygen pulse (O2pulse) level at 8 weeks
O2 pulse value was calculated from VO2 value which was divided to (by) heart rate at that minute.
Measured: [ Time Frame: Eight weeks ]
Change from baseline maximal MET level at 8 weeks
Respiratory parameters were continuously measured by using computerized 'Minjhard Oxycon-3'. Measurements were performed in each 30 second, before, during and after exercise test and during each recovery period for five minutes parameters measured
Measured: [ Time Frame: Eight weeks ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study startJan 2017
- Primary completionJun 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Semiramis Özyılmaz, Assoc. Prof., Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188352
- Sponsor's protocol ID
- BVUsozyilmaz09
- Status last verified
- Dec 2021
- First submitted
- 27 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Aerobic Exercise Training on Respiratory Parameters, Exercise Capacity, and Anxiety in Patients With Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT05188352
- Acronym / sponsor ID
- BVUsozyilmaz09
- Conditions
- Coronary Artery Bypass Surgery
- Keywords
- coronary artery patients, coronary artery bypass surgery, respiratory muscle strength, oxygen consumption, aerobic exercise, pulmonary function test, maximal exercise test with oxygen consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 12 Jan 2022 (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.
Based on clinical experience both physical condition and psychological recovery after surgery are individually variable. Exercise training plays an important part, has been recommended for CABS patients in order to enhance recovery. Regular exercise following CABS has shown that, in addition to the expected improvements in exercise capacity as a result of the surgery itself, patients who participate in cardiac rehabilitation can expect to see additional gains in exercise capacity and risk factor profiles. Exercise training also increases personal self-esteem and self-confidence, can alleviate depression and fear, and increase the sense of well-being. The aim of this study was to examine the effects of supervised aerobic exercise training on pulmonary function, functional capacity, maximal exercise capacity, and anxiety in patients after coronary artery bypass surgery.
Detailed description
Patients in the training group received supervised aerobic exercise training on the treadmill with the intensity of 60-75% of maximal VO2 for 40-50 minutes, 3 days a week for 8 weeks in a cardiac rehabilitation unit. Work-load was gradually increased during eight-week period. Each session had a five-minute warm-up and cool-down period. Blood pressure and ECG were recorded during training sessions before exercise, at the third minute of each workload, after exercise, and during each minute of the recovery period. In addition, conventional chest physiotherapy and was instructed to continue their daily physical activity program at home patients in this group Patients in the control group received no aerobic exercise training but were asked to continue their chest physiotherapy and daily physical activity program at home.
The same researcher, who was blind to the group allocation, were evaluated all patients for pulmonary functions, respiratory muscle strength and submaximal functional capacity, exercise capacity, and anxiety level initially and after 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Chest physiotherapy, Other: Aerobic exercise trainingPatients in the training group received supervised aerobic exercise training on the treadmill with the intensity of 60-75% of maximal VO2 for 40-50 minutes, 3 days a week for 8 weeks. Work-load was gradually increased during the eight-week period. In addition, conventional chest physiotherapy and was instructed to continue their daily physical activity program at home patients in this group. |
| Control group | Active comparator | Other: Chest physiotherapyPatients in the control group received no aerobic exercise training but were asked to continue their chest physiotherapy and daily physical activity program at home. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male gender,
- CABG surgery performed in the last one month,
- Patients with negative exercise test (on the 30 days after discharge).
Key exclusion criteria (5 listed)
- Valve surgery,
- Perioperative myocardial infarction assessed by electrocardiographic (ECG) and creatine kinase isoenzyme changes,
- Postoperative angina, diabetes mellitus, chronic renal failure, unstable angina, intermittent claudication, heart valve dysfunction (moderate or severe), severe cardiac arrhythmias, -Presence of symptoms at rest or with minimal exertion,
- Chronic obstructive pulmonary disease (>70% FEV1/FVC), and
- Any disorder that might influence exercise performance physically (e.g. severe back pain, history stroke).
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 |
|---|---|---|
| Chest physiotherapyThe program included diaphragmatic breathing exercises, thoracic expansion exercises, incentive spirometer exercises, and coughing techniques. | Other | Control group, Training group |
| Aerobic exercise trainingA treadmill was used for aerobic exercise. Training intensity was used at 60-75% of maximal VO2. Each session had a five-minute warm-up and cool-down period. Blood pressure and ECG were recorded during training sessions before exercise, at the third minute of each workload, after exercise, and during each minute of the recovery period. | Other | Training group |
Primary outcome
Change from baseline maximum inspiratory pressure at 8 weeks.
Time frame: [ Time Frame: Eight weeks ]
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength was measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.
Change from baseline maximum expiratory pressure at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength was measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.
Maximal exercise capacity
Time frame: [ Time Frame: Eight weeks ]
The incremantal, symptom-limited cardiopulmonary exercise test (CPET) was used to assess exercise capacity. Symptom-limited maximal exercise test with oxygen consumption measurement (peak VO2) (Minjhard Oxycon-3) on the treadmill using a Modified Bruce protocol.
10 secondary outcomes
Change from baseline distance covered in six-minute walk test at 8 weeks.
Time frame: [ Time Frame: Eight weeks ]
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks .
Time frame: [ Time Frame: Eight weeks ]
Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity at 8 weeks.
Time frame: [ Time Frame: Eight weeks ]
Change from baseline anxiety level at 8 weeks.
Time frame: [ Time Frame: Eight weeks ]
Change from baseline maximal oxygen consumption(VO2max) level at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
Change from baseline maximal respiratory minute volume (VE), level at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
Change from baseline VO2max/kg level at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
Change from baseline maximal oxygen pulse (O2pulse) level at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
Change from baseline maximal MET level at 8 weeks
Time frame: [ Time Frame: Eight weeks ]
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 12 Jan 2022.
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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.
Semiramis Özyılmaz, Assoc. Prof. study chair
Bezmialem Vakif University
Questions about this trial
What is this clinical trial studying?
A study testing Chest physiotherapy and Aerobic exercise training in people with Coronary Artery Bypass Surgery, run by Bezmialem Vakif University.
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 3 inclusion and 5 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline maximum inspiratory pressure at 8 weeks. (time frame: [ Time Frame: Eight weeks ]). The study lists 3 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 12 Jan 2022.