- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05188352
Exercise Training in Patients After Bypass Surgery
Effects of Supervised Aerobic Exercise Training on Respiratory Parameters, Exercise Capacity, and Anxiety in Patients With Coronary Artery Bypass Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male gender,
- CABG surgery performed in the last one month,
- Patients with negative exercise test (on the 30 days after discharge).
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training group
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.
|
The program included diaphragmatic breathing exercises, thoracic expansion exercises, incentive spirometer exercises, and coughing techniques.
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. |
|
Active Comparator: Control 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 program included diaphragmatic breathing exercises, thoracic expansion exercises, incentive spirometer exercises, and coughing techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
[ Time Frame: Eight weeks ]
|
|
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.
|
[ Time Frame: Eight weeks ]
|
|
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. |
[ Time Frame: Eight weeks ]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline distance covered in six-minute walk test at 8 weeks.
Time Frame: [ Time Frame: Eight 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.
|
[ Time Frame: Eight weeks ]
|
|
Change from baseline Forced Vital Capacity (FVC) at 8 weeks
Time Frame: [ Time Frame: Eight 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.
|
[ 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 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.
|
[ 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 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. |
[ Time Frame: Eight weeks ]
|
|
Change from baseline anxiety level at 8 weeks.
Time Frame: [ Time Frame: Eight weeks ]
|
Anxiety level was evaluated by STAI-I and II.
|
[ Time Frame: Eight weeks ]
|
|
Change from baseline maximal oxygen consumption(VO2max) level at 8 weeks
Time Frame: [ Time Frame: Eight 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.
|
[ Time Frame: Eight weeks ]
|
|
Change from baseline maximal respiratory minute volume (VE), level at 8 weeks
Time Frame: [ Time Frame: Eight 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
|
[ Time Frame: Eight weeks ]
|
|
Change from baseline VO2max/kg level at 8 weeks
Time Frame: [ Time Frame: Eight 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
|
[ Time Frame: Eight weeks ]
|
|
Change from baseline maximal oxygen pulse (O2pulse) level at 8 weeks
Time Frame: [ Time Frame: Eight weeks ]
|
O2 pulse value was calculated from VO2 value which was divided to (by) heart rate at that minute.
|
[ Time Frame: Eight weeks ]
|
|
Change from baseline maximal MET level at 8 weeks
Time Frame: [ Time Frame: Eight 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
|
[ Time Frame: Eight weeks ]
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Semiramis Özyılmaz, Assoc. Prof., Bezmialem Vakif University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BVUsozyilmaz09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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