Exercise Training in Patients After Bypass Surgery

December 27, 2021 updated by: Bezmialem Vakif University

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.

Study Overview

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Semiramis Özyılmaz, Assoc. Prof., Bezmialem Vakif University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 27, 2021

First Submitted That Met QC Criteria

December 27, 2021

First Posted (Actual)

January 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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