Clinical trial NCT05188352: Exercise Training in Patients After Bypass Surgery
Official title: Effects of Supervised Aerobic Exercise Training on Respiratory Parameters, Exercise Capacity, and Anxiety in Patients With Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change from baseline maximum inspiratory pressure at 8 weeks.
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline maximum expiratory pressure at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
measure: Maximal exercise capacity
timeFrame: [ Time Frame: Eight weeks ]
Secondary outcomes:
measure: Change from baseline distance covered in six-minute walk test at 8 weeks.
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline Forced Vital Capacity (FVC) at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 8 weeks .
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline Forced Expiratory flow from between 25% to 75% of Vital Capacity at 8 weeks.
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline anxiety level at 8 weeks.
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline maximal oxygen consumption(VO2max) level at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline maximal respiratory minute volume (VE), level at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline VO2max/kg level at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline maximal oxygen pulse (O2pulse) level at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
measure: Change from baseline maximal MET level at 8 weeks
timeFrame: [ Time Frame: Eight weeks ]
Other outcomes:
Locations:
Study officials:
affiliation: Bezmialem Vakif University
name: Semiramis Özyılmaz, Assoc. Prof.
role: STUDY_CHAIR
References: