About this trial
A review of the literature suggests that high-intensity intermittent inspiratory muscle training (IMT) combined with the Otago exercise program may provide positive effects on early post-discharge recovery of patients aged 65 years and older undergoing coronary artery bypass graft (CABG) surgery. No studies have yet examined the effects of high-intensity intermittent IMT combined with the Otago exercise program on patients undergoing CABG surgery. This study is the first to evaluate the effects of high-intensity intermittent IMT combined with the Otago exercise program on pulmonary function, functional capacity, muscle strength, functional mobility, balance, anxiety and depression levels, frailty, and quality of life in elderly patients undergoing CABG surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65 years and older undergoing coronary artery bypass graft surgery
Hospital discharge realized (post operative ≥ 2 weeks)
No contraindications for exercise training
Not concurrently participating in another exercise training program
Disqualifiers
Cardiovascular instability (aortic dissection, unstable angina pectoris, acute decompensated heart failure, acute pericarditis or myocarditis, severe cardiac arrhythmia, ventricular aneurysm)
Uncontrolled hypertension and diabetes mellitus
Diagnosed with chronic lung disease
Cognitive impairment that prevents them from communicating with the physiotherapist
Trial design
Parallel
Treatments tested in this trial
High-intensity intermittent IMT and Otago Exercises Group
Other interventionPatients in the experimental group will perform 7 sets of high-intensity intermittent inspiratory muscle training (IMT) for eight weeks, one day a week face-to-face with the researcher and two days at home, for a total of three days, each set consisting of 2 minutes of loading and 1 minute of rest for a total of 21 minutes. The Otago exercise program will be conducted for eight weeks, two days a week home-based and one day face-to-face with the researcher. The Otago exercise program will be complemented with walking exercise every day of the week. The Otago exercise program is designed to be progressive. The protocol was created to increase the difficulty of training at four different levels and every 2 weeks. The Otago exercise program will be applied to both the experimental group and the control group in the same protocol.
Sham IMT and Otago Exercises Group
Other interventionPatients in the control group will perform 7 sets of sham inspiratory muscle training (IMT), consisting of 2 minutes of loading and 1 minute of rest in each set for a total of 21 minutes, one day a week face-to-face with the researcher and two days at home, for eight weeks. The Otago exercise program will be conducted for eight weeks, two days a week home-based and one day face-to-face with the researcher. The Otago exercise program will be complemented with walking exercise every day of the week. The Otago exercise program is designed to be progressive. The protocol was created to increase the difficulty of training at four different levels and every 2 weeks. The Otago exercise program will be applied to both the experimental group and the control group in the same protocol.
Treatment groups
Trial outcomes
Primary outcomes
Maximum inspiratory pressure
In the maximum inspiratory pressure measurement, patients will be asked to perform maximum inspiration for at least 2 seconds through the mouthpiece after first performing maximum expiration by sitting and using a nose clip. The measurement result will be recorded in units of cmH2O and percentage % of the expected value. The measurement will be considered satisfactory when a change of less than 10% is observed between the three measurements and the highest value is adopted.
Secondary outcomes
Maximum expiratory pressure
Patients will be asked to perform maximum expiration against a closed system for at least 2 seconds after maximum inspiration. The measurement result will be recorded in units of cmH2O and percentage % of the expected value. The measurement will be considered satisfactory when a change of less than 10% is observed between the three measurements and the highest value is adopted.
Forced vital capacity (FVC) massessment
Patients will perform a rapid and complete inhalation maneuver from functional residual capacity to total lung capacity, followed by a continuous and maximal exhalation maneuver lasting at least six seconds. Verbal and non-verbal encouragement will be provided throughout the maneuvers. The test will be terminated once acceptable repeatability is achieved. The results will be recorded in litres.
Assessment of functional capacity
Functional capacity will be assessed using the 6-Minute Walk Test. Patients will be instructed to walk at their own pace to cover the maximum possible distance along a 30-meter corridor within 6 minutes. The total distance walked will be recorded in meters. Heart rate, measured in beats per minute, blood pressure, measured in millimeters of mercury, and oxygen saturation, measured as a percentage, will be recorded both before and after the test. Patients will be informed that they may rest or slow down as needed during the test.
Evaluation of muscle strength
Isometric muscle strength of the M. Quadriceps femoris will be measured using a portable handheld dynamometer. Patients will be seated with the knee in full extension, and maximum resistance will be applied at the ankle to assess muscle strength. The measurement will be repeated three consecutive times, and the average value will be recorded in kilograms.
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