Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIstanbul University - Cerrahpasa

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • High-intensity intermittent IMT and Otago Exercises Group

    Other intervention

    Patients 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 intervention

    Patients 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

28 Participants
are divided into 2 treatment groups
Group A: High-intensity intermittent IMT and Otago Exercises GroupExperimental treatment 1 intervention
Group B: Sham IMT and Otago Exercises GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.

Secondary outcomes

1

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.

Time frame
The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.
2

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.

Time frame
The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.
3

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.

Time frame
The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.
4

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.

Time frame
The baseline assessment will be conducted at 2 weeks post-surgery. Following the completion of the 8-week intervention protocol, the final assessment will be performed at 10 weeks post-surgery.

Other outcomes

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