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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-07-01

Brief Summary

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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.

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Detailed Description

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Coronary artery bypass graft (CABG) surgery aims to revascularize the myocardium by bypassing one or more coronary arteries narrowed or occluded due to atherosclerosis. Procedures such as sternotomy, cardiopulmonary bypass, general anesthesia, and pleural drain placement can lead to postoperative complications including hypersecretion, hypoxemia, decreased pulmonary compliance, reduced exercise capacity, and impaired lung function. These complications may cause prolonged immobilization and additional pulmonary issues. Moreover, protein catabolism after cardiovascular surgery leads to muscle protein loss, which is exacerbated by immobilization, slowing protein synthesis and accelerating muscle fiber breakdown and cell death, thereby contributing to muscle loss progression. Postural balance also decreases following CABG, potentially leading to reduced functional activities, increased fall risk, morbidity, and mortality. CABG negatively impacts patients' quality of life and causes functional limitations. Anxiety about disease recurrence and fear of death after discharge contribute to psychological stress for patients and relatives, further impairing recovery.

Frailty is closely associated with cardiopulmonary diseases and is common after CABG surgery. A study evaluating 180 bypass patients with an average age of approximately 69 years found that 23.3% were frail. High frailty scores post-CABG correlate with adverse outcomes such as prolonged hospital stays and rehospitalization within 30 days.

Inspiratory muscle training (IMT) is a method designed to strengthen inspiratory muscles by providing airway resistance during breathing. Effective IMT requires appropriate intensity, duration, and frequency. Training at or above 30% of maximal inspiratory pressure (MIP) for 20-30 minutes daily, five days a week, over 5-12 weeks produces structural changes in respiratory muscles.

Previous studies demonstrated that IMT improves inspiratory muscle strength, functional capacity, psychosocial status, and quality of life in patients undergoing CABG surgery. Additionally, moderate to high-intensity IMT combined with aerobic and strengthening exercises during cardiac rehabilitation increases exercise capacity, inspiratory muscle strength, and quality of life more than sham IMT combined with similar exercises.

High-intensity intermittent IMT has recently shown beneficial results in cardiovascular and pulmonary diseases. In heart failure patients, high-intensity intermittent IMT performed in cycles of loading and rest improved dyspnea, frailty, fatigue, inspiratory muscle strength, respiratory muscle endurance, exercise capacity, and quality of life, compared to sham IMT. Similar positive effects were observed in patients with bronchiectasis and elderly individuals undergoing home-based IMT, with improvements in inspiratory muscle function, balance, and physical performance.

IMT has demonstrated effectiveness in reducing dyspnea, improving respiratory muscle strength, pulmonary function, functional capacity, daily living activities, and quality of life in patients with chronic obstructive pulmonary disease, chronic kidney disease, chronic heart failure, and in healthy populations. It also enhances postural stability due to the diaphragm's mechanical role in lumbar stabilization.

The Otago exercise program, developed in New Zealand to prevent falls, is a home-based training protocol including warm-up, strengthening, balance, and walking exercises. Performed three times weekly with progressively increasing intensity, it improves lower extremity muscle strength, balance, and mobility in elderly individuals.

Few studies have investigated the combination of IMT and the Otago exercise program. Recent research in healthy adults and diabetic patients indicates that combined training improves balance, inspiratory muscle function, mobility, respiratory function, muscle strength, and endurance more than either intervention alone.

This prospective, randomized, controlled, single-blind study will evaluate the effects of the Otago exercise program combined with high-intensity IMT on elderly patients undergoing CABG surgery. The study will be conducted at Istanbul University-Cerrahpaşa Cardiology Institute, Department of Cardiovascular Surgery.

Conditions

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Coronary Artery Bypass Graft (CABG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High-intensity intermittent IMT and Otago Exercises Group

Patients aged 65 years and over who have undergone CABG surgery and who are at least 2 weeks postoperatively and who meet the inclusion criteria will be identified. Then, patients who volunteer to participate in the study will be referred.

Group Type EXPERIMENTAL

High-intensity intermittent IMT and Otago Exercises Group

Intervention Type OTHER

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

Patients aged 65 years and over who have undergone CABG surgery and who are at least 2 weeks postoperatively and who meet the inclusion criteria will be identified. Then, patients who volunteer to participate in the study will be referred.

Group Type ACTIVE_COMPARATOR

Sham IMT and Otago Exercises Group

Intervention Type OTHER

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.

Interventions

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High-intensity intermittent IMT and Otago Exercises Group

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.

Intervention Type OTHER

Sham IMT and Otago Exercises Group

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.

Intervention Type OTHER

Other Intervention Names

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High-intensity intermittent IMT group Sham IMT group

Eligibility Criteria

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Inclusion Criteria

* 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
* Have the means to enter a home-based rehabilitation program
* Patients who agree to participate voluntarily will be included in the study program.

Exclusion Criteria

* 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
* Failure to maintain the exercise training program
* Patients with severe orthopedic or neurological disorders will not be included.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No