Coronary Artery Bypass Graft (CABG)NCT07034846
Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
A study testing High-intensity intermittent IMT and Otago Exercises Group in people with Coronary Artery Bypass Graft (CABG), run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft (CABG)
- What is being tested?
- High-intensity intermittent IMT and Otago Exercises Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 13 May 2025to 25 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Istanbul University-Cerrahpaşa
Istanbul, 34320
Istanbul University-Cerrahpaşa
Istanbul
About this study
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.
Read the detailed description
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
- Coronary Artery Bypass Graft (CABG)
- Being tested
- High-intensity intermittent IMT and Otago Exercises Group, Sham IMT and Otago Exercises Group
- Keywords
- Exercise, Inspiratory muscle training, Otago Exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity intermittent IMT and Otago Exercises GroupOther
Also called High-intensity intermittent IMT 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.
Sham IMT and Otago Exercises GroupOther
Also called Sham IMT 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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity intermittent IMT and Otago Exercises Group | Experimental | 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. Receives: Other: High-intensity intermittent IMT and Otago Exercises Group |
| Sham IMT and Otago Exercises Group | Active comparator | 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. Receives: Other: Sham IMT and Otago Exercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (13)
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: 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.
Assessment of functional mobility
Mobility will be assessed using the Timed Up and Go Test. Patients will be instructed to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. The total time taken to complete this task will be recorded in seconds. A time of 13.5 seconds or longer is indicative of a higher risk of falls.
Measured: 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.
Balance assessment
Balance performance will be assessed using the Berg Balance Scale, which consists of 14 items scored from 0 to 4, with a maximum total score of 56. Scores between 0-20 indicate balance impairment, 21-40 indicate acceptable balance, and 41-56 indicate good balance performance. Additionally, balance confidence will be evaluated using the Activity Specific Balance Confidence Scale, which includes 16 questions assessing confidence in performing daily activities indoors and outdoors. Each item is scored from 0% (unsafe) to 100% (completely safe), and the average score is calculated to provide an overall balance confidence percentage. Higher scores represent greater confidence.
Measured: 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.
Assessment of anxiety and depression level
Anxiety and depression levels will be assessed using the Hospital Anxiety and Depression Scale. This scale evaluates the risk and severity of anxiety and depression symptoms through 14 questions-seven assessing anxiety (odd-numbered) and seven assessing depression (even-numbered). Responses are rated on a four-point Likert scale ranging from 0 to 3. The total score ranges from 0 to 42. Higher scores indicate more severe symptoms.
Measured: 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.
Frailty assessment
Frailty will be assessed using the Fried Frailty Phenotype based on five criteria: Participants with three or more criteria will be classified as frail.
Measured: 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.
Assessment of quality of life
Patients' quality of life will be assessed using the Short Form-36 questionnaire, which comprises 36 items covering eight subscales related to physical and mental health. Each subscale is scored between 0 and 100, with higher scores indicating a better overall quality of life.
Measured: 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.
Forced expiratory volume in one second (FEV1) assessment
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.
Measured: 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.
FEV1/FVC ratio
FVC and FEV1 results will be compared and expressed as percentages.
Measured: 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.
Forced expiratory flow 25-75% (FEF25-75) assessment
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 expressed in litres per second.
Measured: 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.
Peak expiratory flow (PEF) assessment
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 expressed in litres per minute.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start13 May 2025
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft (CABG)Studies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadık Emre ÇELEBİ, Istanbul University - Cerrahpasa
- Investigators
- Rengin Demir, Professor, Study director, Istanbul University-Cerrahpaşa, Cardiology Institute, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034846
- Sponsor's protocol ID
- 2025/186
- Status last verified
- Nov 2026
- First submitted
- 23 May 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, including all measurement data collected in the study, will be shared with researchers upon request. The data will become available after the completion of the study and publication of the results, and will remain accessible for 5 years thereafter. Researchers may request access via email at celebisaemre@gmail.com. No formal approval process will be required to obtain the data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07034846
- Acronym / sponsor ID
- 2025/186
- Conditions
- Coronary Artery Bypass Graft (CABG)
- Keywords
- Exercise, Inspiratory muscle training, Otago Exercises
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity intermittent IMT and Otago Exercises Group | Experimental | Other: High-intensity intermittent IMT and Otago Exercises GroupPatients 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. |
| Sham IMT and Otago Exercises Group | Active comparator | Other: Sham IMT and Otago Exercises GroupPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity intermittent IMT and Otago Exercises GroupAlso: High-intensity intermittent IMT groupPatients 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. | Other | High-intensity intermittent IMT and Otago Exercises Group |
| Sham IMT and Otago Exercises GroupAlso: Sham IMT groupPatients 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. | Other | Sham IMT and Otago Exercises Group |
Primary outcome
Maximum inspiratory pressure
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.
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.
13 secondary outcomes
Maximum expiratory pressure
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.
Forced vital capacity (FVC) massessment
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.
Assessment of functional capacity
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.
Evaluation of muscle strength
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.
Assessment of functional mobility
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.
Balance assessment
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.
Assessment of anxiety and depression level
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.
Frailty assessment
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.
Assessment of quality of life
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.
Forced expiratory volume in one second (FEV1) assessment
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.
FEV1/FVC ratio
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.
Forced expiratory flow 25-75% (FEF25-75) assessment
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.
Peak expiratory flow (PEF) assessment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, including all measurement data collected in the study, will be shared with researchers upon request. The data will become available after the completion of the study and publication of the results, and will remain accessible for 5 years thereafter. Researchers may request access via email at celebisaemre@gmail.com. No formal approval process will be required to obtain the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rengin Demir, Professor study director
Istanbul University-Cerrahpaşa, Cardiology Institute, Department of Cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity intermittent IMT and Otago Exercises Group in people with Coronary Artery Bypass Graft (CABG), run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.