Investigation of the Effects of Respiratory Muscle Training Combined With Otago Exercises in Elderly Patients Undergoing Coronary Artery Bypass Graft Surgery
1 other identifier
interventional
28
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedJune 24, 2025
June 1, 2025
11 months
May 23, 2025
June 15, 2025
Conditions
Keywords
Outcome Measures
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.
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
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
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
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
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
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.
- +8 more secondary outcomes
Study Arms (2)
High-intensity intermittent IMT and Otago Exercises Group
EXPERIMENTALPatients 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 COMPARATORPatients 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Istanbul University-Cerrahpaşa
Istanbul, 34320, Turkey (Türkiye)
Istanbul University-Cerrahpaşa
Istanbul, 34320, Turkey (Türkiye)
Istanbul University-Cerrahpaşa
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rengin Demir, Professor
Istanbul University-Cerrahpaşa, Cardiology Institute, Department of Cardiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MSc, PhD(c), Physiotherapist
Study Record Dates
First Submitted
May 23, 2025
First Posted
June 24, 2025
Study Start
July 1, 2025
Primary Completion
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- IPD and supporting information will be available beginning in June 2025 and will remain accessible through June 2030.
- Access Criteria
- Access to de-identified individual participant data (IPD) and supporting information will be available to qualified researchers upon request. Researchers interested in accessing the data may contact via email at celebisaemre@gmail.com. There will be no requirement to submit a formal research proposal, data sharing agreement, or obtain prior approval. The data provided will include all measurement data collected in the study, de-identified to protect participant privacy. Requests will be handled on a first-come, first-served basis and no independent review or committee approval is necessary. The data may be used for secondary analyses, validation studies, or meta-analyses.
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.