Heart Diseases Clinical Trial
Official title:
The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery
Verified date | April 2022 |
Source | Acibadem University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
During the past decade, especially with the advancement of technology, major innovations and developments have been observed in the field of surgery. Cardiac surgery is one of the important area of the surgery who renews itself day by day and adds innovations to the nature in terms of patients' comfort. One of the greatest developments in cardiac surgery in this sense is the tendency to reduce the size of the incisions with less interventional procedures. Robotic surgery is getting more and more meaningful in this area. Despite the downsizing of the surgical incisions, postoperative pulmonary complications have not completely disappeared in the robotic cardiac surgery. Major respiratory problems following traditional cardiac surgery are gas exchange problems, atelectasis, decreased coughing force and sputum retention. The effectiveness of respiratory physiotherapy applied after traditional cardiac surgery for the resolution of these complications has been proved by various investigations. Inspiratory muscle training (IMT) has been found to improve autonomic modulation in heart failure patients as well as to increase inspiratory muscle strength in applied patient populations, reduce blood pressure in hypertensive patients, and increase functional capacity in elderly individuals. Considering these benefits, when inspiratory muscle training is given to people with traditional cardiac surgery, respiratory muscle strengths, respiratory functions and functional capacities are increased compared to those not given to these patients. However, although there are complications after robotic cardiac surgery, there are no studies in the literature about respiratory physiotherapy or inspiratory muscle training. Thus, the subject of this study is the comparison of the effects of standard respiratory physiotherapy and standard respiratory physiotherapy plus inspiratory muscle training on the respiratory functions, respiratory muscle strength and functional capacity of the patients with the robotic heart surgery.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 21, 2021 |
Est. primary completion date | March 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Being suitable for robotic cardiac surgery, - Being hospitalized to have a robotic heart surgery, - No complications during surgery, - To be extubated in intensive care unite after surgery , - Stable clinical condition, - To be transferred from ICU to the hospital room on the first day after surgery. Exclusion Criteria: - Chronic obstructive pulmonary disease, - Unstable angina, - Acute decompensated heart failure, - Acute pericarditis and myocarditis, - Complex arrhythmia, - Uncontrolled hypertension, - Serious orthopedic and neurological impairment, - Uncontrolled diabetes, - Body Mass Index > 30. |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem MAA University Maslak Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Acibadem University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline Forced Vital Capacity (FVC) at 4 weeks | Four weeks | ||
Primary | Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks | Four weeks | ||
Primary | Change from baseline Peak Expiratory Flow (PEF) at 4 weeks | Four weeks | ||
Primary | Change from baseline maximum inspiratory pressure (MIP) at 4 weeks | Four weeks | ||
Primary | Change from baseline maximum expiratory pressure (MEP) at 4 weeks | Four weeks | ||
Primary | Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks | Four weeks | ||
Primary | Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks | Four weeks | ||
Secondary | Fatigue Severity Scale | The 9 item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. Assessment type: Patient reported outcomes.The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree.The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. | Four weeks | |
Secondary | Fatigue Impact Scale | The fatigue impact scale was developed to assess the symptom of fatigue as part of an underlying chronic disease or condition. Consisting of 40 items, the instrument evaluates the effect of fatigue on three domains of daily life: cognitive functioning, physical functioning, and psychosocial functioning. Respondents are asked to rate the extent to which fatigue has interfered with certain aspects of their day-to-day functioning using a scale that ranges from 0 ("no problem") to 4 ("extreme problem"). Scores are then tallied to produce an overall score with a potential maximum of 160. Subscale scores can also be calculated to give a more nuanced impression of fatigue. | Four weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04624412 -
Different Intensities of Continuous Aerobic Exercises in Cardiac Rehab Phase 2
|
N/A | |
Completed |
NCT05563701 -
Evaluation of the LVivo Image Quality Scoring (IQS)
|
||
Recruiting |
NCT04561908 -
Transcatheter Microguidewire Drilling for Transseptal Left Atrial Access
|
N/A | |
Active, not recruiting |
NCT06190743 -
Perception of Cardiovascular Risk
|
||
Completed |
NCT04562636 -
Evaluating a Messaging Campaign in the United States
|
N/A | |
Completed |
NCT04580095 -
Artificial Intelligence for Improved Echocardiography
|
N/A | |
Recruiting |
NCT03277365 -
MyGeneRank: A Digital Platform for Next-Generation Genetic Studies
|
N/A | |
Active, not recruiting |
NCT05553106 -
Evaluation of Cognitive Status, Kinesiophobia, Physical Activity Level, and Functional Performance in Coronary Intensive Care
|
||
Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Enrolling by invitation |
NCT03314818 -
Natural History of Carotid Plaque as Determined by 3D Ultrasound
|
N/A | |
Withdrawn |
NCT03289104 -
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
|
N/A | |
Completed |
NCT02917213 -
Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
|
||
Completed |
NCT02046902 -
Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
|
||
Completed |
NCT01909349 -
Web-based Aftercare Intervention for Cardiac Patients
|
N/A | |
Completed |
NCT01944254 -
The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients
|
N/A | |
Recruiting |
NCT01457586 -
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
|
Phase 4 | |
Recruiting |
NCT01541163 -
Heart and Ischemic STrOke Relationship studY
|
N/A | |
Recruiting |
NCT01207167 -
Mediators of Atherosclerosis in South Asians Living in America
|
||
Terminated |
NCT00968383 -
Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
|
N/A |