Clinical trial NCT03636633: The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic Surgical Procedures
Heart Diseases
Keywords: Robotic Heart Surgery
Inspiratory Muscle Training
Pulmonary Function Test
6-Minute Walk Test
Respiratory Muscle Strength
Functional Capacity
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Forced Vital Capacity (FVC) at 4 weeks
timeFrame: Four weeks
measure: Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
timeFrame: Four weeks
measure: Change from baseline Peak Expiratory Flow (PEF) at 4 weeks
timeFrame: Four weeks
measure: Change from baseline maximum inspiratory pressure (MIP) at 4 weeks
timeFrame: Four weeks
measure: Change from baseline maximum expiratory pressure (MEP) at 4 weeks
timeFrame: Four weeks
measure: Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks
timeFrame: Four weeks
measure: Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks
timeFrame: Four weeks
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: Four weeks
measure: Fatigue Impact Scale
timeFrame: Four weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acıbadem MAA University Maslak Hospital
Study officials:
References: