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Clinical Trials/NCT03636633
NCT03636633CompletedNot Applicable

The Effect of Inspiratory Muscle Training and Respiratory Physiotherapy on Pulmonary Functions, Respiratory Muscle Strength and Functional Capacity in Patients With Robotic Heart Surgery

Acibadem University1 site in 1 country20 target enrollmentStarted: March 21, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Control Group

Active Comparator

Standard respiratory physiotherapy

Patients in this group will receive standard respiratory physiotherapy two times a day, 7 days a week for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves.

Intervention: Standard respiratory physiotherapy (Other)

Training Group

Experimental

Standard respiratory physiotherapy and inspiratory muscle train

In addition to the standard respiratory physiotherapy program, patients in this group will receive 3 sets of inspiratory muscle training with 10 repetitions twice a day for 4 weeks. During hospitalization, sessions will be performed by a respiratory physiotherapist. After discharge, other sessions will be performed at home by themselves.

Intervention: Standard respiratory physiotherapy and inspiratory muscle training (Other)

Outcomes

Primary Outcomes

Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks

Time Frame: Four weeks

Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks

Time Frame: Four weeks

Change from baseline Forced Vital Capacity (FVC) at 4 weeks

Time Frame: Four weeks

Change from baseline maximum inspiratory pressure (MIP) at 4 weeks

Time Frame: Four weeks

Change from baseline maximum expiratory pressure (MEP) at 4 weeks

Time Frame: Four weeks

Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks

Time Frame: Four weeks

Change from baseline Peak Expiratory Flow (PEF) at 4 weeks

Time Frame: Four weeks

Secondary Outcomes

  • Fatigue Severity Scale(Four weeks)
  • Fatigue Impact Scale(Four weeks)

Investigators

Sponsor
Acibadem University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Aslı İrem Dönmez

PT, Research Assistant at Faculty of Health Sciences, Acibadem University

Acibadem University

Study Sites (1)

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