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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636633
• Other study ID #: ATADEK-2018-2/55
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: February 21, 2021

Study information

• Verified date: April 2022
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Heart Diseases
• Respiratory Aspiration
• Robotic Surgical Procedures

Intervention

Other:
• Standard respiratory physiotherapy
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.
• Standard respiratory physiotherapy and inspiratory muscle training
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure.

Locations

Country	Name	City	State
Turkey	Acibadem MAA University Maslak Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

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