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

NCT03636633 | Completed

• 1 other identifier: ATADEK-2018-2/55
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

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

  Four weeks

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

  Four weeks

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

  Four weeks

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

  Four weeks

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

  Four weeks

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

  Four weeks

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

  Four weeks

Secondary Outcomes (2)

• Fatigue Severity Scale

  Four weeks

• Fatigue Impact Scale

  Four weeks

Study Arms (2)

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.

Other: Standard respiratory physiotherapy

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.

Other: Standard respiratory physiotherapy and inspiratory muscle training

Interventions

Standard respiratory physiotherapy OTHER

Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.

Control Group

Standard respiratory physiotherapy and inspiratory muscle training OTHER

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.

Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem MAA University Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, Research Assistant at Faculty of Health Sciences, Acibadem University

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 17, 2018
• Study Start: March 21, 2018
• Primary Completion: March 21, 2019
• Study Completion: February 21, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

TU (1)