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

Primary Purpose

Robotic Surgical Procedures, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Standard respiratory physiotherapy
Standard respiratory physiotherapy and inspiratory muscle training
Sponsored by
Acibadem University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Robotic Surgical Procedures focused on measuring Robotic Heart Surgery, Inspiratory Muscle Training, Pulmonary Function Test, 6-Minute Walk Test, Respiratory Muscle Strength, Functional Capacity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Acıbadem MAA University Maslak Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Training Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline Forced Vital Capacity (FVC) at 4 weeks
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
Change from baseline Peak Expiratory Flow (PEF) at 4 weeks
Change from baseline maximum inspiratory pressure (MIP) at 4 weeks
Change from baseline maximum expiratory pressure (MEP) at 4 weeks
Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks
Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 6, 2018
Last Updated
April 25, 2022
Sponsor
Acibadem University
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1. Study Identification

Unique Protocol Identification Number
NCT03636633
Brief 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
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
February 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Acibadem University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Robotic Surgical Procedures, Heart Diseases
Keywords
Robotic Heart Surgery, Inspiratory Muscle Training, Pulmonary Function Test, 6-Minute Walk Test, Respiratory Muscle Strength, Functional Capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Training Group
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Standard respiratory physiotherapy
Intervention Description
Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.
Intervention Type
Other
Intervention Name(s)
Standard respiratory physiotherapy and inspiratory muscle training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Forced Vital Capacity (FVC) at 4 weeks
Time Frame
Four weeks
Title
Change from baseline Forced Expiratory Volume in 1 second (FEV1) at 4 weeks
Time Frame
Four weeks
Title
Change from baseline Peak Expiratory Flow (PEF) at 4 weeks
Time Frame
Four weeks
Title
Change from baseline maximum inspiratory pressure (MIP) at 4 weeks
Time Frame
Four weeks
Title
Change from baseline maximum expiratory pressure (MEP) at 4 weeks
Time Frame
Four weeks
Title
Change from baseline distance covered in six-minute walk test (6MWT) at 4 weeks
Time Frame
Four weeks
Title
Change from baseline carbon monoxide diffusion capacity of the lungs (DLCO) at 4 weeks
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Fatigue Severity Scale
Description
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.
Time Frame
Four weeks
Title
Fatigue Impact Scale
Description
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.
Time Frame
Four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Acıbadem MAA University Maslak Hospital
City
İstanbul
ZIP/Postal Code
34457
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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