Comparison of the Effects of Different Physiotherapy and Rehabilitation Methods on Open Heart Surgery

October 12, 2020 updated by: Yasemin Şahbaz, University of Beykent

Comparison of the Effects of Different Physiotherapy and Rehabilitation Methods in Phase I Following Open Heart Surgery

The aim of this study is to compare the effects of different physiotherapy and rehabilitation methods in hospitalization after Open Heart Surgery (OHS). In this context, it is planned that patients undergoing OHS surgery will be randomly divided into 3 groups.

  1. Group routine cardiac rehabilitation program (RCRP)
  2. Group RCRP and inspiratory muscle training
  3. Group RCRP and virtual reality application Treatment of patients will be administered twice daily during their stay in the hospital. The patients will be evaluated by clinical measurements and scales based on patient notification and before and after the treatment and their effectiveness and superiority over each other will be determined.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Purpose of our study Comparison of the effects of different physiotherapy and rehabilitation methods in hospitalization after Open Heart Surgery (OHS).

Expected results: Routine cardiac rehabilitation program (RCRP) + virtual reality group and RCRP + inspiratory muscle training group pain, dyspnea, anxiety, depression, quality of life, respiratory muscle strength We believe that there will be good progress in pulmonary function, 6 minutes walking distance evaluation results, and best developments will occur in RCRP + virtual reality + inspiratory muscle training group.

In this context, it is planned that patients undergoing OHS surgery will be randomly divided into 3 groups. Group 1 routine cardiac rehabilitation program (RCRP) 2. Group RCRP and inspiratory muscle training 3. Group RCRP and virtual reality application Treatment of patients will be administered twice daily during their stay in the hospital. The patients will be evaluated by clinical measurements and scales based on patient notification and before and after the treatment and their effectiveness and superiority over each other will be determined.

Literature summary:

Open Heart Surgery is one of the most effective and reliable treatment options in coronary artery diseases and the most common coronary artery bypass surgery in the world is used to prolong the life expectancy of patients and reduce symptoms. Patients undergoing cardiac rehabilitation program after Open Heart Surgery are extremely important and the benefits of cardiac rehabilitation; reduction in symptoms, exercise tolerance and increase in workforce, improvement in blood lipid and general risk profile, decrease in smoking, stress management and self-improvement, atherosclerotic status, new coronary attacks, hospitalizations, decreases in morbidity and mortality.Despite the well-known positive effects of open heart surgery, respiratory complications are common in patients with decreased respiratory muscle strength in the postoperative period.

Inspiratory muscle training with yararlı Threshold iştir performed after open heart surgery helps to increase respiratory muscle strength and endurance, and potential beneficial effects have been demonstrated in cardiac patients undergoing coronary artery bypass surgery.

In a randomized controlled trial of 38 patients undergoing coronary artery bypass surgery, respiratory muscle training has been shown to provide improvements in maximum inspiratory pressure, maximum expiratory pressure, peak flow rate, and tidal volume results. In another randomized controlled trial of 47 patients with coronary artery bypass surgery, the patients' postoperative ventilation capacity and respiratory muscle strength decreased. It was reported that inspiratory muscle training increased the tidal volume and vital capacity parameters.

Hospitalization is an experience that increases the anxiety and anxiety of the individual. Individual in the hospital environment; they may feel threatened, feel fear and insecurity. Using virtual reality glasses can help patients to feel different in a different environment. This may be beneficial to the patient in eliminating the negative emotions brought by the hospital environment and may positively affect their participation in the treatment.

Virtual reality applications, which have gained importance in many areas of medicine, have shown that improved exercise programs and enriched environment provide better functional performance in patients undergoing cardiac surgery. After reviewing the literature related to virtual reality combined rehabilitation applications after coronary artery bypass surgery, there are only three studies in the form of walking and exercise training in virtual environment.

In a randomized controlled trial of 60 patients undergoing coronary artery bypass surgery, the patients were divided into two groups: the traditional cardiac rehabilitation group and the additional virtual reality group of traditional cardiac rehabilitation. The patients were evaluated on the day of preoperative, postoperative first, third and discharge days with Functional Independence Measurement (FIM), 6 Minute Walk Test and Nottigham Health Profile. Traditional cardiac rehabilitation program applied to both groups twice a day was determined as breathing exercises, airway cleaning techniques, metabolic and motor exercise training. In the study group, motor exercises in traditional cardiac rehabilitation program were performed twice a day using virtual reality and kinesiotherapy. As a result of evaluations, cardiac rehabilitation combined with virtual reality application has been shown to provide better functional performance in patients.

In 2006, 20 patients who had undergone coronary artery bypass surgery were included. It has been shown that a rehabilitation program with virtual reality applications is useful to improve the physical capacity of patients. In another study conducted on 32 patients undergoing coronary artery bypass surgery in 2005, it was reported that the inclusion of a virtual reality environment in cardiac rehabilitation programs would accelerate the maximum recovery of patients' cardiovascular functions.

In the literature, there is no study in which the inspiratory muscle training was performed in a virtual environment created by virtual reality glasses.

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Beykent University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 25-70 age range
  • Undergoing open heart surgery
  • Hemodynamically stable
  • Ambulatory
  • No advanced vision defect
  • The physician authorized by the operating physician for participation in the exercise
  • Patients who agreed to participate in the study.

Exclusion Criteria:

  • The presence of pulmonary, neurological, musculoskeletal disease limiting participation in exercise training
  • Patients at high risk (ejection fraction below 40 percent)
  • Dissectant aneurysm
  • Patients who cannot be cooperative in verbal and / or auditory terms
  • Psychological and / or perceptual cooperative patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Routine cardiac rehabilitation program (RCRP)atient education
Other: Group A: Group routine cardiac rehabilitation program (RCRP)

Patient education, Chest Physiotherapy, Abdominal and chest breathing, Bronchial hygiene techniques, Segmental breathing exercises, Triflow, exercise and mobilization,graduated exercise, positioning, active joint movement, moving inside bed, sitting at the edge of the bed, transfer from bed to chair, standing walking program, up and down stairs.

Evaluations for each patient (preoperative and just before discharge) Spirometric measurements Intraoral pressure measurementDyspnea assessment (BORG), Pain assessment (VAS), Evaluation of anxiety and depression (HAD) Evaluation of functional capacity (6 minutes walking test) Quality of Life (MacNew Heart Disease Specific Quality of Life Questionnaire)
Experimental: Group B
routine cardiac rehabilitation program + virtual reality
Other: Group B: Group RCRP and inspiratory muscle training

use of additional virtual reality goggles in the routine cardiac rehabilitation program Virtual reality glasses installed in the patient will feel the best way to feel an environment.

Virtual reality glasses are planned to be used 15 minutes by increasing the usage period.

Evaluations for each patient (preoperative and just before discharge) Spirometric measurements Intraoral pressure measurementDyspnea assessment (BORG), Pain assessment (VAS), Evaluation of anxiety and depression (HAD) Evaluation of functional capacity (6 minutes walking test) Quality of Life (MacNew Heart Disease Specific Quality of Life Questionnaire)
Experimental: Group C
RCRP + inspiratory muscle training
Other: Group C: Group RCRP and virtual reality application

nspiratory muscle training with "Threshold" for routine cardiac rehabilitation Training intensity

- 30% of the maximum measured inspiratory pressure per week (15 min.). Every 10 breaths after rest.

Evaluations for each patient (preoperative and just before discharge) Spirometric measurements Intraoral pressure measurementDyspnea assessment (BORG), Pain assessment (VAS), Evaluation of anxiety and depression (HAD) Evaluation of functional capacity (6 minutes walking test) Quality of Life (MacNew Heart Disease Specific Quality of Life Questionnaire)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of respiratory functions with simple spirometric measurements
Time Frame: the preoperative and 10th day
spirometric measurement with spirometry
the preoperative and 10th day
intraoral pressure measurement (Maximum inspiratory pressure maximum expiratory pressure)
Time Frame: the preoperative and 10th day
Maximum inspiratory pressure maximum expiratory pressure
the preoperative and 10th day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea assessment
Time Frame: the preoperative and 10th day

With modified borg dyspnea scale:

Modified Borg Scale is a scale that is frequently used to evaluate the intensity of dyspnea and the severity of rest dyspnea. It consists of ten items that define the severity of dyspnea according to their degree. The high score is directly proportional to the severity of dyspnea.
the preoperative and 10th day
Peak expiratory flow
Time Frame: the preoperative and 10th day
peak flow meter
the preoperative and 10th day
Evaluation of functional capacity with 6 minutes walking test
Time Frame: the preoperative and 10th day

With 6 minutes walking test:

The 6-minute walk test is one of the functional exercise capacity assessment tests. In this test, participants are asked to walk as long as possible within 6 minutes in a 30 meter (m) corridor. When they feel fatigue or pain, they are advised to stop and rest when they feel ready to walk. At the end of 6 minutes, the total distance of the patients walking is recorded. Heart rates, systolic and diastolic blood pressures, O2 saturation, perceived fatigue and dyspnea levels are recorded before and after the test.
the preoperative and 10th day
Evaluation of anxiety and depression
Time Frame: the preoperative and 10th day

With hospital anxiety and depression scale(HAD):

The HADS includes anxiety and depression subscales. The scale is a self-report scale and consists of 14 items, 7 of which are depression (even numbers) and 7 are anxiety symptoms (odd numbers).
the preoperative and 10th day
Pain assessment
Time Frame: the preoperative and 10th day

With Visuel Analog Scale:

Participants are asked to mark the point where they feel their pain on a 10 centimeter (cm) horizontal line. 0-no pain, 10-unbearable pain. Night, activity and pain conditions are evaluated separately at rest.
the preoperative and 10th day
Quality of Life assessment
Time Frame: the preoperative and 10th day

MacNew Heart Disease Specific Quality of Life Questionnaire:

The Mac New Heart Disease Quality of Life Questionnaire is designed to assess how patients' physical, emotional, social functions and daily activities are affected over a 2-week period. The scale consists of three sub-dimensions and 27 items, some of which are into more than one sub-dimension. The subscale scores are calculated by taking the environments of the responses to the questions in each sub-dimension, and when the possible scores vary between 1-7, the higher scores indicate a better quality of life. The Turkish validity and reliability study of the scale was performed in 2008 by Daskapan et al. made by.
the preoperative and 10th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Beykent

Collaborators

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Yasemin Şahbaz, Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Anticipated)

October 30, 2020

Study Completion (Anticipated)

November 30, 2020

Study Registration Dates

First Submitted

March 22, 2019

First Submitted That Met QC Criteria

May 15, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 12, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UBeykent

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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