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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03955536
Enrollment
36
Registered
2019-05-20
Start date
2019-02-01
Completion date
2020-11-30
Last updated
2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Heart Surgery

Keywords

Cardiac Rehabilitation, Virtual Reality, Respiratory Muscle Training, Open Heart Surgery

Brief summary

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.

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.

Interventions

OTHERGroup 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)

OTHERGroup 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)

OTHERGroup 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)

Sponsors

Istanbul University - Cerrahpasa
CollaboratorOTHER
University of Beykent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking 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

Intervention model description

randomized controlled trial 3 groups 1. Group routine cardiac rehabilitation program (RCRP) 2. Group RCRP and inspiratory muscle training 3. Group RCRP and virtual reality application

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of respiratory functions with simple spirometric measurementsthe preoperative and 10th dayspirometric measurement with spirometry
intraoral pressure measurement (Maximum inspiratory pressure maximum expiratory pressure)the preoperative and 10th dayMaximum inspiratory pressure maximum expiratory pressure

Secondary

MeasureTime frameDescription
Evaluation of functional capacity with 6 minutes walking testthe preoperative and 10th dayWith 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.
Evaluation of anxiety and depressionthe preoperative and 10th dayWith 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).
Dyspnea assessmentthe preoperative and 10th dayWith 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.
Quality of Life assessmentthe preoperative and 10th dayMacNew 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.
Pain assessmentthe preoperative and 10th dayWith 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.
Peak expiratory flowthe preoperative and 10th daypeak flow meter

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026