Clinical trial NCT03955536: Comparison of the Effects of Different Physiotherapy and Rehabilitation Methods on Open Heart Surgery
Official title: Comparison of the Effects of Different Physiotherapy and Rehabilitation Methods in Phase I Following Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Open Heart Surgery
Keywords: Cardiac Rehabilitation
Virtual Reality
Respiratory Muscle Training
Open Heart Surgery
Lead sponsor: University of Beykent
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2019-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of respiratory functions with simple spirometric measurements
timeFrame: the preoperative and 10th day
measure: intraoral pressure measurement (Maximum inspiratory pressure maximum expiratory pressure)
timeFrame: the preoperative and 10th day
Secondary outcomes:
measure: Dyspnea assessment
timeFrame: the preoperative and 10th day
measure: Peak expiratory flow
timeFrame: the preoperative and 10th day
measure: Evaluation of functional capacity with 6 minutes walking test
timeFrame: the preoperative and 10th day
measure: Evaluation of anxiety and depression
timeFrame: the preoperative and 10th day
measure: Pain assessment
timeFrame: the preoperative and 10th day
measure: Quality of Life assessment
timeFrame: the preoperative and 10th day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beykent University
Study officials:
affiliation: researcher
name: Yasemin Şahbaz
role: PRINCIPAL_INVESTIGATOR
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