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

Open Heart Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03955536
• Other study ID #: UBeykent
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2020
• Source: University of Beykent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: November 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Open Heart Surgery

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Turkey	Beykent University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
University of Beykent	Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (13)

Alexander JH, Smith PK. Coronary-Artery Bypass Grafting. N Engl J Med. 2016 May 19;374(20):1954-64. doi: 10.1056/NEJMra1406944. Review. — View Citation

Barros GF, Santos Cda S, Granado FB, Costa PT, Límaco RP, Gardenghi G. Respiratory muscle training in patients submitted to coronary arterial bypass graft. Rev Bras Cir Cardiovasc. 2010 Oct-Dec;25(4):483-90. English, Portuguese. — View Citation

Cacau Lde A, Oliveira GU, Maynard LG, Araújo Filho AA, Silva WM Jr, Cerqueria Neto ML, Antoniolli AR, Santana-Filho VJ. The use of the virtual reality as intervention tool in the postoperative of cardiac surgery. Rev Bras Cir Cardiovasc. 2013 Jun;28(2):281-9. doi: 10.5935/1678-9741.20130039. — View Citation

Chuang TY, Sung WH, Chang HA, Wang RY. Effect of a virtual reality-enhanced exercise protocol after coronary artery bypass grafting. Phys Ther. 2006 Oct;86(10):1369-77. — View Citation

Chuang TY, Sung WH, Lin CY. Application of a virtual reality-enhanced exercise protocol in patients after coronary bypass. Arch Phys Med Rehabil. 2005 Oct;86(10):1929-32. — View Citation

Ferreira PE, Rodrigues AJ, Evora PR. Effects of an inspiratory muscle rehabilitation program in the postoperative period of cardiac surgery. Arq Bras Cardiol. 2009 Apr;92(4):275-82. English, Portuguese, Spanish. — View Citation

Ghoneim MM, O'Hara MW. Depression and postoperative complications: an overview. BMC Surg. 2016 Feb 2;16:5. doi: 10.1186/s12893-016-0120-y. Review. — View Citation

Gomes Neto M, Martinez BP, Reis HF, Carvalho VO. Pre- and postoperative inspiratory muscle training in patients undergoing cardiac surgery: systematic review and meta-analysis. Clin Rehabil. 2017 Apr;31(4):454-464. doi: 10.1177/0269215516648754. Epub 2016 Jul 10. Review. — View Citation

Herdy AH, Marcchi PL, Vila A, Tavares C, Collaço J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152. — View Citation

Matheus GB, Dragosavac D, Trevisan P, Costa CE, Lopes MM, Ribeiro GC. Inspiratory muscle training improves tidal volume and vital capacity after CABG surgery. Rev Bras Cir Cardiovasc. 2012 Jul-Sep;27(3):362-9. English, Portuguese. — View Citation

Poole L, Kidd T, Leigh E, Ronaldson A, Jahangiri M, Steptoe A. Psychological distress and intensive care unit stay after cardiac surgery: The role of illness concern. Health Psychol. 2015 Mar;34(3):283-7. doi: 10.1037/hea0000183. Epub 2014 Dec 22. — View Citation

Spiroski D, Andjic M, Stojanovic OI, Lazovic M, Dikic AD, Ostojic M, Beleslin B, Kostic S, Zdravkovic M, Lovic D. Very short/short-term benefit of inpatient/outpatient cardiac rehabilitation programs after coronary artery bypass grafting surgery. Clin Cardiol. 2017 May;40(5):281-286. doi: 10.1002/clc.22656. Epub 2017 Jan 11. — View Citation

Valkenet K, de Heer F, Backx FJ, Trappenburg JC, Hulzebos EH, Kwant S, van Herwerden LA, van de Port IG. Effect of inspiratory muscle training before cardiac surgery in routine care. Phys Ther. 2013 May;93(5):611-9. doi: 10.2522/ptj.20110475. Epub 2013 Jan 3. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of respiratory functions with simple spirometric measurements	spirometric measurement with spirometry	the preoperative and 10th day
Primary	intraoral pressure measurement (Maximum inspiratory pressure maximum expiratory pressure)	Maximum inspiratory pressure maximum expiratory pressure	the preoperative and 10th day
Secondary	Dyspnea assessment	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
Secondary	Peak expiratory flow	peak flow meter	the preoperative and 10th day
Secondary	Evaluation of functional capacity with 6 minutes walking test	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
Secondary	Evaluation of anxiety and depression	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
Secondary	Pain assessment	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
Secondary	Quality of Life assessment	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