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

NCT03955536 | Unknown DMC

• 1 other identifier: UBeykent
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Group routine cardiac rehabilitation program (RCRP)
2. 2.Group RCRP and inspiratory muscle training
3. 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.

Conditions

Open Heart Surgery

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Evaluation of respiratory functions with simple spirometric measurements

  spirometric measurement with spirometry

  the preoperative and 10th day

• intraoral pressure measurement (Maximum inspiratory pressure maximum expiratory pressure)

  Maximum inspiratory pressure maximum expiratory pressure

  the preoperative and 10th day

Secondary Outcomes (6)

• Dyspnea assessment

  the preoperative and 10th day

• Peak expiratory flow

  the preoperative and 10th day

• Evaluation of functional capacity with 6 minutes walking test

  the preoperative and 10th day

• Evaluation of anxiety and depression

  the preoperative and 10th day

• Pain assessment

  the preoperative and 10th day

Study Arms (3)

Group A

ACTIVE COMPARATOR

Routine cardiac rehabilitation program (RCRP)atient education

Other: Group A: Group routine cardiac rehabilitation program (RCRP)

Group B

EXPERIMENTAL

routine cardiac rehabilitation program + virtual reality

Other: Group B: Group RCRP and inspiratory muscle training

Group C

EXPERIMENTAL

RCRP + inspiratory muscle training

Other: Group C: Group RCRP and virtual reality application

Interventions

Group A: Group routine cardiac rehabilitation program (RCRP) OTHER

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 A

Group B: Group RCRP and inspiratory muscle training OTHER

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 B

Group C: Group RCRP and virtual reality application OTHER

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)

Group C

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Beykent: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Beykent University

Istanbul, 34500, Turkey (Türkiye)

Location

Related 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. No abstract available.

  PMID: 27192673 BACKGROUND

• Barros GF, Santos Cda S, Granado FB, Costa PT, Limaco 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. doi: 10.1590/s0102-76382010000400011. English, Portuguese.

  PMID: 21340377 BACKGROUND

• Cacau Lde A, Oliveira GU, Maynard LG, Araujo 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.

  PMID: 23939326 BACKGROUND

• 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. doi: 10.2522/ptj.20050335.

  PMID: 17012641 BACKGROUND

• 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. doi: 10.1016/j.apmr.2005.05.003.

  PMID: 16213233 BACKGROUND

• 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. doi: 10.1590/s0066-782x2009000400005. English, Portuguese, Spanish.

  PMID: 19565135 BACKGROUND

• 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.

  PMID: 26830195 BACKGROUND

• 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.

  PMID: 27154820 BACKGROUND

• Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco 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.

  PMID: 18716482 BACKGROUND

• 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. doi: 10.5935/1678-9741.20120063. English, Portuguese.

  PMID: 23288176 BACKGROUND

• 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.

  PMID: 25528184 BACKGROUND

• 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.

  PMID: 28075500 BACKGROUND

• 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.

  PMID: 23288909 BACKGROUND

Study Officials

• Yasemin Şahbaz

  researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: May 20, 2019
• Study Start: February 1, 2019
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

TU (1)