Prehabilitation and Heart Valve Surgery

Study Overview
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Brief Summary
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To evaluate the impact of prehabilitation on quality of recovery in heart valve surgery. To evaluate the effects of Mild to moderate valvular diseases with Newyork Heart Association (NYHA) grade I and II . Previous studies were designed to target on Coronary artery bypass graft surgery (CABGs) patients no specifically heart valve surgery patients was studied so this study cover this aspect as well so from the outcomes of this study we will determine the prehabilitation effects on valvular surgery patients.

Detailed Description
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A review stated that  the concept of prehabilitation has entered the forefront which encompasses multidisciplinary interventions to improve health and lessen the incidence of postoperative decline. In the previous study held in pre-operative assessment clinic between March 2016 and August 2016, evaluated that PREHAB programme for frail patients undergoing CABG or Valve surgery may be able to improve functional ability and reduce hospital length of stay for those patients undergoing cardiac surgery. previous other studies, parental study which is PREQUEL study recruitment started in July 2018 expect patient recruitment and 3 months of follow-up will be completed in June 2022 then their analysis will be done. To improve functional and enhance the resources and postoperative recovery, prehabilitation plays a very cardial role. In some studies, it has been noticed that preoperative improvement in physical fitness, improve functional capacity all this is the part of the model for improving post-surgery recovery, this could play a vital role.

Official Title
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Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.

Conditions
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Valvular Heart Disease

Intervention / Treatment
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* Other: Cycle Ergometery Training (Prehabilitation)
* Other: Control Standard Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients awaiting heart valve surgery for repair or replacement Both gender Mild to moderate valvular diseases NYHA grade I and II Pre-frail to moderately frail patients with a CFS of 4-6 Patients with an estimated 6-8 weeks of surgical waiting list time. Able to perform 6MWT at baseline with RPE<13 Exclusion Criteria: Patients with severe left ventricular obstructive disease (severe aortic or mitral stenosis and dynamic left ventricular outflow obstruction). Patients with unstable or recently unstable cardiac syndrome Other than valve surgeries e.g. CABG Hospitalization for arrhythmias/ congestive heart failure
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cycle Ergometery Training (Prehabilitation)<br>Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown) Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale | Other: Cycle Ergometery Training (Prehabilitation)<br>* Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale 20-30 min/session/day (intermittent of exercise 2-3 mint, followed by 1-2 min of active recovery) Cool down (5 minutes) AROM +Body stretch<br>|
| Active Comparator: Control Standard Group<br>Breathing exercise 15 Reps and Walk (10-15 minutes) | Other: Control Standard Group<br>* Breathing exercise 15 Reps and Walk (10-15 minutes)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery | 15-item Quality of Recovery (QoR-15) is one of the standardized outcomes for assessing patient comfort after surgery. The QoR-15 score includes the items measuring pain, physical comfort, physical independence, psychological support, and emotional state. The QoR-15 score runs from 0 to 150. Higher scores indicate better Quality of life. | After 6 weeks, 1 month after CABG | 
| Clinical Frailty Score | Frailty is a valid and clinically important construct that is recognizable by physicians. Clinical judgments about frailty can yield useful predictive information. Initial Clinical Frailty Scale assessment had access to diagnoses and assessments related to these variables and other measures of comorbidity, function, and associated features that inform clinical judgments about the severity of frailty. It was modified to a 9-point scale to include very severely frail and terminally ill. It evaluates specific domains, including comorbidity, function, and cognition, to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). | After 6 weeks, 1 month after CABG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prehabilitation, quality of recovery, heart valve surgery