Clinical trial NCT04993963: Prehabilitation and Heart Valve Surgery
Official title: Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease
Keywords: prehabilitation
quality of recovery
heart valve surgery
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-08-06
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery
timeFrame: After 6 weeks, 1 month after CABG
measure: Clinical Frailty Score
timeFrame: After 6 weeks, 1 month after CABG
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Institute of medical sciences (PIMS)
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Milder DA, Pillinger NL, Kam PCA. The role of prehabilitation in frail surgical patients: A systematic review. Acta Anaesthesiol Scand. 2018 Nov;62(10):1356-1366. doi: 10.1111/aas.13239. Epub 2018 Aug 10.
citation: McCann M, Stamp N, Ngui A, Litton E. Cardiac Prehabilitation. J Cardiothorac Vasc Anesth. 2019 Aug;33(8):2255-2265. doi: 10.1053/j.jvca.2019.01.023. Epub 2019 Jan 12.
citation: Steinmetz C, Bjarnason-Wehrens B, Baumgarten H, Walther T, Mengden T, Walther C. Prehabilitation in patients awaiting elective coronary artery bypass graft surgery - effects on functional capacity and quality of life: a randomized controlled trial. Clin Rehabil. 2020 Oct;34(10):1256-1267. doi: 10.1177/0269215520933950. Epub 2020 Jun 16.
citation: Norris CM, Close JCT. Prehabilitation for the Frailty Syndrome: Improving Outcomes for Our Most Vulnerable Patients. Anesth Analg. 2020 Jun;130(6):1524-1533. doi: 10.1213/ANE.0000000000004785.