Prehabilitation and Heart Valve Surgery

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993963
• Other study ID #: Rec/00881 Tayyaba kiran
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 30, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Other:
• Cycle Ergometery Training (Prehabilitation)
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
• Control Standard Group
Breathing exercise 15 Reps and Walk (10-15 minutes)

Locations

Country	Name	City	State
Pakistan	Pakistan Institute of medical sciences (PIMS)	Islamabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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