Prehabilitation and Heart Valve Surgery

September 29, 2021 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan, 46000
        • Pakistan Institute of Medical Sciences (PIMS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cycle Ergometery Training (Prehabilitation)
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)
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
Active Comparator: Control Standard Group
Breathing exercise 15 Reps and Walk (10-15 minutes)
Other: Control Standard Group
Breathing exercise 15 Reps and Walk (10-15 minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery
Time Frame: After 6 weeks, 1 month after CABG
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
Time Frame: After 6 weeks, 1 month after CABG
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

August 15, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

August 5, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rec/00881 Tayyaba kiran

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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