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Prehabilitation and Heart Valve Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04993963
Recruitment Status : Completed
First Posted : August 6, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Riphah International University

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.

Condition or disease Intervention/treatment Phase
Valvular Heart Disease Other: Cycle Ergometery Training (Prehabilitation) Other: Control Standard Group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : August 15, 2021
Actual Study Completion Date : August 30, 2021

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)




Primary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04993963


Locations
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Pakistan
Pakistan Institute of medical sciences (PIMS)
Islamabad, Punjab, Pakistan, 46000
Sponsors and Collaborators
Riphah International University
Investigators
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Principal Investigator: Mehwish Waseem, MSPT(CPPT) Riphah International University
Publications:
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Responsible Party: Riphah International University
ClinicalTrials.gov Identifier: NCT04993963    
Other Study ID Numbers: Rec/00881 Tayyaba kiran
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Riphah International University:
prehabilitation
quality of recovery
heart valve surgery
Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases