Prehabilitation and Heart Valve Surgery

NCT ID: NCT04993963

Last Updated: 2021-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-08-30

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.

Conditions

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Valvular Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Cycle Ergometery Training (Prehabilitation)

Intervention Type OTHER

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)

Group Type ACTIVE_COMPARATOR

Control Standard Group

Intervention Type OTHER

Breathing exercise 15 Reps and Walk (10-15 minutes)

Interventions

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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

Intervention Type OTHER

Control Standard Group

Breathing exercise 15 Reps and Walk (10-15 minutes)

Intervention Type OTHER

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mehwish Waseem, MSPT(CPPT)

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Pakistan Institute of medical sciences (PIMS)

Islamabad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30094821 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30765210 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32546065 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32384342 (View on PubMed)

Other Identifiers

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Rec/00881 Tayyaba kiran

Identifier Type: -

Identifier Source: org_study_id

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