Prehabilitation and Heart Valve Surgery

NCT04993963 | Completed DMC

• 1 other identifier: Rec/00881 Tayyaba kiran
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Valvular Heart Disease

Keywords

prehabilitation; quality of recovery; heart valve surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Cycle Ergometery Training (Prehabilitation)

EXPERIMENTAL

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)

Control Standard Group

ACTIVE COMPARATOR

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

Other: Control Standard Group

Interventions

Cycle Ergometery Training (Prehabilitation) 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

Cycle Ergometery Training (Prehabilitation)

Control Standard Group OTHER

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

Control Standard Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Pakistan Institute of medical sciences (PIMS)

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 30094821 BACKGROUND

• 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.

  PMID: 30765210 BACKGROUND

• 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.

  PMID: 32546065 BACKGROUND

• 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.

  PMID: 32384342 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mehwish Waseem, MSPT(CPPT)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 6, 2021
• Study Start: February 1, 2021
• Primary Completion: August 15, 2021
• Study Completion: August 30, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)