Prehabilitation and Heart Valve Surgery
Primary Purpose
Valvular Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Cycle Ergometery Training (Prehabilitation)
Control Standard Group
Sponsored by
About this trial
This is an interventional treatment trial for Valvular Heart Disease focused on measuring prehabilitation, quality of recovery, heart valve surgery
Eligibility 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
Sites / Locations
- Pakistan Institute of medical sciences (PIMS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cycle Ergometery Training (Prehabilitation)
Control Standard Group
Arm Description
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
Breathing exercise 15 Reps and Walk (10-15 minutes)
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04993963
First Posted
August 5, 2021
Last Updated
September 29, 2021
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT04993963
Brief Title
Prehabilitation and Heart Valve Surgery
Official Title
Impact of Prehabilitation on the Quality of Recovery (QoR) After Heart Valve Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
prehabilitation, quality of recovery, heart valve surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycle Ergometery Training (Prehabilitation)
Arm Type
Experimental
Arm Description
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
Arm Title
Control Standard Group
Arm Type
Active Comparator
Arm Description
Breathing exercise 15 Reps and Walk (10-15 minutes)
Intervention Type
Other
Intervention Name(s)
Cycle Ergometery Training (Prehabilitation)
Intervention Description
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
Intervention Name(s)
Control Standard Group
Intervention Description
Breathing exercise 15 Reps and Walk (10-15 minutes)
Primary Outcome Measure Information:
Title
Quality of recovery
Description
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.
Time Frame
After 6 weeks, 1 month after CABG
Title
Clinical Frailty Score
Description
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).
Time Frame
After 6 weeks, 1 month after CABG
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehwish Waseem, MSPT(CPPT)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Institute of medical sciences (PIMS)
City
Islamabad
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30094821
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.
Results Reference
background
PubMed Identifier
30765210
Citation
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.
Results Reference
background
PubMed Identifier
32546065
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.
Results Reference
background
PubMed Identifier
32384342
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.
Results Reference
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Prehabilitation and Heart Valve Surgery
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