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The PERFORM-TAVR Trial (PERFORM-TAVR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03522454
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
University of British Columbia
McGill University Health Centre/Research Institute of the McGill University Health Centre
St. Boniface General Hospital Research Centre
Montreal Heart Institute
Hamilton Health Sciences Corporation
Ottawa Heart Institute Research Corporation
St. Michael's Hospital, Toronto
Sunnybrook Research Institute
Hopital du Sacre-Coeur de Montreal
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Jonathan Afilalo, Jewish General Hospital

Brief Summary:
The PERFORM-TAVR trial (Protein and Exercise to Reverse Frailty in OldeR Men and women undergoing Transcatheter Aortic Valve Replacement) is a multicenter randomized clinical trial with a parallel-group design. The investigators will screen consecutive patients ≥70 years of age before TAVR and enrol those that have evidence of physical frailty defined by an SPPB score ≤8. The investigators will randomly allocate 250 patients to receive a multi-faceted intervention consisting of a home-based exercise program and a protein-rich oral nutritional supplement or usual lifestyle counselling. The primary endpoint will be the change in SPPB score at 12 weeks.

Condition or disease Intervention/treatment Phase
Frail Elderly Exercise Dietary Supplements Postoperative Care Rehabilitation Transcatheter Aortic Valve Replacement Dietary Supplement: Protein-rich oral nutritional supplement Behavioral: Home-based supervised exercise program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The outcome assessor who will perform the 3 and 6 month visits will be blinded to the participant's assigned intervention.
Primary Purpose: Treatment
Official Title: Protein and Exercise to Reverse Frailty in OlderR Men and Women Undergoing TAVR: The PERFORM-TAVR Trial
Actual Study Start Date : March 15, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
Intervention group: Combination of a protein-rich oral nutritional supplement consumed twice daily for 4 weeks pre-TAVR and 12 weeks after the patient is discharged home post-TAVR, and a home-based supervised exercise program that combines walking and weight-bearing exercises to build strength and balance performed for 12 weeks after the patient is discharged home post-TAVR.
Dietary Supplement: Protein-rich oral nutritional supplement
Ready-to-drink beverage containing 20 g protein and 1.5 g hydroxymethylbutyrate (HMB) per serving, consumed twice daily.

Behavioral: Home-based supervised exercise program
WEBB (Weight-bearing Exercise for Better Balance) program combining walking and weight-bearing exercises to build strength and balance, administered by a trained therapist at the participant's home.

No Intervention: Lifestyle counselling group
Lifestyle counselling group: Recommendation to perform moderate-intensity aerobic activity at least 30 minutes 5 days per week as tolerated and eat a balanced diet based on the AHA/ACC Guideline on Lifestyle Management.



Primary Outcome Measures :
  1. SPPB [ Time Frame: 3 months ]
    Short Physical Performance Battery (SPPB) scale; range 0-12 (higher is better)


Secondary Outcome Measures :
  1. SPPB [ Time Frame: 6 months ]
    Short Physical Performance Battery (SPPB) scale; range 0-12 (higher is better)

  2. Health-related quality of life [ Time Frame: 3, 6, and 12 months ]
    Short Form Health Survey (SF-36) scale; population-standardized to mean score of 50 with standard deviation of 10 (higher is better) for the 8 section scores and 2 summary scores

  3. Habitual physical activity (in kcal per week) [ Time Frame: 3, 6, and 12 months ]
    Modified Paffenbarger activity scale; range 0-upwards (higher is better)

  4. Frailty [ Time Frame: 3 and 6 months ]
    Essential Frailty Toolset (EFT) scale; range 0-5 (lower is better)

  5. Sarcopenia [ Time Frame: 3, 6, and 12 months ]
    SARC-F scale; range 0-10 (lower is better)

  6. Fat free mass (in kg) [ Time Frame: 3 and 6 months ]
    Portable bioimpedance device; biological range (higher is better)

  7. Phase angle (in degrees) [ Time Frame: 3 and 6 months ]
    Portable bioimpedance device; biological range (higher is better)

  8. Handgrip strength (in kg) [ Time Frame: 3 and 6 months ]
    Jamar dynamometer; range 0-upwards (higher is better)

  9. Cognitive function [ Time Frame: 3 and 6 months ]
    Montreal Cognitive Assessment (MoCA) scale; range 0-30 (higher is better)

  10. Number of participants suffering composite safety endpoint [ Time Frame: 3 and 6 months ]
    All-cause mortality, injurious fall, acute kidney injury, or readmission for worsening angina, heart failure, or arrhythmia

  11. Number of participants suffering death from any cause [ Time Frame: 3, 6, and 12 months ]
    All-cause mortality assessed by medical records and telephone contact



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥70 years
  • Undergoing TAVR
  • Physically frail: SPPB score </= 8 pre-TAVR
  • Signed informed consent

Exclusion Criteria:

  • Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
  • Uncontrolled diabetes with HbA1C >8.5%
  • Glomerular filtration rate (GFR) <30 mL/min/1.73 m2 by the MDRD equation
  • Cirrhosis
  • Allergy to ingredient in beverage
  • Inability to safely ingest beverage by mouth
  • Inability to walk without human assistance or high-risk of falls
  • Moderate-to-severe cognitive impairment
  • Significant language barrier
  • Living too far for home visits

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): NCT03522454


Contacts
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Contact: Cynthia Dion 514-340-8222 ext 28692 cynthia.dion@ladydavis.ca

Locations
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Canada, Quebec
Jewish General Hospital / McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Jonathan Afilalo, MD MSc         
Contact: Cynthia Dion    514-340-8222 ext 28692    cynthia.dion@ladydavis.ca   
Sponsors and Collaborators
Jewish General Hospital
University of British Columbia
McGill University Health Centre/Research Institute of the McGill University Health Centre
St. Boniface General Hospital Research Centre
Montreal Heart Institute
Hamilton Health Sciences Corporation
Ottawa Heart Institute Research Corporation
St. Michael's Hospital, Toronto
Sunnybrook Research Institute
Hopital du Sacre-Coeur de Montreal
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Principal Investigator: Jonathan Afilalo, MD, MSc Jewish General Hospital
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Responsible Party: Jonathan Afilalo, Principal Investigator, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT03522454    
Other Study ID Numbers: 378469
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Jonathan Afilalo, Jewish General Hospital:
Frailty
TAVR