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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03522454|
Recruitment Status : Unknown
Verified October 2020 by Jonathan Afilalo, Jewish General Hospital.
Recruitment status was: Recruiting
First Posted : May 11, 2018
Last Update Posted : October 9, 2020
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|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.|
|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|
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.
- SF36-PF [ Time Frame: 3 months ]Short-Form 36 Physical Functioning (SF36-PF) scale; range 0-100 (higher is better)
- SPPB [ Time Frame: 3 and 6 months ]Short Physical Performance Battery (SPPB) scale; range 0-12 (higher is better)
- 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
- Habitual physical activity (in kcal per week) [ Time Frame: 3, 6, and 12 months ]Modified Paffenbarger activity scale; range 0-upwards (higher is better)
- Frailty [ Time Frame: 3 and 6 months ]Essential Frailty Toolset (EFT) scale; range 0-5 (lower is better)
- Sarcopenia [ Time Frame: 3, 6, and 12 months ]SARC-F scale; range 0-10 (lower is better)
- Fat free mass (in kg) [ Time Frame: 3 and 6 months ]Portable bioimpedance device; biological range (higher is better)
- Phase angle (in degrees) [ Time Frame: 3 and 6 months ]Portable bioimpedance device; biological range (higher is better)
- Handgrip strength (in kg) [ Time Frame: 3 and 6 months ]Jamar dynamometer; range 0-upwards (higher is better)
- Cognitive function [ Time Frame: 3 and 6 months ]Montreal Cognitive Assessment (MoCA) scale; range 0-30 (higher is better)
- 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
- 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
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
|Contact: Sarah Lantagne||514-340-8222 ext email@example.com|
|Jewish General Hospital / McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada, H3T 1E2|
|Contact: Jonathan Afilalo, MD MSc|
|Contact: Sarah Lantagne 514-340-8222 ext 28692 firstname.lastname@example.org|
|Principal Investigator:||Jonathan Afilalo, MD, MSc||Jewish General Hospital|