Recruiting

Exercise & Protein

Sponsor:

Jewish General Hospital

Code:

NCT03522454

Conditions

Frail Elderly

Exercise

Dietary Supplements

Postoperative Care

Rehabilitation

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Protein-rich oral nutritional supplement

Home-based supervised exercise program

Study Details

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 or an SF36-PF score ≤55. The investigators will randomly allocate 200 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 SF36-PF score at 12 weeks.

Conditions

Frail Elderly

Exercise

Dietary Supplements

Postoperative Care

Rehabilitation

Study ID

NCT03522454

Start date

Mar 15, 2019

Status verified date

Oct, 2020

Completion date

Dec 1, 2022

Anticipated

Primary completion date

Dec 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥70 years
  • Undergoing TAVR
  • Physically frail: SPPB score ≤8 or SF36-PF score ≤ 55 pre-TAVR
  • Informed written or verbal consent

Exclusion Criteria:

  • Decompensated or non-ambulatory class IV symptoms of angina, dyspnea, claudication
  • Uncontrolled diabetes with HbA1C >8.5% (or mean glucose ≥11.0 in the absence of a HbA1C test)
  • 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
  • COVID positive or suspected at screening

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Protein-rich oral nutritional supplement

Ready-to-drink beverage containing 20 g protein and 1.5 g hydroxymethylbutyrate (HMB) per serving, consumed twice daily.

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.

Primary outcome measure

  • SF36-PF [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Sarah Lantagne

514-340-8222sarah.lantagne@ladydavis.ca

Locations

Jewish General Hospital / McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Sarah Lantagne

514-340-8222sarah.lantagne@ladydavis.ca

More Information

Sponsor

Jewish General Hospital

Last update posted

Oct 9, 2020

Last verified

Oct, 2020

Keywords

  • Frailty
  • TAVR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jewish General Hospital on 2020-10-09.