Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis

NCT02597985 | Completed

• 1 other identifier: 15-004180
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.

Conditions

Aortic Stenosis

Keywords

Frailty

Outcome Measures

Primary Outcomes (1)

• Change in Score on short physical performance battery (SPPB) test

  Baseline, approximately 1 year

Study Arms (2)

Prehabilitation

ACTIVE COMPARATOR

Will receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score

Other: Prehabilitation

Usual care

PLACEBO COMPARATOR

Will receive usual care

Other: Usual Care

Interventions

Prehabilitation OTHER

Supervised exercise training intervention will include three sessions per week for four weeks at a Mayo Clinic system cardiac rehabilitation facility. The Rochester, Minnesota Cardiac Rehabilitation Program will provide guidance and oversight. Modes of aerobic exercise will include treadmill walking (the primary mode of training) supplemented with non-weight-bearing activities such as stationary cycling and combination arm/leg recumbent exercise (NuStep device), as needed. Intensity will be set using Borg Perceived Exertion Scale (RPE) ratings of 12-14 (somewhat hard), keeping patients below the threshold for more than mild angina.

Prehabilitation

Usual Care OTHER

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligibility for TAVR
• SPPB\<9
• Able to exercise
• Able to come for follow-up visits
• Able to give informed consent

You may not qualify if:

• New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
• Presyncope or syncope as presentation
• Acute coronary syndrome
• Unable to exercise
• Dementia
• Sustained ventricular arrhythmia
• Stroke with neurological deficit
• Advanced Parkinson's
• Participated in an exercise program

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Aortic Valve Stenosis; Frailty

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Mandeep Singh, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: November 5, 2015
• Study Start: October 1, 2015
• Primary Completion: June 17, 2019
• Study Completion: September 10, 2019
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

US (1)