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Pre-habilitation of Patients Scheduled for Cardiac Valve Surgery

NCT03571906 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-06-28

No results posted yet for this study

Summary

Cardiac rehabilitation (CR) is an integral part of cardiovascular disease management incorporating aspects of scientifically constructed appropriate physical exercise. CR has been repeatedly shown to significantly improve functional capacity, depression and wellbeing, even following short term interventions. Functional capacity is closely related to frailty, a key prognostic factor in subjects undergoing cardiac surgery. We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Our hypothesis is that the Prehab group will improve their functional capacity to a greater degree than the usual care group, possibly associated with better clinical outcomes.

Conditions

  • Valvular Heart Disease

Interventions

BEHAVIORAL

Tele - Cardiac Pre-Rehabilitation

We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery Adherence to the rehab program will be assessed and a structured motivational program and follow-up will be provided in order to maximize goal completion.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-07-31
Completion
2019-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03571906 on ClinicalTrials.gov