Clinical trial NCT03506737: Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation
Official title: Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Transplant; Failure, Heart
Physical Activity
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effects of an early-based cardiac rehabilitation program on the functional capacity, inspiratory muscular strength and clinical outcomes in hospitalized heart failure patients before and after heart transplantation. Method: 30 hospitalized heart failure patients awaiting cardiac transplantation will be selected and randomized in 2 groups: conventional group (n = 15) - conventional exercise protocol: breathing exercises and global active exercises of upper and lower limbs in the sitting position; and Intervention group (n = 15) - cycle ergometer exercise protocol: each session consists of cycling on a stationary bicycle in the seated position for 20 minutes. In both groups, the exercise protocols will be applied twice a day until the hospital discharge, always supervised by a physiotherapist and a doctor. The evaluation procedures in all patients of the research will be: functional capacity measured by the 6 minute walk test and inspiratory muscle strength measured by manovacuometry. Evaluations will be repeated in 3 distinct moments: after 24h of hospital admission and/or clinical stabilization; before transplantation and after transplantation in hospital discharge.


Eligibility criteria: Inclusion Criteria:

* Heart Failure diagnosis determined by clinical presentation and confirmed on echocardiography by clinicians, with a left ventricular ejection fraction (LVEF) \< 40%
* New York Heart Association (NYHA) classes III and IV.

Exclusion Criteria:

* chronic lung disease confirmed by pulmonary function testing
* unstable angina pectoris and acute coronary syndromes
* dialysis
* neuromuscular and psychiatric conditions that interfere in exercise

Primary outcomes:
measure: Six-minute walk test to measure functional capacity change
timeFrame: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation).
measure: Respiratory muscle strength
timeFrame: After 24 hours of hospital admission or clinical stabilization; before transplantation (after 4 weeks of rehabilitation program) and in hospital discharge (after 4 weeks of transplantation)
Secondary outcomes:
measure: Invasive mechanical ventilation
timeFrame: First day after transplantation.
measure: Duration of intensive care unit stay
timeFrame: In hospital discharge (after 4 weeks of transplantation).
measure: Hospitalization stay
timeFrame: In hospital discharge (after 4 weeks of transplantation).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Caroline Bublitz Barbosa
Study officials:
References: