Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial

Conditions
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Heart Failure, Transplant; Failure, Heart, Physical Activity

Intervention / Treatment
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* Other: Conventional exercise protocol
* Other: Cycle ergometer exercise protocol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional exercise protocol<br>Conventional global exercise | Other: Conventional exercise protocol<br>* Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position<br>|
| Experimental: Cycle ergometer exercise protocol<br>Stationary cycle ergometer exercise | Other: Cycle ergometer exercise protocol<br>* Stationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test to measure functional capacity change | According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs | 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). | 
| Respiratory muscle strength | By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Invasive mechanical ventilation | Duration of invasive mechanical ventilation will be recorded after cardiac transplantation. | First day after transplantation. | 
| Duration of intensive care unit stay | Duration of stay in intensive care unit (in days) after transplantation will be recorded. | In hospital discharge (after 4 weeks of transplantation). | 
| Hospitalization stay | Duration of stay in the hospital (in days) will be recorded. | In hospital discharge (after 4 weeks of transplantation). |