Heart Failure, Physical Activity, Transplant; Failure, Heart
Conditions
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.
Interventions
OTHERConventional exercise protocol
Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
OTHERCycle ergometer exercise protocol
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.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six-minute walk test to measure functional capacity change | 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). | According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs |
| Respiratory muscle strength | 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) | By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Invasive mechanical ventilation | First day after transplantation. | Duration of invasive mechanical ventilation will be recorded after cardiac transplantation. |
| Duration of intensive care unit stay | In hospital discharge (after 4 weeks of transplantation). | Duration of stay in intensive care unit (in days) after transplantation will be recorded. |
| Hospitalization stay | In hospital discharge (after 4 weeks of transplantation). | Duration of stay in the hospital (in days) will be recorded. |
Countries
Brazil
Contacts
Primary ContactCaroline Barbosa
Outcome results
None listed