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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03506737
• Other study ID #: 74619617.3.0000.5505
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2018
• Last updated: April 13, 2018
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Federal University of São Paulo
• Contact: Caroline Barbosa
• Phone: 5511 953578342
• Email: carolinebublitz[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Physical Activity
• Transplant; Failure, Heart

Intervention

Other:
• Conventional exercise protocol
Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
• Cycle 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.

Locations

Country	Name	City	State
Brazil	Caroline Bublitz Barbosa	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Invasive mechanical ventilation	Duration of invasive mechanical ventilation will be recorded after cardiac transplantation.	First day after transplantation.
Secondary	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).
Secondary	Hospitalization stay	Duration of stay in the hospital (in days) will be recorded.	In hospital discharge (after 4 weeks of transplantation).