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

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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Physical Activity; Transplant; Failure, Heart
• Intervention / Treatment: Other: Conventional exercise protocol; Other: Cycle ergometer exercise protocol

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Barbosa; Phone Number: 5511 953578342; Email: carolinebublitz@yahoo.com.br

Study Locations

• Brazil
  • São Paulo, Brazil, 04024002
    • Recruiting
    • Caroline Bublitz Barbosa
    • Contact: Caroline Barbosa
    • Principal Investigator: Isis Begot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional exercise protocol; Conventional global exercise	Other: Conventional exercise protocol; Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
EXPERIMENTAL: Cycle ergometer exercise protocol; Stationary cycle ergometer exercise	Other: 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.

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (ACTUAL): April 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 74619617.3.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No