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

NCT03506737 | Unknown DMC

• 1 other identifier: 74619617.3.0000.5505
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Transplant; Failure, Heart; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Invasive mechanical ventilation

  First day after transplantation.

• Duration of intensive care unit stay

  In hospital discharge (after 4 weeks of transplantation).

• Hospitalization stay

  In hospital discharge (after 4 weeks of transplantation).

Study Arms (2)

Conventional exercise protocol

EXPERIMENTAL

Conventional global exercise

Other: Conventional exercise protocol

Cycle ergometer exercise protocol

EXPERIMENTAL

Stationary cycle ergometer exercise

Other: Cycle ergometer exercise protocol

Interventions

Conventional exercise protocol OTHER

Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position

Conventional exercise protocol

Cycle ergometer exercise protocol OTHER

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.

Cycle ergometer exercise protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Caroline Bublitz Barbosa

São Paulo, 04024002, Brazil

RECRUITING

MeSH Terms

Conditions

Heart Failure; Motor Activity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Caroline Barbosa

CONTACT

5511 953578342; carolinebublitz@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 24, 2018
• Study Start: January 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 24, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)