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

Primary Purpose

Heart Failure, Transplant; Failure, Heart, Physical Activity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conventional exercise protocol
Cycle ergometer exercise protocol
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caroline Bublitz BarbosaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Conventional exercise protocol

Cycle ergometer exercise protocol

Arm Description

Conventional global exercise

Stationary cycle ergometer exercise

Outcomes

Primary Outcome Measures

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
Respiratory muscle strength
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure

Secondary Outcome Measures

Invasive mechanical ventilation
Duration of invasive mechanical ventilation will be recorded after cardiac transplantation.
Duration of intensive care unit stay
Duration of stay in intensive care unit (in days) after transplantation will be recorded.
Hospitalization stay
Duration of stay in the hospital (in days) will be recorded.

Full Information

First Posted
April 4, 2018
Last Updated
April 13, 2018
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03506737
Brief Title
Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation
Official Title
Impact of an Exercise-based Cardiac Rehabilitation Program on Hospitalized Heart Failure Patients Submitted to Cardiac Transplantation: Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Transplant; Failure, Heart, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional exercise protocol
Arm Type
Experimental
Arm Description
Conventional global exercise
Arm Title
Cycle ergometer exercise protocol
Arm Type
Experimental
Arm Description
Stationary cycle ergometer exercise
Intervention Type
Other
Intervention Name(s)
Conventional exercise protocol
Intervention Description
Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
Intervention Type
Other
Intervention Name(s)
Cycle ergometer exercise protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Six-minute walk test to measure functional capacity change
Description
According to the baseline distance walked, we will evaluate the improvement in functional capacity after the period of the rehabilitation programs
Time Frame
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).
Title
Respiratory muscle strength
Description
By manovacuometry, assessing the change in inspiratory muscle pressure and expiratory muscle pressure
Time Frame
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 Measure Information:
Title
Invasive mechanical ventilation
Description
Duration of invasive mechanical ventilation will be recorded after cardiac transplantation.
Time Frame
First day after transplantation.
Title
Duration of intensive care unit stay
Description
Duration of stay in intensive care unit (in days) after transplantation will be recorded.
Time Frame
In hospital discharge (after 4 weeks of transplantation).
Title
Hospitalization stay
Description
Duration of stay in the hospital (in days) will be recorded.
Time Frame
In hospital discharge (after 4 weeks of transplantation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Barbosa
Phone
5511 953578342
Email
carolinebublitz@yahoo.com.br
Facility Information:
Facility Name
Caroline Bublitz Barbosa
City
São Paulo
ZIP/Postal Code
04024002
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Barbosa
First Name & Middle Initial & Last Name & Degree
Isis Begot

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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