Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
low intensity exercise
Sponsored by

About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Exercise, heart failure, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- heart failure severe, awaiting heart transplantation
Exclusion Criteria:
- decompensated heart failure
- vasoactive drugs
- unstable angina
- severe stenosis or insufficiency valvular
- recent surgery
- morbid obesity
Sites / Locations
- Federal University of Sao Paulo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01160939
First Posted
July 12, 2010
Last Updated
July 12, 2010
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01160939
Brief Title
Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
Official Title
Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives: To study the behavior and cardiovascular safety protocol to the front low-intensity exercise in patients with heart failure (HF) severe, awaiting heart transplantation. Methods: The investigators studied 21 patients with severe HF on the list for a heart transplant at the University Hospital of UNIFESP. After evaluation, patients underwent exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3. walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between 2-6 metabolic equivalents. These also were followed for an average period of 17 months as the clinical complications and death. Results: From the patients studied, three were not able to perform the full protocol, and the variables body mass index, maximal inspiratory and expiratory pressure measurement (Pimáx and Pemáx, cmH2O) and number of previous admissions, showed the most divergent behavior of the sample studied. A greater increase in heart rate, double product and scale of perceived exertion during step 5 was observed during the protocol. Blood pressure levels showed little change between stages, and there was no arrhythmias incidence increase (kappa = 0.552) compared to effort. A positive correlation scale was perceived in exertion walking distance of 200m, with systolic blood pressure (r = 0.4, p = 0.02). Overall observed lower values of maximal inspiratory pressure and increased blood pressure and elevated heart rate in patients with death outcome. Conclusion: Cardiovascular behavior against exercise protocol was well tolerated and safe, but suggests need for monitoring. Information collected at initial clinical evaluation associated with decompensation and death, and may help stratify these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Exercise, heart failure, rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
low intensity exercise
Intervention Description
exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3. walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between 2-6 metabolic equivalents
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
Inclusion Criteria:
heart failure severe, awaiting heart transplantation
Exclusion Criteria:
decompensated heart failure
vasoactive drugs
unstable angina
severe stenosis or insufficiency valvular
recent surgery
morbid obesity
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao paulo
ZIP/Postal Code
04023-002
Country
Brazil
12. IPD Sharing Statement
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Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
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