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Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise

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ClinicalTrials.gov Identifier: NCT01160939
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : July 13, 2010
Sponsor:
Information provided by:
Federal University of São Paulo

July 12, 2010
July 13, 2010
July 13, 2010
November 2004
November 2006   (Final data collection date for primary outcome measure)
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No Changes Posted
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Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Heart Failure
Other: low intensity exercise
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
Same as current
November 2008
November 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
35 Years to 75 Years   (Adult, Older Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01160939
DYYUNIFESP
Yes
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Federal University of São Paulo
Not Provided
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Federal University of São Paulo
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP