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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01160939
First received: July 12, 2010
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Failure
Other: low intensity exercise

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Supportive Care
Official Title: Assessment and Monitoring of Patients in Medium-term Heart Transplant Candidates Undergoing Low-intensity Exercise

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Enrollment: 21
Study Start Date: November 2004
Study Completion Date: November 2008
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01160939

Locations
Brazil
Federal University of Sao Paulo
Sao paulo, Brazil, 04023-002
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01160939     History of Changes
Other Study ID Numbers: DYYUNIFESP
Study First Received: July 12, 2010
Last Updated: July 12, 2010
Health Authority: Brazil: Research and Ethics Committee/ UNIFESP

Keywords provided by Federal University of São Paulo:
Exercise
heart failure
rehabilitation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014