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

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT01160939
• Lead Sponsor: Federal University of São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2006-11
• Study Completion: 2008-11
• Status Verified: 2009-11
• Study First Submitted: 2010-07-12
• Study First Submitted QC: 2010-07-12
• Last Update Submitted: 2010-07-12
• Study First Posted: 2010-07-13
• Last Update Posted: 2010-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (1)

Federal University of Sao Paulo; 🇧🇷 Sao paulo, Brazil