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

NCT ID: NCT01160939

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2008-11-30

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Locations

Federal University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

DYYUNIFESP

Identifier Type: -

Identifier Source: org_study_id