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Cardiac Rehabilitation in Patients With Refractory Angina

NCT03218891 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-02-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and feasibility of cardiovascular rehabilitation in Patients with refractory angina, evaluate the effect of cardiovascular rehabilitation in patients with angina Refractory, by maximal oxygen consumption (VO2max) and global myocardial ischemic load by Stress Echocardiography; To evaluate the presence of myocardial injury, caused by physical stress, through ultra-sensitive troponin after sessions of aerobic physical activity, evaluating the behavior during the training period; To evaluate the effect of rehabilitation on the modulation of sympathetic activity and inflammation, muscular blood flow and lipid metabolism; To evaluate of the effect of rehabilitation on ventricular function through Stress echocardiography; Detection of ischemic episodes and arrhythmias identified during the Rehabilitation sessions through external cardiac monitoring (telemetry); Evaluate the quality of life assessment through the SF-36 questionnaire, Canadian Cardiovascular Society, the number of symptomatic episodes of ischemia, daily sublingual nitrate intake.

Conditions

  • Refractory Angina

Interventions

BEHAVIORAL

Cardiac Rehabilitation

The physical training program will start shortly after the initial exams have been completed. The physical training protocol will consist of a 12-week duration, with a frequency of 3 weekly sessions of 60 minutes duration each. The intensity will be prescribed from the echocardiogram with effort and cardiopulmonary test. All sessions will be monitored by telemetry and will be distributed as follows: * 5 minutes warm up * 30 to 40 minutes of aerobic exercise (treadmill). The training intensity will be prescribed individually, based on the results of the test results; * 10 minutes of localized exercises; * 5 minutes of relaxation.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Instituto do Coracao

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Luciana Janot de Matos, Dra · Hospital Israelita Albert Einstein

  • Luciana Janot de Matos, Dra · InCor Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2020-07-28
Completion
2022-02-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03218891 on ClinicalTrials.gov