Hodgkin Lymphoma, Adult, Cardiovascular Diseases, Radiation Effect, Chemotherapy Effect
Conditions
Keywords
Oxygen Consumption, Physical Training, Heart Hate, Cardioprotection
Brief summary
The study aims to investigate if physical capacity obtained in the cardiopulmonary exercise test can predict cardiovascular alterations in Hodgkin Lymphoma (HL) Survivors. In addition, to study the effects of exercise training on physical capacity and cardiovascular responses in these patients.
Detailed description
Hodgkin Lymphoma (HL) is a hematological neoplasia that mainly affects young people. Anthracycline-based chemotherapy, followed or not by mediastinal radiotherapy, substantially improves prognosis in this set of patients. Observational studies have shown that cardiovascular disease is the most non oncologic cause of death in this population. Coronary artery disease (CAD) affects 26% of survivors after 10 years of absence of HL . However, the early intervention and the assessment to predict the cardiovascular risk remain little known. In this study, the investigators will test the hypothesis that physical capacity can predict the cardiovascular alterations in HL Survivors. In addition, exercise training improves physical capacity and heart rate responses in this set of patients.
Interventions
PROCEDUREPhysical Characteristics
Body Weight, Height
DIAGNOSTIC_TESTAssessment of Heart rate variability
Holter 24h
DIAGNOSTIC_TESTBlood Pressure and Cardiac Autonomic Control
Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
DIAGNOSTIC_TESTEvaluation of Baroreflex Control
The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.
DIAGNOSTIC_TESTCardiac Function and Structure
Echocardiogram
DIAGNOSTIC_TESTAssessment of Coronary Anatomy and Calcium Score
Angiotomography
DIAGNOSTIC_TESTBlood Assessments
Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
DIAGNOSTIC_TESTPhysical Capacity
Cardiopulmonary Exercise Test.
PROCEDUREPhysical Training
Aerobic exercise: 48 sessions of 60 minutes: 5 minutes of warm-up, 40 minutes of exercise. Resistance exercise: 10 minutes of exercise and 5 minutes of recovery.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hodgkin Lymphoma Survivors * Over 18 years old * Chemotherapy with anthracycline and mediastinal radiotherapy in the last 5 years or more
Exclusion criteria
* Renal insufficiency * Pregnant women, * Iodinated contrast allergy, * Life expectancy less than 1 year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Capacity - Peak oxygen consumption (mL/kg/min) | 4 months | Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Hate (beat/min) | 4 months | Post-exercise heart rate will be evaluated by the number of beats in time masurement (one minute). |
| Cardiac Function - Ejection Fraction | 4 months | Ejection Fraction (EF=ESV-EDV/EDV) combines end systolic (ESV) and diastolic volumes (EDV)(mL) |
Countries
Brazil
Contacts
Primary ContactLuciana S Santos
Backup ContactMarilia RH Santos, PhD
Outcome results
None listed