Physical Capacity in Hodgkin Lymphoma Survivors

Study Overview
=================
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.

Official Title
-----------------
Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors

Conditions
-----------------
Hodgkin Lymphoma, Adult, Cardiovascular Diseases, Radiation Effect, Chemotherapy Effect

Intervention / Treatment
-----------------
* Procedure: Physical Characteristics
* Diagnostic Test: Assessment of Heart rate variability
* Diagnostic Test: Blood Pressure and Cardiac Autonomic Control
* Diagnostic Test: Evaluation of Baroreflex Control
* Diagnostic Test: Cardiac Function and Structure
* Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score
* Diagnostic Test: Blood Assessments
* Diagnostic Test: Physical Capacity
* Procedure: Physical Training


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise training group<br>Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks | Procedure: Physical Characteristics<br>* Body Weight, Height<br>Diagnostic Test: Assessment of Heart rate variability<br>* Holter 24h<br>Diagnostic Test: Blood Pressure and Cardiac Autonomic Control<br>* Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.<br>Diagnostic Test: Evaluation of Baroreflex Control<br>* The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.<br>Diagnostic Test: Cardiac Function and Structure<br>* Echocardiogram<br>Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score<br>* Angiotomography<br>Diagnostic Test: Blood Assessments<br>* Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).<br>Diagnostic Test: Physical Capacity<br>* Cardiopulmonary Exercise Test.<br>Procedure: Physical Training<br>* 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.<br>|
| Sham Comparator: Control Group<br>Patients will be only clinically followed up. They will not perform exercise training. | Procedure: Physical Characteristics<br>* Body Weight, Height<br>Diagnostic Test: Assessment of Heart rate variability<br>* Holter 24h<br>Diagnostic Test: Blood Pressure and Cardiac Autonomic Control<br>* Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.<br>Diagnostic Test: Evaluation of Baroreflex Control<br>* The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.<br>Diagnostic Test: Cardiac Function and Structure<br>* Echocardiogram<br>Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score<br>* Angiotomography<br>Diagnostic Test: Blood Assessments<br>* Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).<br>Diagnostic Test: Physical Capacity<br>* Cardiopulmonary Exercise Test.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Capacity - Peak oxygen consumption (mL/kg/min) | Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes). | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Hate (beat/min) | Post-exercise heart rate will be evaluated by the number of beats in time masurement (one minute). | 4 months | 
| Cardiac Function - Ejection Fraction | Ejection Fraction (EF=ESV-EDV/EDV) combines end systolic (ESV) and diastolic volumes (EDV)(mL) | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxygen Consumption, Physical Training, Heart Hate, Cardioprotection