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Clinical Trials/NCT04636255
NCT04636255
Unknown
N/A

Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors

University of Sao Paulo General Hospital1 site in 1 country40 target enrollmentOctober 21, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hodgkin Lymphoma, Adult
Sponsor
University of Sao Paulo General Hospital
Enrollment
40
Locations
1
Primary Endpoint
Physical Capacity - Peak oxygen consumption (mL/kg/min)
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 21, 2017
End Date
October 21, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Physical Capacity - Peak oxygen consumption (mL/kg/min)

Time Frame: 4 months

Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes).

Secondary Outcomes

  • Heart Hate (beat/min)(4 months)
  • Cardiac Function - Ejection Fraction(4 months)

Study Sites (1)

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