Physical Capacity in Hodgkin Lymphoma Survivors

April 28, 2026 updated by: University of Sao Paulo General Hospital

Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05403-900
        • Luciana de Souza Santos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Carlos E Negrao, PhD, Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2017

Primary Completion (Actual)

October 21, 2022

Study Completion (Actual)

October 21, 2023

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 432715154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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