Effects of Exercise Training in Survivors of Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorNorwegian School of Sport Sciences
About this trial
This study aims to compare the effects of aerobic exercise with or without addition of resistance exercise to usual care in individuals treated with anthracyclines for lymphomas and to compare exercise effects to age- and sex-matched individuals with no prior history of malignant diseases.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Listed in relevant registers
Confirmed lymphoma diagnosis (i.e., Hodgkin lymphoma and aggressive non-Hodgkin lymphoma)
Completed treatment in the past two to five years without relapse or second cancer
Previous anthracycline treatment with or without mediastinal radiation
Disqualifiers
Relapse since diagnosis
A history, or current presence, of another diagnosis of invasive cancer of any kind
Presence of any uncontrolled- or recent cardiovascular disease
Has undergone heart surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic Exercise
BehavioralParticipants receive twice weekly supervised aerobic treadmill-based exercise sessions for five months. Session duration varies from 20 to 60 minutes, including warm-up, with exercise intensity ranging from 60 to 95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate) will be determined by the CPET performed by certified exercise physiologists at baseline.The exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. This intervention is also given to the Active Comparator group (i.e. non-cancer reference group)
Combined Aerobic and Resistance Exercise
BehavioralTwice weekly, supervised combined aerobic and resistance exercise sessions will be offered to participants. Participants randomized to the combined aerobic and resistance training group will follow the same aerobic exercise prescription as described for the Aerobic Exercise arm. In addition, participants in this group will perform five resistance exercises after the aerobic sessions. The resistance exercises will be leg press, knee extension, and calf rise, followed by seated row and chest press. Following familiarization, the training load will progressively increase following a linear periodization model throughout the intervention. exercise prescription will be sequenced so that the exercise intensity and -duration of each exercise varies within each week, leading to an accumulative increase in weekly exercise volume throughout the intervention. Only Lymphoma participants can be randomized to this arm.
Treatment groups
280 Participants
are divided into 4 treatment groupsGroup A: Aerobic ExerciseExperimental treatment 1 intervention
Group B: Combined Aerobic and Resistance ExerciseExperimental treatment 1 intervention
Group C: Standard CareNo intervention 0 interventions
Group D: Reference Aerobic ExerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
VO2peak
Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test
Time frame
Baseline, five months from baseline (i.e. end of intervention) and 2 years from baselineSecondary outcomes
1
Systolic- and diastolic heart chamber dimensions
Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)
Time frame
Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline2
Systolic- and diastolic longitudinal strain
Cardiac morphology and function will be assessed by echocardiography (2D and 3D echocardiography and 2D strain echocardiography)
Time frame
Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline3
Lean body mass
Body composition will be assessed by dual x-ray absorptiometry
Time frame
Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline4
Fat mass
Body composition will be assessed by dual x-ray absorptiometry
Time frame
Baseline, five months from baseline (i.e. end of intervention) and 2 years from baselineOther outcomes
1
Muscle genome-wide DNA methylation and gene expression
Will be assessed in Norway only. For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA
Time frame
Baseline, five months from baseline (i.e. end of intervention)2
Adverse events
Medical records and Patient reported outcome version of the Common Terminology Criteria for Adverse Events.
Time frame
Five months from baseline (i.e. end of intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian School of Sport Sciences
Lead sponsor
Uppsala University
Collaborator
Source ClinicalTrials.gov