Effects of Exercise Training in Survivors of Lymphoma

Official title

The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors

Overview

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.

Detailed description

In this study, a comparison of the exercise effects between individuals previously treated for specific lymphoma diagnoses and individuals with no history of cancer will be conducted. Therefore, in addition to a randomized controlled trial in individuals with a previous lymphoma diagnosis (i.e., exercise groups and a non-exercising control group), a reference group comprising age- and sex-matched individuals with no history of a cancer diagnosis will also be included. Participants in the reference group will undergo the same exercise intervention as the aerobic exercise group. This study recruits through invitation only.

The primary endpoint in this study is the change in cardiorespiratory fitness, assessed as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, other variables derived from the cardiopulmonary exercise test and lung function assessments, and muscle cellular endpoints from muscle biopsies obtained from m. vastus lateralis, in addition to patient-reported outcomes.

Interventions

• Behavioral Aerobic Exercise
  Participants 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 withi
• Behavioral Combined Aerobic and Resistance Exercise
  Twice 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

Primary outcome measures

• VO2peak [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]

Secondary outcome measures (12)

• Systolic- and diastolic heart chamber dimensions [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Systolic- and diastolic longitudinal strain [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Lean body mass [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Fat mass [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Forced Vital Capacity [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Forced Expiratory Volume 1 sec [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Maximal voluntary ventilation [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Diffusion capacity [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Physical activity [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Physical activity [Time frame: Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Global Health related Quality of life [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]
• Blood volume [Time frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline]

Eligibility criteria

Inclusion Criteria Lymphoma participants:

• 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
• No severe cancer-related fatigue (per self-report)

Inclusion Criteria Lymphoma participants and non-cancer reference group:

• Currently not performing >75 minutes/week of aerobic exercise
• Willing and able to adhere to all study procedures.

Exclusion Criteria Lymphoma participants:

• Relapse since diagnosis
• A history, or current presence, of another diagnosis of invasive cancer of any kind

Exclusion Criteria Lymphoma participants and non-cancer reference group:

• Presence of any uncontrolled- or recent cardiovascular disease
• Has undergone heart surgery
• Uses a pacemaker
• Pregnancy
• Unable to read and understand Swedish (applicable for the Swedish site only)
• Unable to read and understand Norwegian (applicable for the Norwegian site)
• Any physical or mental health condition restricting adherence to study protocol

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Norway · 1 center

• Norweigan School of Sport Sciences — Oslo

Sweden · 1 center

• Helena Igelström — Uppsala

Identifiers

NCT: NCT06270667 · LYMfit

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗