The LYMfit Study: Exercise Training to Prevent Cardiovascular Disease in Lymphoma Survivors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 280
- Locations
- 2
- Primary Endpoint
- VO2peak
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Aerobic Exercise
Aerobic Exercise twice weekly for 5 months.
Intervention: Aerobic Exercise (Behavioral)
Combined Aerobic and Resistance Exercise
Combined Aerobic and Resistance Exercise twice weekly for 5 months.
Intervention: Combined Aerobic and Resistance Exercise (Behavioral)
Standard Care
Standard Care, i.e no exercise intervention.
Reference Aerobic Exercise
Aerobic Exercise twice weekly for 5 months.
Intervention: Aerobic Exercise (Behavioral)
Outcomes
Primary Outcomes
VO2peak
Time Frame: Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline
Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test
Secondary Outcomes
- Systolic- and diastolic heart chamber dimensions(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Lean body mass(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Systolic- and diastolic longitudinal strain(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Maximal voluntary ventilation(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Muscle fiber area(Baseline, five months from baseline (i.e. end of intervention))
- Forced Vital Capacity(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Muscle fiber type(Baseline, five months from baseline (i.e. end of intervention))
- Forced Expiratory Volume 1 sec(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Blood volume(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Fat mass(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Diffusion capacity(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Global Health related Quality of life(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Physical activity(Baseline, 10-12 weeks from baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
- Muscle mitochondria mass(Baseline, five months from baseline (i.e. end of intervention))
- Physical activity(Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline)
Investigators
Tormod Skogstad Nilsen
Principal Investigator, PhD
Norwegian School of Sport Sciences