Effects of Exercise Training in Survivors of Lymphoma

Trial Title: Effects of Exercise Training in Survivors of Lymphoma

NCT ID: NCT06270667

Condition: Lymphoma
Physical Exercise
Cardiotoxicity
Cardiovascular Diseases
Chemotherapeutic Toxicity

Conditions: Official terms:
Lymphoma
Cardiovascular Diseases
Cardiotoxicity

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Aerobic Exercise
Description: 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 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)
Arm group label: Aerobic Exercise
Arm group label: Reference Aerobic Exercise

Intervention type: Behavioral
Intervention name: Combined Aerobic and Resistance Exercise
Description: 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. 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.
Arm group label: Combined Aerobic and Resistance Exercise

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.

Criteria for 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

Gender: All

Minimum age: 20 Years

Maximum age: 70 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Norweigan School of Sport Sciences

Address:
City: Oslo
Country: Norway

Status: Not yet recruiting

Contact:
Last name: Tormod S. Nilsen, PhD

Facility:
Name: Helena Igelström

Address:
City: Uppsala
Country: Sweden

Status: Recruiting

Contact:
Last name: Helena Igelström, PhD

Contact backup:
Last name: Anna Henriksson, PhD

Phone: 709394175

Phone ext: 0046
Email: anna.km.henriksson@uu.se

Investigator:
Last name: Helena Igelström, PhD
Email: Principal Investigator

Investigator:
Last name: Anna Henriksson, PhD
Email: Sub-Investigator

Start date: March 20, 2024

Completion date: September 1, 2028

Lead sponsor:
Agency: Norwegian School of Sport Sciences
Agency class: Other

Collaborator:
Agency: Uppsala University
Agency class: Other

Source: Norwegian School of Sport Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06270667