NCT06270667

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable lymphoma

Timeline
28mo left

Started Mar 2024

Typical duration for not_applicable lymphoma

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Mar 2024Sep 2028

First Submitted

Initial submission to the registry

January 19, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

4.5 years

First QC Date

January 19, 2024

Last Update Submit

March 20, 2024

Conditions

LymphomaPhysical ExerciseCardiotoxicityCardiovascular DiseasesChemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

  • VO2peak

    Peak oxygen uptake during a treadmill-based cardiopulmonary exercise test

    Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

Secondary Outcomes (15)

  • Systolic- and diastolic heart chamber dimensions

    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

  • Lean body mass

    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

  • Forced Vital Capacity

    Baseline, five months from baseline (i.e. end of intervention) and 2 years from baseline

  • +10 more secondary outcomes

Other Outcomes (2)

  • Muscle genome-wide DNA methylation and gene expression

    Baseline, five months from baseline (i.e. end of intervention)

  • Adverse events

    Five months from baseline (i.e. end of intervention)

Study Arms (4)

Aerobic Exercise

EXPERIMENTAL

Aerobic Exercise twice weekly for 5 months.

Behavioral: Aerobic Exercise

Combined Aerobic and Resistance Exercise

EXPERIMENTAL

Combined Aerobic and Resistance Exercise twice weekly for 5 months.

Behavioral: Combined Aerobic and Resistance Exercise

Standard Care

NO INTERVENTION

Standard Care, i.e no exercise intervention.

Reference Aerobic Exercise

ACTIVE COMPARATOR

Aerobic Exercise twice weekly for 5 months.

Behavioral: Aerobic Exercise

Interventions

Aerobic ExerciseBEHAVIORAL

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)

Aerobic ExerciseReference Aerobic Exercise
Combined Aerobic and Resistance ExerciseBEHAVIORAL

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.

Combined Aerobic and Resistance Exercise

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norweigan School of Sport Sciences

Oslo, Norway

NOT YET RECRUITING

Helena Igelström

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

LymphomaMotor ActivityCardiotoxicityCardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehaviorHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Tormod S. Nilsen, PhD

    Norwegian School of Sport Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tormod S. Nilsen, PhD

CONTACT

95069857tormodsn@nih.no

Helena Igelström, PhD

CONTACT

729999599helena.igelstrom@neuro.uu.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

January 19, 2024

First Posted

February 21, 2024

Study Start

March 20, 2024

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)SE(1)