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Trial Title:
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents
NCT ID:
NCT06299722
Condition:
Cancer
Conditions: Official terms:
Lymphoma
Leukemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
STEEL
Description:
Relatively heavy strength training
Arm group label:
STEEL
Intervention type:
Other
Intervention name:
Circuit training
Description:
Circuit training
Arm group label:
Circuit training
Summary:
We aim to include 60 children and adolescents aged 10 to 19 years who have undergone
successful treatment for leukemia or lymphoma. Based on randomization, they will either
1) commence 16 weeks of training with STEEL or 2) commence 16 weeks of circuit training.
STEEL training involves exercises for major muscle groups using free weights, body
weight, or tailored machines. Circuit training is structured similarly to previous
training for the target group and includes exercises using body weight, exercise balls,
and rings. The training takes place in local centers either with friends or with other
participants in the project. Before starting participation in the project, the
child/adolescent and their parents or guardians will receive information about late
effects, diet, sleep, and exercise, providing guidance and support regarding the project
elements. The effects of the two training modalities will be evaluated based on
self-reported quality of life, muscle strength, muscle mass, bone mineral content,
fitness, and markers of metabolic syndrome (BMI, waist circumference, blood pressure, and
blood analysis).
Detailed description:
The trial is designed as a national randomised clinical trial. Participants will be
stratified by sex and block randomised (block sizes of 2 to 6) at 1:1 to either STEEL or
the circuit training programme. A researcher not involved in the trial will generate the
allocation sequence using a random number generator and is the only person who will know
the block sizes. The study will be conducted at Aalborg University Hospital,
Rigshospitalet, Odense University Hospital, and Aarhus University Hospital and was
designed in collaboration with parents of childhood cancer survivors and an adult
childhood cancer survivor suffering from late effects. Participants must attend three
examinations at their respective hospitals: baseline and after 8 and 16 weeks.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Ten to 19 years of age at the point of inclusion
- A minimum of 12 months since the last chemotherapy with no upper limit
- Ability to understand the physical intervention and general participant advice
Exclusion Criteria:
- Participation in another research study that includes similar treatment
- Pregnancy
- Cardiac arrhythmia during exercise
- Psychological disorders interfering with treatment
- Presence of a clinical condition that needs immediate treatment
- Planned surgeries within the subsequent 12 months that may interfere with performing
exercises
- Any contraindications to performing physical exercise as evaluated by the recruiting
medical doctor
Gender:
All
Minimum age:
10 Years
Maximum age:
19 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Martin K Fridh
Email:
martin.kaj.fridh@regionh.dk
Facility:
Name:
Aalborg University
Address:
City:
Gistrup
Zip:
9260
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Henrik Riel
Email:
hriel@dcm.aau.dk
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Mathias Rathe
Email:
mathias.rathe@rsyd.dk
Facility:
Name:
Århus University Hospital
Address:
City:
Århus
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Clara Vad
Email:
claravad@live.dk
Start date:
April 26, 2024
Completion date:
July 2025
Lead sponsor:
Agency:
Aalborg University
Agency class:
Other
Source:
Aalborg University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06299722
