Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299722
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-14
Brief Title:
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
Strength Training Exercises to Minimise Late Effects of Childhood Leukaemia or Lymphoma Among Adolescents - The STEEL Study - a National Multicenter Randomised Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEEL
Brief 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 childadolescent 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None