Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449664
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-04
Brief Title:
Training for Men Undergoing Androgen Deprivation Therapy
Sponsor:
The Swedish School of Sport and Health Sciences
Organization:
The Swedish School of Sport and Health Sciences
Study Overview
Official Title:
ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
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:
ADT-train
Brief Summary:
The goal of this clinical trial is to evaluate the effects of a newly developed training concept on men with prostate cancer undergoing androgen deprivation therapy ADT
The main questions it aims to answer are
How feasible and safe is the new training concept
How efficient is the training concept to counteract side effects caused by ADT
Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects
Participants in the intervention group will perform the new training concept twice weekly for 12 weeks Participants in the control group will only receive usual care All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes
The main questions it aims to answer are
How feasible and safe is the new training concept
How efficient is the training concept to counteract side effects caused by ADT
Researchers will compare the new training concept with usual care to evaluate how efficient the training concept is to counteract the ADT-related side effects
Participants in the intervention group will perform the new training concept twice weekly for 12 weeks Participants in the control group will only receive usual care All participants will visit the laboratory at baseline and after 6 and 12 weeks to measure the primary and secondary outcomes
Detailed Description:
Detailed description of the training concept applied in the intervention
The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24 20 s intervals on a Monark cycle ergometer The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block When a participant manages to perform all 3 blocks with 8 intervals in each block a total of 24 intervals the resistance will be increased by 20 W The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min The starting workload of the intervals will be individually adjusted to 115 of the participants power output at VO2peak The total duration of a training session will be 30-40 min including worm-up
The two weekly training sessions will be separated by at least two days and supervised by appropriately trained exercise professionals at The Swedish School of Sport and Health Sciences The training includes a 10 min warm-up followed by 3-4 sets of 8 maximal repetitions on the flywheel machine followed by 16-24 20 s intervals on a Monark cycle ergometer The intervals will be performed as 3 blocks with the intention to execute 8 intervals in each block When a participant manages to perform all 3 blocks with 8 intervals in each block a total of 24 intervals the resistance will be increased by 20 W The rest period between the intervals will be set to 10 s and the rest between the blocks to 2 min The starting workload of the intervals will be individually adjusted to 115 of the participants power output at VO2peak The total duration of a training session will be 30-40 min including worm-up
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