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Trial Title:
Training for Men Undergoing Androgen Deprivation Therapy.
NCT ID:
NCT06449664
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Androgen deprivation therapy (ADT)
Flywheel training
High intensity training (HIT)
Resistance training
Aerobic training
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
ADT-train
Description:
A new training concept is tested on men with prostate cancer receiving androgen
deprivation therapy
Arm group label:
Exercise
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.
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 participant's power output at VO2peak. The total duration of a training
session will be 30-40 min (including worm-up).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. signed informed consent
2. histologically confirmed localised or locally advanced prostate cancer
3. planned radiotherapy in combination with ADT for at least six months (unfavorable
intermediate risk and high-risk prostate cancer) with curative intent and with no
known metastasis.
Exclusion Criteria:
1. very high risk localised prostate cancer planned for radiotherapy and ADT plus
abiraterone and cortisone
2. localized prostate cancer planned for radiotherapy without ADT
3. on-going or previously treated with ADT or other hormonal treatments
4. have any contraindications to physical testing/exercise as per the ACSM guidelines
5. unable to comply with study procedures
Gender:
Male
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Swedish School of Sport and Health Sciences
Address:
City:
Stockholm
Zip:
11486
Country:
Sweden
Status:
Recruiting
Contact:
Last name:
Niklas Psilander, PhD
Phone:
+46 8 120 538 23
Email:
niklas.psilander@gih.se
Investigator:
Last name:
Niklas Psilander, PhD
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
December 20, 2028
Lead sponsor:
Agency:
The Swedish School of Sport and Health Sciences
Agency class:
Other
Collaborator:
Agency:
Norwegian School of Sport Sciences
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Prostate Cancer Foundation
Agency class:
Other
Collaborator:
Agency:
Sahlgrenska University Hospital, Sweden
Agency class:
Other
Source:
The Swedish School of Sport and Health Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06449664
