Training for Men Undergoing Androgen Deprivation Therapy.
NCT ID: NCT06449664
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-05-01
2028-12-20
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise
The participants will exercise twice weekly performing the newly developed training concept including flywheel resistance training followed by aerobic cycling intervals.
ADT-train
A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
Control group
The participants will receive usual care only.
No interventions assigned to this group
Interventions
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ADT-train
A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
80 Years
MALE
No
Sponsors
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Norwegian School of Sport Sciences
OTHER
Karolinska Institutet
OTHER
Prostate Cancer Foundation
OTHER
Sahlgrenska University Hospital
OTHER
The Swedish School of Sport and Health Sciences
OTHER
Responsible Party
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Locations
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Swedish School of Sport and Health Sciences
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-00964-01
Identifier Type: -
Identifier Source: org_study_id
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