Training for Men Undergoing Androgen Deprivation Therapy.

Официальное название

ADT-Train - A New Training Concept for Men With Prostate Cancer Receiving Androgen Deprivation Therapy.

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое ADT-train
  A new training concept is tested on men with prostate cancer receiving androgen deprivation therapy

Первичные конечные точки

• Aerobic fitness [Срок оценки: Baseline and after 6 and 12 weeks]
• Maximal leg strength [Срок оценки: Baseline and after 6 and 12 weeks]

Вторичные конечные точки (12)

• Body fat [Срок оценки: Baseline and after 6 and 12 weeks]
• Lean body mass [Срок оценки: Baseline and after 6 and 12 weeks]
• Bone mineral density [Срок оценки: Baseline and after 6 and 12 weeks]
• Quadriceps cross-sectional area [Срок оценки: Baseline and after 6 and 12 weeks]
• Static balance [Срок оценки: Baseline and after 6 and 12 weeks]
• Walk capacity [Срок оценки: Baseline and after 6 and 12 weeks]
• Lower body muscular endurance [Срок оценки: Baseline and after 6 and 12 weeks]
• Blood pressure [Срок оценки: Baseline and after 6 and 12 weeks]
• Whole body glucose uptake [Срок оценки: Baseline and after 6 and 12 weeks]
• Whole body insulin response [Срок оценки: Baseline and after 6 and 12 weeks]
• Blood biomarkers related to cardiovascular disease. [Срок оценки: Baseline and after 6 and 12 weeks]
• Muscle fiber cross-sectional area (CSA) [Срок оценки: Baseline and after 12 weeks]

Критерии участия

Критерии включения

• signed informed consent
• histologically confirmed localised or locally advanced prostate cancer
• 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.

Критерии исключения

• very high risk localised prostate cancer planned for radiotherapy and ADT plus abiraterone and cortisone
• localized prostate cancer planned for radiotherapy without ADT
• on-going or previously treated with ADT or other hormonal treatments
• have any contraindications to physical testing/exercise as per the ACSM guidelines
• unable to comply with study procedures

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Швеция · 1 центр

• Swedish School of Sport and Health Sciences — Stockholm

Идентификаторы

NCT: NCT06449664 · 2024-00964-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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