The Remote Study: Investigating the Effects or Online Exercise on Quality of Life in Men With Prostate Cancer

Официальное название

An Individualised 8-week Remote Exercise Intervention to Improve QoL, Cardiometabolic Risk and Physical Activity Level in Men With Prostate Cancer Undergoing ADT Treatment.

Обзор

Currently, there are few opportunities for patients with cancer to have individual exercise guidance, and this has further been impacted by the Covid-19 pandemic. However, during the pandemic the use of virtual/remote platforms has been crucial in delivering care to cancer patients. The investigators think that remote exercise training may also offer a solution to support positive change in prostate cancer patients. As a result, the investigators have developed a remote/online exercise programme to explore this further. This study will explore the effectiveness of an 8-week remote exercise and behavioural support intervention, and whether prostate cancer patients feel they benefit from this. The study also aims to see if this sort of exercise programme can be delivered to more prostate cancer patients in the future. This project is open to men with prostate cancer on long term hormone therapy. The intervention will be comprised of one remote supervised session per week, completed 1-1 using an online platform and up to two additional sessions, depending on its suitability for the patient, will be prescribed as unsupervised home-based exercise.

Вмешательства

• Поведенческое Exercise
  8 week exercise intervention, 3x/wk

Первичные конечные точки

• Functional Assessment of Cancer Therapy-Prostate [Срок оценки: t= 0, 4, 8, 16 & 30 weeks]
• Functional Assessment of Cancer Therapy [Срок оценки: t= 0, 4, 8, 16 & 30 weeks]

Вторичные конечные точки (5)

• Leisure time physical activity [Срок оценки: t= 0, 4, 8, 16 & 30 weeks]
• Physical activity [Срок оценки: t= 0, 4, 8, 16 & 30 weeks]
• Cardiovascular risk [Срок оценки: t= 0, 4, 8 weeks]
• Exercise adherence [Срок оценки: weekly for 8 weeks]
• Health status [Срок оценки: t= 0, 4, 8, 16 & 30 weeks]

Критерии участия

Критерии включения

• Have had an orchiectomy OR;
• Are receiving a GnRH agonist/antagonist OR;
• Are currently receiving Abiraterone, Enzalutamide, Apalutamide or Darolutamide
• Long-term retention is planned (intending to remain on the above stated treatments for at least the next 6 months).

Критерии исключения

• Patients who are currently classed as in active treatment i.e. are currently receiving chemotherapy/radiation therapy (Note: Patients that are included in the study but after inclusion are moved onto chemo/radiation therapy, will still be able to participate in the project).
• Patients who are stratified as high risk for having a cardiovascular event.
• Acute illness; or any musculoskeletal, cardiovascular or neurological disorder that could inhibit or put them at risk from exercising, as determined by screening and their clinician.
• Men with painful or unstable bony metastases.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Великобритания · 1 центр

• University of Surrey — Guildford

Идентификаторы

NCT: NCT05989854 · 956732-956714-101614486

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗