Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise

Официальное название

Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise (ADHERE): A Randomised Controlled Trial Comparing the Efficacy of a Digital Exercise Intervention With Virtual Supervised Group Exercise Sessions to Standard of Care on Exercise Adherence at Six Months in Patients With Prostate Cancer Undergoing Hormone Therapy.

Обзор

Patients diagnosed with prostate cancer and receiving hormone therapy in conjunction with radiotherapy are likely to suffer from adverse effects caused by ADT treatment either short term or long term. The most common side effects include changes in body composition leading to increased visceral fat and reduced lean muscle mass, increased risk of cardiovascular events and fatigue, which overall lower quality of life. There is strong evidence to support exercise interventions in minimising, and in some cases reversing many ADT -related toxicities, but exercise adherence remains a challenge for people living with prostate cancer, particularly due to logistical barriers to attendance such as cost and travel time, as well as insufficient motivation. The aim of this single centre, phase III randomised controlled trial is to assess the efficacy of a new digital exercise programme with virtual supervised group exercise sessions in improving adherence to exercise guidelines. The trial aims to recruit 160 participants with prostate cancer undergoing ADT, who will be allocated either the standard of care group or standard of care plus participation in the digital exercise intervention on a 1:1 ratio. Adherence to physical activity will be measured using a wearable accelerometer, an exercise diary, self-reported questionnaires and clinic based assessments at 3 months, 6 months and 12 months post radiotherapy treatment. Recruitment will take place at the Royal Marsden NHS Foundation Trust, Chelsea.

Вмешательства

• Другое Participation in a digital exercise intervention with virtual supervised group exercise sessions
  The intervention will involve an initial individual review with a clinical exercise physiologist (CEP) to complete a screening questionnaire, set goals and discuss details of physical activity and the exercise plan. Participants will then attend weekly virtual supervised group exercise sessions and have access to pre-recorded exercise videos as well. Participants will receive motivational emails after each group session and have check-in phone calls with the CEP at week 4 and week 8. Participa

Первичные конечные точки

• The primary endpoint is adherence to physical activity and exercise guidelines assessed using device-based activity data and self-reported physical activity and exercise data at six-months post-radiotherapy. [Срок оценки: Measured at six months post radiotherapy]

Критерии участия

Критерии включения

• Age > 18 at randomisation
• Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment
• If already started ADT, have received no more than eight weeks ADT at randomisation
• Planned for radiotherapy
• Assessed by clinical team to be safe to exercise and safe to enter the trial with no absolute contraindications to exercise as defined by clinical guidance
• Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing
• Fluent in English and able to understand instructions
• WHO performance status 0-2
• Able to give written informed consent

Критерии исключения

• Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy
• Absolute contraindication to exercise as defined by ACPICR standards. This includes:

• New symptoms of angina
• New or unstable heart failure
• Newly diagnosed diabetes that is not controlled
• New or untreated arrhythmias
• Resting tachycardia or new bradycardia (not linked to changes in medications)
• Symptomatic hypotension
• Uncontrolled hypertension (SBP ≥ 180mmHg or DBP≥ 100mmHg)
• Unstable spinal bone metastasis or at high risk of a fracture
• Musculoskeletal issue inhibiting exercise

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

Великобритания · 1 центр

• The Royal Marsden Hospital — London

Идентификаторы

NCT: NCT07243834 · CCR6225

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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