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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care (SoC)
Participants will be sent a link to a webpage which provides information on physical activity and exercise guidelines, local and nationally available exercise, and contact details for the RMH physiotherapy department with the option to self-refer for further support.
SoC + digital exercise intervention with virtual supervised group exercise sessions
Participants will receive standard of care and a digital exercise intervention.
干预措施: Participation in a digital exercise intervention with virtual supervised group exercise sessions (Other)
结局指标
主要结局
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.
时间窗: Measured at six months post radiotherapy
Activity data will be measured using the ActiGraph LEAP wearable activity monitor and an Exercise Diary. To calculate physical activity and exercise adherence, we will compare the measured total volume of physical activity compared to the target volume of physical activity.
次要结局
未报告次要终点