NCT07243834 Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise
| NCT ID | NCT07243834 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Marsden NHS Foundation Trust |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2025-12-16 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 at randomisation 2. Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment 3. If already started ADT, have received no more than eight weeks ADT at randomisation 4. Planned for radiotherapy 5. 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 6. Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing 7. Fluent in English and able to understand instructions 8. WHO performance status 0-2 9. Able to give written informed consent Exclusion Criteria: 1. Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy 2. 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) 3. Unstable spinal bone metastasis or at high risk of a fracture 4. Musculoskeletal issue inhibiting exercise
Frequently Asked Questions
Who can join the NCT07243834 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07243834 currently recruiting?
Yes, NCT07243834 is actively recruiting participants. Visit ClinicalTrials.gov or contact Royal Marsden NHS Foundation Trust to inquire about joining.
Where is the NCT07243834 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07243834 clinical trial?
NCT07243834 is sponsored by Royal Marsden NHS Foundation Trust. The trial plans to enroll 160 participants.
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