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

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT07243834

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Participation in a digital exercise intervention with virtual supervised group exercise sessions (other)
How long the study runs
Study runs about 52 months (dates as stated)
About the drug or intervention
Participation in a digital exercise intervention with virtual supervised group exercise sessions — other: 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the Royal Marsden NHS Foundation Trust, is testing a digital exercise programme for men with prostate cancer. It looks at whether the programme improves health outcomes and helps people keep exercising regularly.

Who can take part

  • Men over 18 with confirmed prostate cancer
  • Receiving or planning to receive hormone therapy (ADT) with an LHRH agonist as part of prostate cancer treatment, and no more than eight weeks of it if already started
  • Planning to have radiotherapy
  • Judged safe to exercise by the clinical team
  • Able to use the technology, including the MyMarsden platform and a device for video calls
  • Fluent in English and able to follow instructions
  • Able to give written informed consent
  • WHO performance status 0-2 (broadly, able to carry out daily activities with little or some difficulty)

Who may not be able to

  • Men planning to take an androgen receptor-targeted agent (a type of hormone drug) or chemotherapy
  • Any absolute reason not to exercise, such as new chest pain (angina), new or unstable heart failure, newly diagnosed uncontrolled diabetes, new or untreated irregular heartbeats, a resting heartbeat that is too fast or too slow, fainting or dizziness from low blood pressure, or uncontrolled high blood pressure
  • Unstable cancer spread to the spine or high risk of a bone fracture
  • A muscle or joint problem that stops them exercising

What taking part involves

  • • A digital exercise intervention delivered through technology
  • • Access to the MyMarsden platform and video conferencing sessions

Time commitment: Not stated — ask the trial team about how many visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
Male
Number of participants
160
Started
2025-12-16
Last checked
2026-01

Plain English Summary

What is this study?

  • • Testing a new treatment for prostate cancer
  • • NA - 160 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with prostate cancer
  • • Male only

Where?

  • • London - The Royal Marsden Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Prostate CancerProstate Cancer (Diagnosis)

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: Male only

What the study is looking for

  • ✓Age \> 18 at randomisation
  • ✓Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an...
  • ✓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...

Who cannot take part

  • ✗Men planned to receive an androgen receptor-targeted agent (ARTA) or drug treatment
  • ✗Absolute safety concern 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
See the full 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

Where Is This Study? (1 UK site)

The Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2026-01