RecruitingNot ApplicableNCT07243834

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

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.


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

160 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital (app-based) exercise program for men with prostate cancer who are receiving hormone therapy (called ADT). Hormone therapy causes side effects like fatigue and muscle loss, and this trial tests whether a structured online exercise program can help manage those effects and improve overall health. **You may be eligible if...** - You are a man with confirmed prostate cancer - You are currently receiving or about to start hormone therapy (LHRHa) - If already on hormone therapy, you have been on it for 8 weeks or less - You are over 18 years old **You may NOT be eligible if...** - You have already been on hormone therapy for more than 8 weeks - You have health conditions that prevent safe exercise participation - Your cancer has spread in ways that would make exercise unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERParticipation 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. Participants will also have the option to take part in the patient buddy scheme which includes three support phone calls from a fellow patient at The Royal Marsden NHS Foundation Trust. One phone call will be scheduled at the start of the exercise programme, one halfway through the programme, and one at the end of the programme. Individual review appointments with the CEP will be scheduled at Week 13 and Week 26 to review progress and address any barriers to exercise adherence.


Locations(1)

The Royal Marsden Hospital

London, United Kingdom

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NCT07243834


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