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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorRoyal Marsden NHS Foundation Trust

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy

New symptoms of angina

New or unstable heart failure

Newly diagnosed diabetes that is not controlled

Trial design

Treatments tested in this trial

  • Participation in a digital exercise intervention with virtual supervised group exercise sessions

Treatment groups

160 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Royal Marsden NHS Foundation Trust

Lead sponsor

King's College London

Collaborator