Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT07243834

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

Led by Royal Marsden NHS Foundation Trust · Updated on 2026-01-30

160

Participants Needed

1

Research Sites

227 weeks

Total Duration

On this page

Sponsors

R

Royal Marsden NHS Foundation Trust

Lead Sponsor

K

King's College London

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years at randomisation
  • Male with confirmed prostate adenocarcinoma receiving or planned to receive ADT with LHRHa
  • If already started ADT, no more than eight weeks of treatment at randomisation
  • Planned to receive radiotherapy
  • Assessed as safe to exercise and enter the trial by clinical team
  • Able to use technology required including MyMarsden and video conferencing device
  • Fluent in English and able to follow instructions
  • WHO performance status between 0 and 2
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Planned to receive androgen receptor-targeted agent (ARTA) or chemotherapy
  • Absolute contraindications to exercise per ACPICR standards, including new angina symptoms, new or unstable heart failure, uncontrolled or new diabetes, untreated arrhythmias, abnormal heart rates not linked to medication, symptomatic low blood pressure, or uncontrolled high blood pressure (SBP ≥ 180mmHg or DBP ≥ 100mmHg)
  • Unstable spinal bone metastasis or high risk of fracture
  • Musculoskeletal conditions preventing exercise

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Royal Marsden Hospital

London, United Kingdom, SW3 6JJ

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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