Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07243834

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prostate Cancer Behavior Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Motor Activity Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostate Cancer (Diagnosis) Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location status: Recruiting

Location contact

Sijy Pillai

CONTACT

[email protected]

02078118116

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing
  • Fluent in English and able to understand instructions
  • WHO performance status 0-2
  • Able to give written informed consent

Exclusion criteria

  • Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy
  • 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)
  • Unstable spinal bone metastasis or at high risk of a fracture
  • Musculoskeletal issue inhibiting exercise

Treatment and study plan

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.

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.

Other names: Exercise intervention

Primary outcomes

  1. The primary endpoint is adherence to physical activity and exercise guidelines assessed using device-based activity data and self-reported physical activity and exercise data at six-months post-radiotherapy.

    Time frame: Measured at six months post radiotherapy

    Activity data will be measured using the ActiGraph LEAP wearable activity monitor and an Exercise Diary.

    To calculate physical activity and exercise adherence, we will compare the measured total volume of physical activity compared to the target volume of physical activity.

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Collaborators

  • King's College London

Registry information

Official study title

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.

Acronym: ADHERE

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
Nov 24, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.