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

NCT07243834 | Recruiting DMC

• 1 other identifier: CCR6225
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Prostate Cancer (Diagnosis)

Keywords

Exercise intervention; physical activity; adherence

Outcome Measures

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.

  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.

  Measured at six months post radiotherapy

Study Arms (2)

Standard of Care (SoC)

NO INTERVENTION

Participants will be sent a link to a webpage which provides information on physical activity and exercise guidelines, local and nationally available exercise, and contact details for the RMH physiotherapy department with the option to self-refer for further support.

SoC + digital exercise intervention with virtual supervised group exercise sessions

EXPERIMENTAL

Participants will receive standard of care and a digital exercise intervention.

Other: Participation in a digital exercise intervention with virtual supervised group exercise sessions

Interventions

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.

Also known as: Exercise intervention

SoC + digital exercise intervention with virtual supervised group exercise sessions

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• King's College London: collaborator

Study Sites (1)

The Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease; Motor Activity

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): April 28, 2030
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

GB (1)