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

NCT ID: NCT07243834

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-19
• Study Completion Date: 2030-04-28

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care (SoC)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

SoC + digital exercise intervention with virtual supervised group exercise sessions

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Participation 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.

Intervention Type: OTHER

Other Intervention Names

Exercise intervention

Eligibility Criteria

Inclusion Criteria

1. Age > 18 at randomisation

2. Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment

3. If already started ADT, have received no more than eight weeks ADT at randomisation

4. Planned for radiotherapy

5. 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

6. Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing

7. Fluent in English and able to understand instructions

8. WHO performance status 0-2

9. Able to give written informed consent

Exclusion Criteria

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

2. 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)

3. Unstable spinal bone metastasis or at high risk of a fracture

4. Musculoskeletal issue inhibiting exercise

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CCR6225

Identifier Type: -

Identifier Source: org_study_id