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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Participation in a digital exercise intervention with virtual supervised group exercise sessions
Other interventionThe 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Standard of Care (SoC)No intervention 0 interventions
Group B: SoC + digital exercise intervention with virtual supervised group exercise sessionsExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Measured at six months post radiotherapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Royal Marsden NHS Foundation Trust
Lead sponsor
King's College London
Collaborator
Source ClinicalTrials.gov