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

Royal Marsden NHS Foundation Trust

Status: Enrolling

Conditions: Prostate Cancer (Diagnosis); Prostate Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07243834

CCR6225

Details and patient eligibility

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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Standard of Care (SoC)

No Intervention group

Description:

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 group

Description:

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

Treatment:

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