Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-26 @ 1:17 AM
Study NCT ID:
NCT07243834
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Measured at six months post radiotherapy', 'description': 'Activity data will be measured using the ActiGraph LEAP wearable activity monitor and an Exercise Diary.\n\nTo calculate physical activity and exercise adherence, we will compare the measured total volume of physical activity compared to the target volume of physical activity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise intervention', 'physical activity', 'adherence'], 'conditions': ['Prostate Cancer', 'Prostate Cancer (Diagnosis)']}, 'descriptionModule': {'briefSummary': '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.\n\nThere 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.\n\nThe 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.\n\nThe 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.\n\nAdherence 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 at randomisation\n2. Men with histological confirmation of prostate adenocarcinoma who are receiving or planned to receive ADT with an LHRHa as part of their PCa treatment\n3. If already started ADT, have received no more than eight weeks ADT at randomisation\n4. Planned for radiotherapy\n5. 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\n6. Able to use technological aspects of the intervention including access to MyMarsden and a device for video conferencing\n7. Fluent in English and able to understand instructions\n8. WHO performance status 0-2\n9. Able to give written informed consent\n\nExclusion Criteria:\n\n1. Men planned to receive an androgen receptor-targeted agent (ARTA) or chemotherapy\n2. Absolute contraindication to exercise as defined by ACPICR standards. This includes:\n\n * New symptoms of angina\n * New or unstable heart failure\n * Newly diagnosed diabetes that is not controlled\n * New or untreated arrhythmias\n * Resting tachycardia or new bradycardia (not linked to changes in medications)\n * Symptomatic hypotension\n * Uncontrolled hypertension (SBP ≥ 180mmHg or DBP≥ 100mmHg)\n3. Unstable spinal bone metastasis or at high risk of a fracture\n4. Musculoskeletal issue inhibiting exercise'}, 'identificationModule': {'nctId': 'NCT07243834', 'acronym': 'ADHERE', 'briefTitle': 'Assessing a Digital Exercise Intervention for Health Outcomes and Engagement in Regular Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Royal Marsden NHS Foundation Trust'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'CCR6225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care (SoC)', '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.'}, {'type': 'EXPERIMENTAL', 'label': 'SoC + digital exercise intervention with virtual supervised group exercise sessions', 'description': 'Participants will receive standard of care and a digital exercise intervention.', 'interventionNames': ['Other: Participation in a digital exercise intervention with virtual supervised group exercise sessions']}], 'interventions': [{'name': 'Participation in a digital exercise intervention with virtual supervised group exercise sessions', 'type': 'OTHER', 'otherNames': ['Exercise intervention'], 'description': '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.\n\nParticipants 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.\n\nParticipants 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.\n\nIndividual review appointments with the CEP will be scheduled at Week 13 and Week 26 to review progress and address any barriers to exercise adherence.', 'armGroupLabels': ['SoC + digital exercise intervention with virtual supervised group exercise sessions']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': "King's College London", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}