Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT05485428
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2022-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The HIIT-Home4Parkinson's Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessor blinded to group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled feasibility study with mechanistic, physiological and clinical sub components'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2022-07-27', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total weekly habitual physical activity', 'timeFrame': '1 week prior to start of exercise programme after baseline assessments', 'description': 'Weekly physical activity (minutes) measured with accelerometer, self administered'}, {'measure': 'Total weekly habitual physical activity', 'timeFrame': 'During week 7 of the exercise programme', 'description': 'Weekly physical activity (minutes) measured with accelerometer, self administered'}, {'measure': 'Maximum heart rate', 'timeFrame': '1 week before first exercise session', 'description': 'Beats per minute, to be measured during VO2max assessment'}, {'measure': 'Height', 'timeFrame': '1 week before first exercise session', 'description': 'Height (centimetres) with stadiometer'}, {'measure': 'Weight', 'timeFrame': '1 week before first exercise session', 'description': 'Weight (kilograms) with calibrated digital scales'}, {'measure': 'Lifestyle data questionnaire', 'timeFrame': '1 week before first exercise session', 'description': '10-item basic lifestyle data bespoke questionnaire'}, {'measure': 'Health screening questionnaire', 'timeFrame': '1 week before first exercise session at baseline assessments', 'description': 'Screening for health issues that may prevent participation'}], 'primaryOutcomes': [{'measure': 'Programme completion', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Number of weeks of exercise programme completed, self administered'}, {'measure': 'Programme adherence', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Number of exercise sessions completed in full, self administered'}, {'measure': 'Change from baseline brain derived neurotrophic factor (BDNF)', 'timeFrame': '1 week before first exercise session and 1 day after last session.', 'description': 'Blood sample: Brain-derived neurotrophic factor (pg/ml)'}, {'measure': 'Change from baseline Relative VO2max', 'timeFrame': '1 week before first exercise session and 1 day after last session.', 'description': 'Maximal oxygen uptake (ml/min/kg) incremental exercise test'}], 'secondaryOutcomes': [{'measure': 'Adverse effects and events', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Adverse effects and events related to exercise sessions, self administered'}, {'measure': 'Change from baseline 30 second sit to stand test', 'timeFrame': '1 week before first exercise session and 1 day after last session.', 'description': 'Number of times standing in 30 seconds'}, {'measure': 'Oxford Participation Activities Questionnaire', 'timeFrame': '1 week before first exercise session and 1 day after last session', 'description': 'Participant administered lifestyle questionnaire'}, {'measure': "Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3", 'timeFrame': '1 week before first exercise session and 1 day after last session.', 'description': 'Motor examination, minimum score 0, maximum score 76, higher scores indicate increased disease severity'}, {'measure': 'Exercise intensity', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Achieved exercise intensity (% of maximum heart rate), self administered'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIIT', 'Exercise', 'Neurodegenerative', 'Physical', 'High-intensity', 'Interval', 'Home-based', 'Training'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '40661734', 'type': 'DERIVED', 'citation': "Harpham C, Gunn H, Marsden J, Bescos-Garcia R, Murgatroyd C, Connolly L. Home-Based High-Intensity Interval Training for People With Parkinson's: A Randomized, Controlled, Feasibility Trial. Health Sci Rep. 2025 Jul 14;8(7):e71024. doi: 10.1002/hsr2.71024. eCollection 2025 Jul."}]}, 'descriptionModule': {'briefSummary': "This project aims to investigate the practicality and utility of home-based high-intensity interval training (HIIT) by undertaking a previously developed, novel home-based HIIT intervention for people with Parkinson's (PwP).", 'detailedDescription': "This is a randomised controlled feasibility study with mechanistic, physiological and clinical sub components.\n\nParticipants will be undertaking a 12-week home-based high-intensity interval training intervention. The programme is a feasibility study, previously co-created by people with Parkinson's and clinicians within an iterative planning process of focus groups and exercise testing.\n\nFollowing recruitment, participants will undertake initial baseline assessments. These will involve collection of anthropometric measurements and general lifestyle and Parkinson's related information, followed by pre-intervention mechanistic, physiological and clinical outcome measures. Participants will then be randomised to the HIIT intervention, or usual care control group.\n\nBoth groups will then undertake 7 days pre-intervention physical activity monitoring following accelerometer instruction, as a baseline measure of habitual physical activity (an important confounding variable).\n\nFollowing an initial home visit, participants will then undertake a 12-week high-intensity interval training programme in the home setting, with supplied exercise equipment including music and exercise prompts, and remote support and online resources. Participants will complete a 32 minute training session 3 times per week, with at least one day of rest between sessions. Participants will be loaned heart rate monitoring devices, which will remotely record heart rate per exercise session. During week 7 of the intervention, participants will be asked to repeat 7 days of accelerometer wearing to compare habitual physical activity. Participants will record feasibility and safety aspects such as HIIT participation / adverse effects and events / exercise adaptations in diaries during the course of the intervention.\n\nParticipants will then undergo post-intervention outcome measures. Participants will also be asked to be involved in a 45-minute post intervention focus group as part of a process evaluation. Depending on numbers, it is likely that there will be 2 of these parallel groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Diagnosed with Parkinson's disease\n* Aged 18 years or older (No upper limit)\n* Hoehn and Yahr stages 1-3 (Mild to moderate disease severity)\n* Capacity to consent under the Mental Capacity Act 2005, and able to follow an exercise programme\n* Based at home with enough space to perform an exercise programme\n* Willing and able to travel to intervention assessments\n* Access to a computer, Smart Phone, or tablet and to the internet.\n\nExclusion criteria:\n\n* Other concurrent neurological condition\n* Co-morbidities that would prevent / be exacerbated by high-intensity exercise such as forms of cardiovascular disease\n* Advised to not participate following medical consultation\n* Participation in a contemporaneous interventional study"}, 'identificationModule': {'nctId': 'NCT05485428', 'acronym': 'HH4P', 'briefTitle': "The HIIT-Home4Parkinson's Study", 'organization': {'class': 'OTHER', 'fullName': 'University of Plymouth'}, 'officialTitle': "Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study", 'orgStudyIdInfo': {'id': 'UPlymouthCH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise', 'description': 'High-intensity interval training plus usual care', 'interventionNames': ['Other: High-intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care / treatment. Usual physical activity.'}], 'interventions': [{'name': 'High-intensity interval training', 'type': 'OTHER', 'description': '12-weeks of high intensity interval exercise, 30 minutes thrice weekly', 'armGroupLabels': ['Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PL68DH', 'city': 'Plymouth', 'state': 'Devon', 'country': 'United Kingdom', 'facility': 'University Hospitals Plymouth NHS Trust', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'De-identified data will be available for a period of 10 years in line with University of Plymouth policy', 'ipdSharing': 'YES', 'accessCriteria': 'On request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Plymouth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student, Principal Investigator', 'investigatorFullName': '(Ivan) Conrad Harpham', 'investigatorAffiliation': 'University of Plymouth'}}}}