Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT05260567
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2022-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}, {'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2022-02-18', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the program', 'timeFrame': 'post 12 weeks', 'description': 'Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed)'}, {'measure': 'Acceptability of the program', 'timeFrame': 'post 12 weeks', 'description': 'Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups.'}], 'secondaryOutcomes': [{'measure': 'Six-minute walk test (6MWT)', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'Walking Impairment Questionnaire (WIQ)', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'Walking Estimated Limitation Calculated by History (WELCH) questionnaire', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'Vascular quality of life questionnaire (VascuQoL-6)', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'EuroQoL questionnaire (EQ-5D-5L).', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'Short Form Dietary Questionnaire', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'Physical activity levels (Fitbit Charge HR)', 'timeFrame': 'pre and post-12 weeks'}, {'measure': 'Sleep', 'timeFrame': 'pre and post-12 weeks', 'description': '(Fitbit Charge HR)'}, {'measure': 'Alcohol and tobacco use', 'timeFrame': 'pre and post-12 weeks', 'description': 'The 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and self-reported smoking habits'}, {'measure': 'Mental wellbeing', 'timeFrame': 'pre and post-12 weeks', 'description': 'hospital anxiety-depression score (HADS)'}, {'measure': 'Patient activation', 'timeFrame': 'pre and post-12 weeks', 'description': 'The Patient Activation Measure (PAM®)'}, {'measure': 'Resource utilisation', 'timeFrame': 'pre and post-12 weeks', 'description': 'The case report forms (CRF)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Intermittent Claudication', 'Behavior, Health', 'Exercise Intervention']}, 'descriptionModule': {'briefSummary': "Peripheral arterial disease is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the mainstay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals, this isn't undertaken, and with the issues around group-based sessions and repeated visits to hospitals, this treatment option is not available with the coronavirus pandemic.\n\nThis is a single-centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. Also, some patients will be involved in focus groups to understand their experience of the intervention and whether it is feasible and acceptable, allowing changes to be made to the program.\n\nThe primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PAD confirmed by ankle-brachial index \\<0.90 in one or both limbs\n* Age \\>= 40 years\n* Able to walk distance \\>50m\n* Live in an area deemed in lowest 30% of super output area from Office of National Statistics\n\nExclusion Criteria:\n\n* chronic limb threatening ischemia\n* short claudication distance \\<50m\n* severe heart disease (Grade III or IV, New York Heart Association)\n* severe ischemic or haemorrhagic stroke or neurodegenerative diseases\n* severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic\n* blood pressure of more than 100 mm Hg)\n* uncontrolled cardiac arrhythmias (unstable angina during the previous month and\n* myocardial infarction during the previous month)\n* a resting heart rate of more than 120 beats per minute\n* has already undergone angioplasty, bypass or other surgical intervention for PAD\n* other severe comorbid conditions preventing the ability to engage in physical activity,\n* inability or unwillingness to undertake the commitments of the study'}, 'identificationModule': {'nctId': 'NCT05260567', 'briefTitle': 'Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'A Multimodal Tele-health Behavioural Intervention in Patients With Peripheral Arterial Disease From Low Socio-economic Areas: a Feasibility and Pilot Randomized Controlled Trial With Embedded Process Evaluation', 'orgStudyIdInfo': {'id': '286735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and Lifestyle Change', 'description': 'Exercise training and lifestyle change', 'interventionNames': ['Behavioral: Exercise and Lifestyle Change']}, {'type': 'OTHER', 'label': 'Standard Care', 'description': 'Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline.', 'interventionNames': ['Behavioral: Exercise and Lifestyle Change']}], 'interventions': [{'name': 'Exercise and Lifestyle Change', 'type': 'BEHAVIORAL', 'description': "Patients will undergo to weekly phone call/videoconference for 12 weeks and discuss the behaviour change.\n\nThey also will undergo to home-based exercise training will be performed twice a week for 12 weeks via Zoom (up to 5 patients per session). Each session will be comprised of warm-up (10 min), the main part (15 to 20 min), and cooldown (5 to 10 min). The training aims to develop resistance, aerobic and functional capacity such as getting up, walking, pulling, pushing, throwing, transferring body weight or external loads. In addition, patients will be encouraged to increase their physical activity. Patients will be provided with a Fitbit device to monitor their step count and will be recommended to increase their previous week's average step count by 10%.", 'armGroupLabels': ['Exercise and Lifestyle Change', 'Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Freeman Hospital - Newcastle upon Tyne NHS trust', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'James Prentis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Freeman Hospital - Newcastle upon Tyne NHS trust'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice Chancellor Research Fellow', 'investigatorFullName': 'Gabriel Cucato', 'investigatorAffiliation': 'Northumbria University'}}}}