Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-21 @ 6:50 AM
Study NCT ID:
NCT03141866
Status:
UNKNOWN
Last Update Posted:
2019-07-26
First Post:
2017-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Seated Physical Activity in Ageing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-08-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2017-04-21', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': 'Post-Intervention (2 weeks)', 'description': 'The primary dependent variable of this feasibility study will relate to the eight primary areas of focus of feasibility studies (Bowen et al. 2009), relating to:\n\n* Acceptability\n* Demand\n* Implementation\n* Practicality\n* Adaptation\n* Integration\n* Expansion and\n* Limited-efficacy testing\n\nThese eight aforementioned areas (constituting the one variable of feasibility) will serve as the primary dependent variable for this study, in order to establish the feasibility of a proposed future clinical trial within this setting. The dependent variable of feasibility will be assessed through semi-structured interviews with participants post intervention, while focus groups will be utilised with both the intervention implementers and study support staff in order to assess the primary dependent variable of the study. Participant uptake and adherence records will also be employed throughout.'}], 'secondaryOutcomes': [{'measure': 'Cortisol (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Dehydroepiandrosterone-sulphate (DHEAS) (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Serum cortisol : DHEAS ratio (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'C-reactive proteins (CRP) (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Inflammatory Cytokine: Interleukin 6 (IL-6) (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Inflammatory Cytokine: Tumor Necrosis Factor alpha (TNFα) (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Inflammatory Cytokine: Interferon gamma (IFNy) (Physiological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Hand grip strength (Functional Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Leg strength (Functional Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Leg power output (Functional Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Short Physical Performance Battery (SPPB) (Functional Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Katz Index of Independence in Activities of Daily Living (Katz ADL) (Functional Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Fried Frailty Phenotype (Functional Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Geriatric Depression Scale (GDS) (Psychological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Hospital Anxiety Depression Scale (HADS) (Psychological Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Standardized Mini-Mental State Examination (SMMSE) (Cognitive Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}, {'measure': 'Interpersonal Support Evaluation List (ISEL) (Social Dependent Variable)', 'timeFrame': 'Pre-intervention (baseline), and post-intervention (2 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frail Elderly Syndrome', 'Frailty', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '19362699', 'type': 'BACKGROUND', 'citation': 'Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.'}, {'pmid': '31753876', 'type': 'DERIVED', 'citation': 'Doody P, Lord JM, Greig CA, Whittaker AC. Assessing the feasibility and impact of specially adapted exercise interventions, aimed at improving the multi-dimensional health and functional capacity of frail geriatric hospital inpatients: protocol for a feasibility study. BMJ Open. 2019 Nov 21;9(11):e031159. doi: 10.1136/bmjopen-2019-031159.'}], 'seeAlsoLinks': [{'url': 'http://www.birmingham.ac.uk/generic/panini/index.aspx', 'label': 'Physical Activity and Nutritional INfluences In ageing (PANINI) project website'}, {'url': 'https://twitter.com/PANINI_EU', 'label': 'Physical Activity and Nutritional INfluences In ageing (PANINI) project twitter'}]}, 'descriptionModule': {'briefSummary': 'This trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. This proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity interventions, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a clinical hospital ward setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. This feasibility study is single-centre (taking place in the Harborne Ward of the Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Edgbaston, Birmingham, United Kingdom).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Temporary residents within the Harborne 'living lab' ward of the Queen Elizabeth Hospital Birmingham, Edgbaston, Birmingham, United Kingdom\n* ≥ 65 years of age\n* Frail according to the Fried Frailty criteria: meeting at least three of the five characteristics of frailty (Fried et al. 2001)\n* Have the capacity to speak and read in English\n* Anticipated by their care team to remain on the ward for approximately 14 days post enrolment into the study. This will be advised by the patient's care team.\n\nExclusion Criteria:\n\n* Currently taking part in any other clinical trial which could potentially have an impact upon or influences the findings of the current study\n* Currently terminally ill with life expectancy which is less than the duration of the study's interventions\n* Severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made."}, 'identificationModule': {'nctId': 'NCT03141866', 'acronym': 'SPAA', 'briefTitle': 'Seated Physical Activity in Ageing', 'organization': {'class': 'OTHER', 'fullName': 'University of Birmingham'}, 'officialTitle': '"Determining the Feasibility of Chair-based Physical Activity Interventions, Aimed at Improving Various Aspects of Health and Wellbeing in Geriatric Populations With Pre-existing Frailty, Within a Hospital Ward Setting"', 'orgStudyIdInfo': {'id': 'ERN_16-0986S'}, 'secondaryIdInfos': [{'id': '675003', 'type': 'OTHER_GRANT', 'domain': 'European Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Intervention 1: Move It Or Lose It (MIOLI)', 'description': 'An established chair-based physical activity programme for older adults.', 'interventionNames': ['Other: Exercise Intervention 1: Move It Or Lose It (MIOLI)']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise Intervention 2: Machine-based resistance training', 'description': 'Specialised, chair-based resistance training equipment for older adults.', 'interventionNames': ['Other: Exercise Intervention 2: Machine-based resistance training intervention']}], 'interventions': [{'name': 'Exercise Intervention 1: Move It Or Lose It (MIOLI)', 'type': 'OTHER', 'description': 'An established chair-based physical activity programme for older adults.', 'armGroupLabels': ['Exercise Intervention 1: Move It Or Lose It (MIOLI)']}, {'name': 'Exercise Intervention 2: Machine-based resistance training intervention', 'type': 'OTHER', 'description': 'Specialised, chair-based, pneumatic resistance training equipment for older adults.', 'armGroupLabels': ['Exercise Intervention 2: Machine-based resistance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B15 2TH', 'city': 'Birmingham', 'state': 'West Midlands', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dr. Zoe Wyrko', 'role': 'CONTACT', 'email': 'zoe.wyrko@uhb.nhs.uk'}, {'name': 'Dr. Thomas Jackson', 'role': 'CONTACT', 'email': 't.jackson@bham.ac.uk'}], 'facility': 'Harborne Ward, Queen Elizabeth Hospital Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'centralContacts': [{'name': 'Mr. Paul Doody', 'role': 'CONTACT', 'email': 'p.d.doody@bham.ac.uk', 'phone': '+44 (0) 121 414', 'phoneExt': '4125'}, {'name': 'Prof. Anna Whittaker', 'role': 'CONTACT', 'email': 'a.c.whittaker@bham.ac.uk', 'phone': '+44 (0) 121 414', 'phoneExt': '4398'}], 'overallOfficials': [{'name': 'Prof. Anna Whittaker', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Queen Elizabeth Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}