Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-29 @ 2:21 AM
Study NCT ID:
NCT05661058
Status:
UNKNOWN
Last Update Posted:
2023-04-04
First Post:
2022-12-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mapping Sedentary Behaviour in Older Adults Who Are Frail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-01', 'studyFirstSubmitDate': '2022-12-06', 'studyFirstSubmitQcDate': '2022-12-18', 'lastUpdatePostDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility process and resources', 'timeFrame': 'Two months', 'description': 'The purpose of this study was to assess the feasibility of measuring the context of sedentary behaviour among older adults who are frail. We defined feasibility using recruitment, retention, and refusal rates (process feasibility) and the feasibility resource (i.e., can the tools capture context and are participants willing to use the tools). Our criteria for success for process feasibility were to recruit 20 participants within two-months with 85% retention by end of study, and a 20% refusal rate.'}], 'secondaryOutcomes': [{'measure': 'Focus group (Winter)', 'timeFrame': '1 day', 'description': 'The investigators will hold focus groups in groups of 5 participants or less after the winter collection periods to mitigate recall bias. The investigators will use semi-structured interviews to guide the focus group. Transcripts will be transcribed verbatim and analyzed in NVivo using codebook reliability thematic analysis'}, {'measure': 'Regression analysis (Winter)', 'timeFrame': '7 consecutive days', 'description': 'The investigators will conduct an exploratory analysis of secondary outcomes using multiple linear regression in SPSS Statistics version 27 (IBM Corp, Armonk, New York, USA). The independent variable will be the most common sequences of sedentary behaviour during the Winter period, and the dependent variable will be the secondary health outcomes (e.g., frailty level, cognitive status). The covariates will include variables from PROGRESS (i.e., age and sex).'}, {'measure': 'Focus group (Spring)', 'timeFrame': '1 day', 'description': 'The investigators will hold focus groups in groups of 5 participants or less after the spring collection periods to mitigate recall bias. The investigators will use semi-structured interviews to guide the focus group. Transcripts will be transcribed verbatim and analyzed in NVivo using codebook reliability thematic analysis'}, {'measure': 'Regression analysis (Spring)', 'timeFrame': '3 consecutive days (2 weekdays and 1 weekend)', 'description': 'The investigators will conduct an exploratory analysis of secondary outcomes using multiple linear regression in SPSS Statistics version 27 (IBM Corp, Armonk, New York, USA). The independent variable will be the most common sequences of sedentary behaviour during the Spring period, and the dependent variable will be the secondary health outcomes (e.g., frailty level, cognitive status). The covariates will include variables from PROGRESS (i.e., age and sex).'}, {'measure': 'Context of sedentary behaviour (Winter)', 'timeFrame': 'Weekday #1', 'description': "Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals."}, {'measure': 'Context of sedentary behaviour (Winter)', 'timeFrame': 'Weekday #2', 'description': "Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals."}, {'measure': 'Context of sedentary behaviour (Winter)', 'timeFrame': 'Weekend #1', 'description': "Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals."}, {'measure': 'Context of sedentary behaviour (Spring)', 'timeFrame': 'Weekday #1', 'description': "Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals."}, {'measure': 'Context of sedentary behaviour (Spring)', 'timeFrame': 'Weekday #2', 'description': "Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals."}, {'measure': 'Context of sedentary behaviour (Spring)', 'timeFrame': 'Weekend #1', 'description': "Data analyses from the activPAL4TM and indoor positioning system and participants' diaries will be mapped to the Sedentary behaviour International Taxonomy (SIT) using classification scheme content analysis. SIT is a framework developed to help researchers understand the context and determinants of sedentary behaviours. The investigators will post process the data from the indoor positioning system in 15-minute intervals."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedentary behaviour', 'Frailty', 'Falls', 'Old adults'], 'conditions': ['Frailty']}, 'referencesModule': {'references': [{'pmid': '16776798', 'type': 'RESULT', 'citation': 'Walston J, Hadley EC, Ferrucci L, Guralnik JM, Newman AB, Studenski SA, Ershler WB, Harris T, Fried LP. Research agenda for frailty in older adults: toward a better understanding of physiology and etiology: summary from the American Geriatrics Society/National Institute on Aging Research Conference on Frailty in Older Adults. J Am Geriatr Soc. 2006 Jun;54(6):991-1001. doi: 10.1111/j.1532-5415.2006.00745.x.'}, {'pmid': '18261696', 'type': 'RESULT', 'citation': 'Abellan van Kan G, Rolland YM, Morley JE, Vellas B. Frailty: toward a clinical definition. J Am Med Dir Assoc. 2008 Feb;9(2):71-2. doi: 10.1016/j.jamda.2007.11.005. No abstract available.'}, {'pmid': '28936141', 'type': 'RESULT', 'citation': 'Bunt S, Steverink N, Olthof J, van der Schans CP, Hobbelen JSM. Social frailty in older adults: a scoping review. Eur J Ageing. 2017 Jan 31;14(3):323-334. doi: 10.1007/s10433-017-0414-7. eCollection 2017 Sep.'}, {'pmid': '29309502', 'type': 'RESULT', 'citation': 'Gale CR, Westbury L, Cooper C. Social isolation and loneliness as risk factors for the progression of frailty: the English Longitudinal Study of Ageing. Age Ageing. 2018 May 1;47(3):392-397. doi: 10.1093/ageing/afx188.'}, {'pmid': '32058808', 'type': 'RESULT', 'citation': 'Petrusevski C, Choo S, Wilson M, MacDermid J, Richardson J. Interventions to address sedentary behaviour for older adults: a scoping review. Disabil Rehabil. 2021 Oct;43(21):3090-3101. doi: 10.1080/09638288.2020.1725156. Epub 2020 Feb 14.'}, {'pmid': '34169503', 'type': 'RESULT', 'citation': 'Chastin S, Gardiner PA, Harvey JA, Leask CF, Jerez-Roig J, Rosenberg D, Ashe MC, Helbostad JL, Skelton DA. Interventions for reducing sedentary behaviour in community-dwelling older adults. Cochrane Database Syst Rev. 2021 Jun 25;6(6):CD012784. doi: 10.1002/14651858.CD012784.pub2.'}, {'pmid': '20577058', 'type': 'RESULT', 'citation': 'Owen N, Healy GN, Matthews CE, Dunstan DW. Too much sitting: the population health science of sedentary behavior. Exerc Sport Sci Rev. 2010 Jul;38(3):105-13. doi: 10.1097/JES.0b013e3181e373a2.'}, {'pmid': '25542406', 'type': 'RESULT', 'citation': 'Blodgett J, Theou O, Kirkland S, Andreou P, Rockwood K. The association between sedentary behaviour, moderate-vigorous physical activity and frailty in NHANES cohorts. Maturitas. 2015 Feb;80(2):187-91. doi: 10.1016/j.maturitas.2014.11.010. Epub 2014 Nov 25.'}, {'pmid': '19346988', 'type': 'RESULT', 'citation': 'Katzmarzyk PT, Church TS, Craig CL, Bouchard C. Sitting time and mortality from all causes, cardiovascular disease, and cancer. Med Sci Sports Exerc. 2009 May;41(5):998-1005. doi: 10.1249/MSS.0b013e3181930355.'}, {'pmid': '39609010', 'type': 'DERIVED', 'citation': 'Rodrigues IB, Kalra M, Zheng R, Rabinovich A, Ioannidis G, Kobsar D, Bray SR, Adachi JD, Fang Q, Papaioannou A. Mapping context of sedentary behaviour in older adults who are prefrail and frail: an analysis of secondary outcomes from a longitudinal study (MAPS-B). BMJ Open. 2024 Nov 27;14(11):e084610. doi: 10.1136/bmjopen-2024-084610.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to map the context of sedentary behaviour among older adults who are frail. This study uses a unique combination of objective and self-report measures to assess context. The investigators will also hold focus groups to understand which behaviours can be modified and conduct an analysis to understand which types of behaviours are associated with negative health outcomes.', 'detailedDescription': 'Older adults who are frail are potentially the population that might benefit the most from a reduction in sedentary time as they are the most sedentary group and have the highest chronic disease burden. However, there is a dearth of evidence on effective interventions to reduce sedentary behaviour or total sedentary time in older adults, especially among individuals that are frail. Previous studies focused on reducing total sedentary time, while other studies aimed to increase physical activity levels with the assumption that sedentary time will be reallocated to physical activity. But, to date, such interventions have not been effective at reducing total sedentary behaviour time in older adults. Previous studies to reduce sedentary time and behaviour in older adults may not be effective because there is no research on the context of sedentary behaviour, about when and where to intervene, and which specific sedentary behaviours should be targeted. Almost all studies in older adults have assessed total sedentary time, which does not provide enough information to understand the context of sedentary behaviours. The main reason to understand context is because not all sedentary behaviours should be modified as some cognitively engaging sedentary behaviours (e.g., reading, socializing) appear to benefit health, while time spent in more passive activities may be detrimental. Therefore, the goal should not be to reduce total sedentary time, but rather identify sedentary behaviours that may be detrimental to the health of older adults who are frail.\n\nBefore we can develop an intervention to reduce sedentary behaviour among older adults, we must first assess the context of sedentary behaviour. Context is defined as the purpose of the sedentary behaviours, the location where the behaviours occur, the posture of the behaviours (e.g., lying, sitting), social context (e.g., alone or with others), and time of day the behaviours occur. The purpose of this study was to assess the feasibility of measuring the context of sedentary behaviour among older adults who are frail. We defined feasibility using recruitment, retention, and refusal rates (process) and the feasibility resource (i.e., can the tools capture context and are participants willing to use the tools). Our criteria for success were to recruit 20 participants within two months, 85% retention, and 20% refusal. Our secondary objectives are: 1) to determine the context of using objective and subjective measures to assess sedentary behaviours among older adults who are frail; 2) to identify which types of sedentary behaviours can be modified and when and where to intervene; and 3) to conduct an exploratory analysis to determine the association of certain types of sedentary behaviours on health-related outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '60 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators aim to recruit 20 participants (65 years and older) living with frailty. The investigators will recruit males and females as gender may influence sedentary behaviour through socially constructed norms and roles and can be affected by differential access to resources, opportunities, and power. The investigators are collaborating with geriatricians at Hamilton Health Sciences to recruit participants. The physician will inform eligible participants of the study and provide participants with a number to contact the research assistant. The research assistant will speak with interested participants to confirm eligibility and enroll them in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 60 years and older;\n2. Categorizes as frail on the FRAIL scale ≥ 3 of 5;\n3. Lives in the Greater Hamilton Area (GHA)\n4. Speaks English or can attend with a translator.\n\nExclusion Criteria:\n\n1. Requires a wheelchair at least 55% of the awake day; needs to sit for long periods of time due to a medical condition; or not independently mobile (i.e., requires assistance from another individual to ambulate);\n2. Has travel plans or other commitments that means missing \\>30% of the rollout study period;\n3. Unable to follow two-step instructions.'}, 'identificationModule': {'nctId': 'NCT05661058', 'acronym': 'MAPS-B', 'briefTitle': 'Mapping Sedentary Behaviour in Older Adults Who Are Frail', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'MAPping Sedentary Behaviour (MAPS-B) in Older Adults: A Mix-methods Longitudinal Study', 'orgStudyIdInfo': {'id': 'MAPSB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total number of participants', 'description': 'As this is not an intervention study, the investigators only have one group which the investigators will follow at two-time points to map the context of sedentary behaviour.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 4A6', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isabel Rodrigues', 'class': 'OTHER'}, 'collaborators': [{'name': 'McMaster University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Postdoctoral fellow', 'investigatorFullName': 'Isabel Rodrigues', 'investigatorAffiliation': 'McMaster University'}}}}