- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05661058
Mapping Sedentary Behaviour in Older Adults Who Are Frail (MAPS-B)
MAPping Sedentary Behaviour (MAPS-B) in Older Adults: A Mix-methods Longitudinal Study
Study Overview
Status
Conditions
Detailed Description
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.
Before 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Isabel Rodrigues, PhD
- Phone Number: 12464 905-521-2100
- Email: [email protected]
Study Locations
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Canada
-
Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 60 years and older;
- Categorizes as frail on the FRAIL scale ≥ 3 of 5;
- Lives in the Greater Hamilton Area (GHA)
- Speaks English or can attend with a translator.
Exclusion Criteria:
- 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);
- Has travel plans or other commitments that means missing >30% of the rollout study period;
- Unable to follow two-step instructions.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Total number of participants
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility process and resources
Time Frame: Two months
|
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.
|
Two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Focus group (Winter)
Time Frame: 1 day
|
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
|
1 day
|
Regression analysis (Winter)
Time Frame: 7 consecutive days
|
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).
|
7 consecutive days
|
Focus group (Spring)
Time Frame: 1 day
|
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
|
1 day
|
Regression analysis (Spring)
Time Frame: 3 consecutive days (2 weekdays and 1 weekend)
|
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).
|
3 consecutive days (2 weekdays and 1 weekend)
|
Context of sedentary behaviour (Winter)
Time Frame: Weekday #1
|
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.
|
Weekday #1
|
Context of sedentary behaviour (Winter)
Time Frame: Weekday #2
|
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.
|
Weekday #2
|
Context of sedentary behaviour (Winter)
Time Frame: Weekend #1
|
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.
|
Weekend #1
|
Context of sedentary behaviour (Spring)
Time Frame: Weekday #1
|
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.
|
Weekday #1
|
Context of sedentary behaviour (Spring)
Time Frame: Weekday #2
|
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.
|
Weekday #2
|
Context of sedentary behaviour (Spring)
Time Frame: Weekend #1
|
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.
|
Weekend #1
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAPSB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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