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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05661058
Other study ID # MAPSB
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 13, 2023
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 60 Years to 105 Years
Eligibility Inclusion Criteria: 1. 60 years and older; 2. Categorizes as frail on the FRAIL scale = 3 of 5; 3. Lives in the Greater Hamilton Area (GHA) 4. Speaks English or can attend with a translator. Exclusion Criteria: 1. 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); 2. Has travel plans or other commitments that means missing >30% of the rollout study period; 3. Unable to follow two-step instructions.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Hamilton Ontario

Sponsors (2)

Lead Sponsor Collaborator
Isabel Rodrigues McMaster University

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View 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 2 — View 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. — View 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: 10.10 — View 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. — View 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. — View 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. — View 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. — View 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/Nat — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility process and resources 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 Focus group (Winter) 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
Secondary Regression analysis (Winter) 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
Secondary Focus group (Spring) 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
Secondary Regression analysis (Spring) 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)
Secondary Context of sedentary behaviour (Winter) 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
Secondary Context of sedentary behaviour (Winter) 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
Secondary Context of sedentary behaviour (Winter) 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
Secondary Context of sedentary behaviour (Spring) 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
Secondary Context of sedentary behaviour (Spring) 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
Secondary Context of sedentary behaviour (Spring) 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
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