NCT04458896

Brief Summary

Prolonged daily sedentary time is associated with increased risk of cardiometabolic diseases, impaired physical function, and mortality. Older adults are more sedentary than any other age group and those in assisted living residences accumulate even more sedentary time as they often have little need to engage in light-intensity or standing activities such as cleaning or meal preparation. This "low movement" environment can hasten functional decline. Thus, the purpose of this study was to develop a multi-level intervention to reduce and interrupt sedentary time within assisted living residences and conduct a pilot study to determine if the intervention is feasible and if further testing is warranted.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

June 25, 2020

Last Update Submit

July 6, 2020

Conditions

Keywords

assisted livingphysical functionSocial Ecological Model

Outcome Measures

Primary Outcomes (6)

  • Daily time spent sedentary measured by activPAL4™ inclinometers

    Sedentary time in minutes per day will be assessed with the activPAL4™ inclinometer which measures movement patterns and body posture 24 hours/day and can monitor body positions, making them useful for measuring sedentary time. activPALs have been found to be valid and reliable in comparison to direct observation (R2 = 0.94). The activPAL4s were waterproofed using a nitrile sleeve and affixed to the thigh using Tegaderm (3M Medical, USA).

    6 weeks

  • Physical function of The lower extremities measured by the Short Physical Performance Battery

    The Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older adults and it includes assessments of gait speed (4 m walk), standing balance (side by side, semi-tandem, and tandem), and 5 timed chair rises. The SPPB has been shown to have good predictive and concurrent validity and reliability (intraclass correlation coefficient \> 0.70) in measuring physical function in older adults and is also predictive of mobility impairment. A maximum score of 12 represents good physical function.

    6 weeks

  • Quality of Life measured by the EQ-5D-5L

    The EQ-5D-5L is a generic measure of health status that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, along a five-point scale (no problems, slight problems, moderate, severe, and unable to do the action/extreme). These questions create a health state which will be translated to a summary index value using the Crosswalk Index Value Calculator (US values, euroqol.org). A value of 1 represents the best possible health state, with health states diminishing as they approach zero. It also includes a visual analogue scale for overall health anchored between 0 (worst health imaginable) to 100 (best health imaginable). The EQ-5D-5L has a discriminatory power of 0.68 and a test-retest reliability of 0.69.

    6 weeks

  • Upper body strength measured by grip strength

    Grip strength will be measured in kilograms using a dynamometer (Creative Health Products Inc, USA) following Canadian Society of Exercise Physiology testing guidelines. Two trials will be completed by either hand and the best score from either hand will be combined into one score. A higher score represents better strength.

    6 weeks

  • Quality of Life measured by the ICEpop CAPability Measure for Older People Scale

    The ICECAP-O is a broader measure of quality of life that does not focus on physical health but covers the domains of attachment, security, role, enjoyment, and control. The ICECAP-O has been shown to be reliable and have good construct validity as a measure of quality of life. A score is calculated between 0 and 1 with 0 representing no capability (e.g. death) and 1 representing maximum capability.

    6 weeks

  • Self-reported time spent in sedentary behaviour measured by the LASA Sedentary Behaviour Questionnaire

    The Longitudinal Aging Study Amsterdam (LASA) Sedentary Behaviour Questionnaire estimates self-reported sedentary time by asking participants about time (hours:minutes) spent in 10 sitting behaviours on an average weekday or weekend day. The questionnaire has a test-retest reliability of 0.71 (95% CI 0.57-0.81) but may underestimate total sedentary time by as much as 2.1 hours. The six domains of napping, reading, listening to music, watching TV, engaging in seated hobbies, and talking to friends had the highest correlation with device-measured sedentary time. Thus, the investigators will only include these six domains when calculating self-reported sedentary time.

    6 weeks

Secondary Outcomes (2)

  • Program feasibility

    6 weeks

  • Program Feedback Interviews with Staff

    6 weeks

Study Arms (1)

Stand When You Can

EXPERIMENTAL

The intervention is grounded in Social Cognitive Theory and the Social Ecological Model (SEM). Multiple levels of the SEM will be targeted (individual, environmental, and organizational) over 6 weeks.

Behavioral: Stand When You Can

Interventions

Intervention strategies can be customized to different environments based on consultation with management. Some strategies will be mandatory: * Education session: group information session during the first week of the intervention (30min) to discuss sedentary time (ST), health risks, strategies to reduce ST, goal setting, \& the identification of barriers and motivators to reducing ST. Group discussion will be encouraged to increase self-motivation and self-efficacy. An information "workbook" will be given to each attendee for their personal use and goal setting. * Point of decision prompts (ie: signs that encourage standing; see attachments) will be placed in common areas of the facility, and/or given as pamphlets to residents. * An intervention package will be provided to the Activity Coordinator and Manager of the facility. This package will provide an introductory letter along with materials to promote reduced sedentary time in the facility

Stand When You Can

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • independently mobile residents of assisted living communities 65 years or older
  • able to read and write in English
  • able to provide informed consent

You may not qualify if:

  • do not have a diagnosed cognitive impairment
  • expecting to have a medical procedure that would require more than 1 week of rest during the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lethbridge

Lethbridge, Alberta, T1K3M4, Canada

Location

Related Publications (1)

  • Voss ML, Pope JP, Larouche R, Copeland JL. Stand When You Can: development and pilot testing of an intervention to reduce sedentary time in assisted living. BMC Geriatr. 2020 Aug 6;20(1):277. doi: 10.1186/s12877-020-01647-z.

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jennifer Copeland, PhD

    University of Lethbridge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Non-randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 7, 2020

Study Start

January 28, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

July 8, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Anonymized data of device-measured and self-reported sedentary time, physical function and quality of life measures

Time Frame
10 years (2030)
Access Criteria
Email Dr. Copeland for access

Locations