Clinical trial NCT04458896: Stand When You Can: 6-week Pilot Study to Reduce Sedentary Time in Assisted Living
Official title: Stand When You Can: 6-week Pilot Study to Reduce Sedentary Time in Assisted Living
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Behavior
Aging
Keywords: assisted living
physical function
Social Ecological Model
Lead sponsor: University of Lethbridge
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomized trial
Primary purpose: PREVENTION

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.

Detailed description: This is a voluntary single-arm uncontrolled trial in assisted living residences. Pre- and post- intervention assessments will be conducted over two sessions; the intervention period is 6 weeks.

First session:

In the first session participants will complete informed consent, compete all questionnaires, and be fitted with the active PALs for measuring sedentary time. This should take approximately 30-60 minutes. The second session will be 7 days later, and the investigators will retrieve the ActivPAL inclinometer and then complete the Short Performance Physical Battery. This should take 20-30 minutes. Health-related quality of Life will be assessed using the Euro Quality of Life 5 dimension questionnaire (EQ-5D). This is a generic health status questionnaire (i.e. it is not disease specific) and consists of a descriptive system and a visual analogue scale (VAS). Five dimensions are included: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It is widely used and has good reliability. General Quality of Life will be assessed using the ICEpop CAPability measure for Older people (ICECAP-O). The ICECAP-O has a broad view of quality of life and covers the domains of attachment (love and friendship), security (thinking about the future without concern), role (doing things that make participants feel valued), enjoyment (enjoyment and pleasure), and control (independence). Both questionnaires are attached and the estimated time for completion is about 10 minutes.Sedentary time will be with an activPAL4™ inclinometer and the Longitudinal Aging Study Amsterdam (LASA) self-report sedentary behaviour questionnaire. The activPAL4™ device is enclosed in a nitrile sleeve and secured to the thigh using medical tape. Skin will be monitored for irritation. Both the finger cots and the nitrile sleeves are single use. The activPAL4™ inclinometers are only 9 grams and 5mm thick, making them comfortable for 7-day wear on the thigh. Using proprietary algorithms and software, it classifies an individual's free-living activity into periods spent sleeping, sitting, standing and ambulating as well as step counts, activity start time and activity duration. This allows for quantification of these movement behaviours over 24 hours. The unit will be worn for 7 days to determine the pre-intervention movement profile. Mid-way through the 7 day period researchers will check in with participants to ensure there are no problems. These devices have been used extensively with older adults in previous research.

The LASA sedentary behavior questionnaire is moderately associated with accelerometer-measured sedentary time (r=.46) and reliably ranks sedentary time in older adults. While self-report tools underestimate total sedentary time, they provide valuable information about the context (eg. where or with whom) and type (eg. reading or watching TV) of sedentary behaviours, which will be valuable for evaluating the intervention. (See attachments for a copy of the questionnaire).

Second Session:

Blood pressure in mmHg and heart rate in beats per minute will be measured at rest in a seated position. If Blood Pressure exceeds 160/90 mmHg or heart rate exceeds 99 beats per minute, the participants will not complete the SPPB described below. These will be measured using an automated sphygmomanometer. Height in centimetres and weight in kilograms will be measured using an electronic scale and stadiometer.Participants will be asked to refrain from smoking or consuming caffeine for 2 hours before the appointment and avoid exercise or strenuous physical activity the day of the assessment. The Short Performance Physical Battery (SPPB) will be used to assess physical function. The SPPB is an objective assessment tool for evaluating lower extremity functioning in older persons and it includes assessments of gait speed, standing balance, and timed chair rises (see attachment for details). It was developed by the National Institute on Aging and has been shown to have high validity and reliability in measuring physical function in older adults. The participants will also measure grip strength by having participants grasp a hand grip dynamometer and squeezing as hard as possible, with each hand. The entire battery of tests will be conducted in a circuit format and will take ≤20 minutes to complete.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Daily time spent sedentary measured by activPAL4™ inclinometers
timeFrame: 6 weeks
measure: Physical function of The lower extremities measured by the Short Physical Performance Battery
timeFrame: 6 weeks
measure: Quality of Life measured by the EQ-5D-5L
timeFrame: 6 weeks
measure: Upper body strength measured by grip strength
timeFrame: 6 weeks
measure: Quality of Life measured by the ICEpop CAPability Measure for Older People Scale
timeFrame: 6 weeks
measure: Self-reported time spent in sedentary behaviour measured by the LASA Sedentary Behaviour Questionnaire
timeFrame: 6 weeks
Secondary outcomes:
measure: Program feasibility
timeFrame: 6 weeks
measure: Program Feedback Interviews with Staff
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lethbridge
country: Canada
facility: University of Lethbridge
state: Alberta
Study officials:
affiliation: University of Lethbridge
name: Jennifer Copeland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.