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Sedentary BehaviorNCT04458896

Stand When You Can: 6-week Pilot Study to Reduce Sedentary Time in Assisted Living

A study testing Stand When You Can in people with Sedentary Behavior and Aging, run by University of Lethbridge at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Sedentary Behavior, Aging
What is being tested?
Stand When You Can
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
28 Jan 2019to 30 Apr 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Lethbridge

    Lethbridge, Alberta, T1K3M4

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Stand When You Can
Keywords
assisted living, physical function, Social Ecological Model
Medical subject headings
Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stand When You CanBehavioural

    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
Study groups in NCT04458896
Study groupRoleWhat they receive
Stand When You CanExperimentalThe 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.
Receives: Behavioral: Stand When You Can

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. 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.

    Measured: 6 weeks

  6. 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.

    Measured: 6 weeks

Secondary outcomes (2)
  1. Program feasibility

    The investigators will collect feedback forms from residents after the 6-week intervention to gain an understanding of which strategies were used most frequently and how much they liked or disliked the different components of the intervention. Survey responses will be displayed in frequency tables.

    Measured: 6 weeks

  2. Program Feedback Interviews with Staff

    The investigators will interview the staff to receive staff feedback about ways the program could improve for future iterations. Feedback questions include what components seem to resonate with residents, which components were not utilized, and any other strategies the investigators could leverage to improve delivery and support. All staff will provide written informed consent prior to the interview.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start28 Jan 2019
  3. Primary completion30 Apr 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Non-randomized trial
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458896
Sponsor's protocol ID
2019-001
Status last verified
Jul 2020
First submitted
25 Jun 2020
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data of device-measured and self-reported sedentary time, physical function and quality of life measures

Publications

  • 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.

    PubMed 32762644

Questions about this trial

What is this clinical trial studying?

A study testing Stand When You Can in people with Sedentary Behavior and Aging, run by University of Lethbridge at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily time spent sedentary measured by activPAL4™ inclinometers (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04458896, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.

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