FrailtyNCT03796039
Stand if You Can: A Standing Intervention in Long Term Care
A study testing Standing in people with Frailty and Sedentary Behavior, run by University of New Brunswick at 1 site in Canada.
Trial summary
It is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (LTC) facilities, is associated with an improvement in physical capacity such as walking speed. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sedentary Behavior, Physical Disability
- What is being tested?
- Standing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident at one of the selected LTC facilities;
- Able to provide consent or have a power of attorney agree on behalf of a resident to participate in the study;
- Able to walk for ten meters, with or without a walking aid; The main outcome is walking speed performed for a distance of 10 meters. Therefore, we want everyone who participates in the study to be able to complete the test at baseline. This way we can answer the main research question, while adhering to our sample size calculation.
Who cannot join
- If Identified by staff at the facility as too high risk for falling by participating in the intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stand if You Can- A Randomized Control Trial
It is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (LTC) facilities, is associated with an improvement in physical capacity such as walking speed. Simple tasks such as walking speed is associated with important outcomes for residents in LTC such as autonomy and hospitalization. The investigators hypothesize that standing an additional 100 minutes per week for 5 months will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC residents compared to residents receiving a sitting social activity.
Read the detailed description
LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC facilities randomized as the intervention and half as the control group. The investigators are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88 residents (44 in the control group, 44 in the intervention group) will be enrolled in the program.
- Conditions
- Frailty, Sedentary Behavior, Physical Disability
- Being tested
- Standing
- Keywords
- Long Term Care, Physical Function
- Medical subject headings
- Frailty, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StandingBehavioural
Standing for an additional 100 minutes per week; 20 minutes Monday-Friday
| Study group | Role | What they receive |
|---|---|---|
| Standing and Social Intervention | Experimental | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday. Receives: Behavioral: Standing |
| Control Group | No intervention | Control group will receive social visits, but no exposure to standing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Walking Speed
Measured by the 10m walking speed test
Measured: Pre and post intervention testing
Secondary outcomes (13)
Change in Balance
Measured by a portable device (Wii Balance board), which has sensors that detects sway .
Measured: Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.
Change in Leg Strength
Using hand-held dynamometer to quantify leg strength through knee extension
Measured: Pre-Post Testing (following the 5 month intervention)
Change Lower Limb Power
Using the 30second sit-stand test following senior fitness test protocol
Measured: Pre-Post Testing (following the 5 month intervention)
Change in Anxiety Symptoms
The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.
Measured: Pre-Post Testing (following the 5 month intervention)
Depression
Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.
Measured: Pre-Post Testing (following the 5 month intervention)
Loneliness
Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome
Measured: Pre-Post Testing (following the 5 month intervention)
Fall Efficacy
Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score
Measured: Pre-Post Testing (following the 5 month intervention)
Rate of Falls
Falls, injuries due to falls and hospitalization will be collected at 3 timepoints
Measured: The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time.
Metabolic Profile - Triglycerides
Capillary blood analyzed with a cardiochek device. Blood collected via a finger prick and analyzed with a cardiochek device. Note that Total Cholesterol, HDL, Triglycerides, LDL and Glucose were all measured using the cardiochek device.
Measured: Pre-Post Testing (before and following the 5 month intervention).
Social Behaviours
Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study
Measured: Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed
Metabolic Profile - High Density Lipoprotein Cholesterol
High Density Lipoprotein (HDL) cholesterol was analyzed using the CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). A finger prick was conducted using a single use lancet and approximately 60 µL of whole blood was collected for this test.
Measured: Pre and post testing (before and after the 5-month intervention)
Metabolic Profile - Low Density Lipoprotein Cholesterol
Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
Measured: Pre-Post intervention (before and after 5-month intervention)
Metabolic Profile - Blood Glucose
Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
Measured: Pre-Post Intervention (before and after 5-month intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Apr 2019
- Primary completion23 Jan 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Long term care (LTC) facilities will be recruited, with half of the LTC facilities randomized as the intervention (n=2) and half as the control group (n=2).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Brunswick
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon Health Network, St. Thomas University, Universite de Moncton, Canadian Frailty Network
- Responsible party
- Principal investigator, Danielle Bouchard, University of New Brunswick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796039
- Sponsor's protocol ID
- CAT2018-15
- Status last verified
- May 2023
- First submitted
- 20 Dec 2018
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cooling K, Bouchard DR, Gallibois M, Hebert J, Senechal M, Jarrett P, McGibbon C, Richard E, Handrigan G. Stand if you can- A parallel, superiority cluster randomized controlled trial to improve gait speed for long term care residents. JAR Life. 2025 May 9;14:100015. doi: 10.1016/j.jarlif.2025.100015. eCollection 2025.
PubMed 40469490
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stand if You Can- A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03796039
- Acronym / sponsor ID
- CAT2018-15
- Conditions
- Frailty, Sedentary Behavior, Physical Disability
- Keywords
- Long Term Care, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of New BrunswickUniversity, hospital or other
- Collaborators
- Horizon Health Network, St. Thomas University, Universite de Moncton, Canadian Frailty Network
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 23 Jan 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 6 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is currently unknown if reducing sitting time, an activity that is highly prevalent in frail older adults living in long term care (LTC) facilities, is associated with an improvement in physical capacity such as walking speed. Simple tasks such as walking speed is associated with important outcomes for residents in LTC such as autonomy and hospitalization. The investigators hypothesize that standing an additional 100 minutes per week for 5 months will result in a clinically meaningful improvement in walking speed (0.1m/sec) in LTC residents compared to residents receiving a sitting social activity.
Detailed description
LTC facilities from Moncton and Fredericton will be recruited, with half of the LTC facilities randomized as the intervention and half as the control group. The investigators are aiming to enrol half of the LTC in Fredericton and half in Moncton. A total of 88 residents (44 in the control group, 44 in the intervention group) will be enrolled in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Long term care (LTC) facilities will be recruited, with half of the LTC facilities randomized as the intervention (n=2) and half as the control group (n=2).
| Arm | Type | Receives |
|---|---|---|
| Standing and Social Intervention | Experimental | Behavioral: StandingParticipants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday. |
| Control Group | No intervention | –Control group will receive social visits, but no exposure to standing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Resident at one of the selected LTC facilities;
- Able to provide consent or have a power of attorney agree on behalf of a resident to participate in the study;
- Able to walk for ten meters, with or without a walking aid; The main outcome is walking speed performed for a distance of 10 meters. Therefore, we want everyone who participates in the study to be able to complete the test at baseline. This way we can answer the main research question, while adhering to our sample size calculation.
Key exclusion criteria (1 listed)
- If Identified by staff at the facility as too high risk for falling by participating in the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StandingStanding for an additional 100 minutes per week; 20 minutes Monday-Friday | Behavioural | Standing and Social Intervention |
Primary outcome
Changes in Walking Speed
Time frame: Pre and post intervention testing
Measured by the 10m walking speed test
13 secondary outcomes
Change in Balance
Time frame: Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.
Change in Leg Strength
Time frame: Pre-Post Testing (following the 5 month intervention)
Change Lower Limb Power
Time frame: Pre-Post Testing (following the 5 month intervention)
Change in Anxiety Symptoms
Time frame: Pre-Post Testing (following the 5 month intervention)
Depression
Time frame: Pre-Post Testing (following the 5 month intervention)
Loneliness
Time frame: Pre-Post Testing (following the 5 month intervention)
Fall Efficacy
Time frame: Pre-Post Testing (following the 5 month intervention)
Rate of Falls
Time frame: The number of falls will be collected from three timeframes: 1. Between 6 months prior to and the start of program 2. the duration of the program (5 months) 3. From the end of the program to 6 months follow up. Data is still being analyzed at this time.
Metabolic Profile - Triglycerides
Time frame: Pre-Post Testing (before and following the 5 month intervention).
Social Behaviours
Time frame: Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed
Metabolic Profile - High Density Lipoprotein Cholesterol
Time frame: Pre and post testing (before and after the 5-month intervention)
Metabolic Profile - Low Density Lipoprotein Cholesterol
Time frame: Pre-Post intervention (before and after 5-month intervention)
Metabolic Profile - Blood Glucose
Time frame: Pre-Post Intervention (before and after 5-month intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40469490Cooling K, Bouchard DR, Gallibois M, Hebert J, Senechal M, Jarrett P, McGibbon C, Richard E, Handrigan G. Stand if you can- A parallel, superiority cluster randomized controlled trial to improve gait speed for long term care residents. JAR Life. 2025 May 9;14:100015. doi: 10.1016/j.jarlif.2025.100015. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standing in people with Frailty and Sedentary Behavior, run by University of New Brunswick 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 1 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 27 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 6 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Walking Speed (time frame: Pre and post intervention testing). 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 NCT03796039, 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 27 Jun 2023.