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| Name | Class |
|---|---|
| Horizon Health Network | OTHER |
| St. Thomas University | OTHER |
| Universite de Moncton | OTHER |
| Canadian Frailty Network |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group | No Intervention | Control group will receive social visits, but no exposure to standing |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standing | Behavioral | Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Walking Speed | Measured by the 10m walking speed test | Pre and post intervention testing |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Balance | Measured by a portable device (Wii Balance board), which has sensors that detects sway . | Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings. |
| Change in Leg Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pine Grove Nursing Home | Fredericton | New Brunswick | E3B 2J2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40469490 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standing and Social Intervention | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday. Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
| FG001 | Control Group | Control group will receive social visits, but no exposure to standing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standing and Social Intervention | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday. Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Walking Speed | Measured by the 10m walking speed test | Posted | Mean | Standard Deviation | m/s | Pre and post intervention testing |
|
During trial (5 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standing and Social Intervention | Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday. Standing: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle Bouchard | University of New Brunswick | (506) 443-3908 | dboucha1@unb.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2020 | Dec 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| D057185 | Sedentary Behavior |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000078783 | Standing Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| OTHER |
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).
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Investigator was masked at pre-testing. It was unknown which participants would be receiving the intervention. However, due to resources this was not repeated at post testing
Using hand-held dynamometer to quantify leg strength through knee extension |
| Pre-Post Testing (following the 5 month intervention) |
| Change Lower Limb Power | Using the 30second sit-stand test following senior fitness test protocol | 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. | Pre-Post Testing (following the 5 month intervention) |
| Depression | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | 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 | Pre-Post Testing (following the 5 month intervention) |
| Fall Efficacy | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | Pre-Post Testing (following the 5 month intervention) |
| Rate of Falls | Falls, injuries due to falls and hospitalization will be collected at 3 timepoints | 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. | 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 | 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. | 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). | 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). | Pre-Post Intervention (before and after 5-month intervention) |
Control group will receive social visits, but no exposure to standing |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Frailty | Frailty was measured using the Clinical Frailty Scale (1-9). 1 indicates very fit, 9 indicates terminally ill. LTC staff were asked to rate participants at pre and post intervention | Mean | Standard Deviation | units on a scale |
|
| Transfer Status (Independent Transfer) | Transfer status was assessed by LTC staff following jurisdiction regulations (Work Safe New Brunswick). It is assessed upon admission, quarterly (90 days) and when a significant change in health status occurs (e.g., fall, stroke). For our study, we used the most recent Transfer status update. Residents were categorized as requiring no assistance to transfer from sit to stand (independent), requiring staff assistance to stand (assisted transfer), or requiring staff and mechanical assistance to stand (dependent). | Count of Participants | Participants |
|
| Length of stay in LTC | Mean | Standard Deviation | years |
|
| Cognition (MMSE) | The mini-mental state examination was administered by research assistants at baseline to assess cognition. Scored out of 30, the questionnaire categorized a person as having none, mild or severe cognitive impairment. A score of 0-17 indicates severe cognitive impairment, 18-23 as mild, and 24-30 as no cognitive impairment. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change in Balance | Measured by a portable device (Wii Balance board), which has sensors that detects sway . | Not Posted | Sep 2024 | Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings. | Participants |
| Secondary | Change in Leg Strength | Using hand-held dynamometer to quantify leg strength through knee extension | Posted | Mean | Standard Deviation | kg | Pre-Post Testing (following the 5 month intervention) |
|
|
|
| Secondary | Change Lower Limb Power | Using the 30second sit-stand test following senior fitness test protocol | Posted | Mean | Standard Deviation | Number of repetitions | Pre-Post Testing (following the 5 month intervention) |
|
|
|
| Secondary | Change in Anxiety Symptoms | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. | Only participants with MMSE score greater than or equal to 18 were included (to ensure participants had the cognitive abilities to respond to the questionnaires) | Posted | Mean | Standard Deviation | units on a scale | Pre-Post Testing (following the 5 month intervention) |
|
|
|
| Secondary | Depression | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. | Only participants with a MMSE score of 18 or higher were included | Posted | Mean | Standard Deviation | score on a scale | Pre-Post Testing (following the 5 month intervention) |
|
|
|
| Secondary | Loneliness | Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome | Participants only included if MMSE score is equal to or greater than 18. | Posted | Mean | Standard Deviation | score on a scale | Pre-Post Testing (following the 5 month intervention) |
|
|
|
| Secondary | Fall Efficacy | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score | This was only measured among participants who had a MMSE score of 18 or higher (to ensure they had the cognitive capacity to properly answer the questionnaire) | Posted | Mean | Standard Deviation | score on a scale | Pre-Post Testing (following the 5 month intervention) |
|
|
|
| Secondary | Rate of Falls | Falls, injuries due to falls and hospitalization will be collected at 3 timepoints | Not Posted | Sep 2024 | 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. | Participants |
| Secondary | 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. | Blood draws were difficult among this population due to participant agitation, therefore we were not able to collect blood for all participants | Posted | Mean | Standard Deviation | mmol/L | Pre-Post Testing (before and following the 5 month intervention). |
|
|
|
| Secondary | Social Behaviours | Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study | Not Posted | Sep 2024 | Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed | Participants |
| Secondary | 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. | Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal) | Posted | Mean | Standard Deviation | mmol/L | Pre and post testing (before and after the 5-month intervention) |
|
|
|
| Secondary | Metabolic Profile - Low Density Lipoprotein Cholesterol | Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal) | Posted | Mean | Standard Deviation | mmol/L | Pre-Post intervention (before and after 5-month intervention) |
|
|
|
| Secondary | Metabolic Profile - Blood Glucose | Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). | Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal) | Posted | Mean | Standard Deviation | mmol/L | Pre-Post Intervention (before and after 5-month intervention) |
|
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|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Control Group | Control group will receive social visits, but no exposure to standing | 0 | 47 | 0 | 47 | 0 | 47 |
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