Stand if You Can: A Standing Intervention in Long Term Care

• ClinicalTrials.gov Identifier: NCT03796039
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Results First Posted: July 6, 2021
• Last Update Posted: July 13, 2021
• Sponsor: University of New Brunswick
• Collaborators: Horizon Health Network; St. Thomas University; Universite de Moncton; Canadian Frailty Network
• Information provided by (Responsible Party): Danielle Bouchard, University of New Brunswick

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Frailty; Sedentary Behavior; Physical Disability	Behavioral: Standing	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Investigator)
• Masking Description: 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
• Primary Purpose: Supportive Care
• Official Title: Stand if You Can- A Randomized Control Trial
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: January 23, 2020
• Actual Study Completion Date: July 15, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Standing; Standing for an additional 100 minutes per week; 20 minutes Monday-Friday
No Intervention: Control Group; Control group will receive social visits, but no exposure to standing

Outcome Measures

Primary Outcome Measures :

1. Changes in Walking Speed [ Time Frame: Pre and post intervention testing ]
   Measured by the 10m walking speed test

Secondary Outcome Measures :

1. Change in Balance [ Time Frame: Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings. ]
   Measured by a portable device (Wii Balance board), which has sensors that detects sway .
2. Change in Leg Strength [ Time Frame: Pre-Post Testing (following the 5 month intervention) ]
   Using hand-held dynamometer to quantify leg strength through knee extension
3. Change Lower Limb Power [ Time Frame: Pre-Post Testing (following the 5 month intervention) ]
   Using the 30second sit-stand test following senior fitness test protocol
4. Change in Anxiety Symptoms [ Time Frame: Pre-Post Testing (following the 5 month intervention) ]
   The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.
5. Depression [ Time Frame: Pre-Post Testing (following the 5 month intervention) ]
   Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.
6. Loneliness [ Time Frame: Pre-Post Testing (following the 5 month intervention) ]
   Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome
7. Fall Efficacy [ Time Frame: Pre-Post Testing (following the 5 month intervention) ]
   Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score
8. 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. ]
   Falls, injuries due to falls and hospitalization will be collected at 3 timepoints
9. Metabolic Profile - Triglycerides [ Time Frame: Pre-Post Testing (before and following the 5 month intervention). ]
   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.
10. Social Behaviours [ Time Frame: Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed ]
    Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study
11. Metabolic Profile - High Density Lipoprotein Cholesterol [ Time Frame: Pre and post testing (before and after the 5-month intervention) ]
    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.
12. Metabolic Profile - Low Density Lipoprotein Cholesterol [ Time Frame: Pre-Post intervention (before and after 5-month intervention) ]
    Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
13. Metabolic Profile - Blood Glucose [ Time Frame: Pre-Post Intervention (before and after 5-month intervention) ]
    Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• If Identified by staff at the facility as too high risk for falling by participating in the intervention.

Contacts and Locations

Locations

Canada, New Brunswick

Pine Grove Nursing Home

Fredericton, New Brunswick, Canada, E3B 2J2

Sponsors and Collaborators

University of New Brunswick

Horizon Health Network

St. Thomas University

Universite de Moncton

Canadian Frailty Network

  Study Documents (Full-Text)

Documents provided by Danielle Bouchard, University of New Brunswick:

Study Protocol and Statistical Analysis Plan  [PDF] May 1, 2020

More Information

• Responsible Party: Danielle Bouchard, Associate Investigator, University of New Brunswick
• ClinicalTrials.gov Identifier: NCT03796039
• Other Study ID Numbers: CAT2018-15
• First Posted: January 8, 2019
• Results First Posted: July 6, 2021
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Danielle Bouchard, University of New Brunswick:

Long Term Care; Physical Function

Additional relevant MeSH terms:

Frailty; Pathologic Processes