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

Frailty Clinical Trial

Official title:

Stand if You Can- A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796039
• Other study ID #: CAT2018-15
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: July 15, 2020

Study information

• Verified date: May 2023
• Source: University of New Brunswick
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: July 15, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Physical Disability
• Sedentary Behavior

Intervention

Behavioral:
• Standing
Standing for an additional 100 minutes per week; 20 minutes Monday-Friday

Locations

Country	Name	City	State
Canada	Pine Grove Nursing Home	Fredericton	New Brunswick

Sponsors (5)

Lead Sponsor	Collaborator
University of New Brunswick	Canadian Frailty Network, Horizon Health Network, St. Thomas University, Universite de Moncton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Walking Speed	Measured by the 10m walking speed test	Pre and post intervention testing
Secondary	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.
Secondary	Change in Leg Strength	Using hand-held dynamometer to quantify leg strength through knee extension	Pre-Post Testing (following the 5 month intervention)
Secondary	Change Lower Limb Power	Using the 30second sit-stand test following senior fitness test protocol	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.	Pre-Post Testing (following the 5 month intervention)
Secondary	Depression	Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.	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	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	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	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.
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.	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	Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed
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.	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).	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).	Pre-Post Intervention (before and after 5-month intervention)