Clinical trial NCT03796039: Stand if You Can: A Standing Intervention in Long Term Care
Official title: Stand if You Can- A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Sedentary Behavior
Physical Disability
Keywords: Long Term Care
Physical Function
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: Horizon Health Network
name: St. Thomas University
name: Universite de Moncton
name: Canadian Frailty Network
First posted: 2019-01-08
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Walking Speed
timeFrame: Pre and post intervention testing
Secondary outcomes:
measure: Change in Balance
timeFrame: Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.
measure: Change in Leg Strength
timeFrame: Pre-Post Testing (following the 5 month intervention)
measure: Change Lower Limb Power
timeFrame: Pre-Post Testing (following the 5 month intervention)
measure: Change in Anxiety Symptoms
timeFrame: Pre-Post Testing (following the 5 month intervention)
measure: Depression
timeFrame: Pre-Post Testing (following the 5 month intervention)
measure: Loneliness
timeFrame: Pre-Post Testing (following the 5 month intervention)
measure: Fall Efficacy
timeFrame: Pre-Post Testing (following the 5 month intervention)
measure: Rate of Falls
timeFrame: 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.
measure: Metabolic Profile - Triglycerides
timeFrame: Pre-Post Testing (before and following the 5 month intervention).
measure: Social Behaviours
timeFrame: Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed
measure: Metabolic Profile - High Density Lipoprotein Cholesterol
timeFrame: Pre and post testing (before and after the 5-month intervention)
measure: Metabolic Profile - Low Density Lipoprotein Cholesterol
timeFrame: Pre-Post intervention (before and after 5-month intervention)
measure: Metabolic Profile - Blood Glucose
timeFrame: Pre-Post Intervention (before and after 5-month intervention)
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: Pine Grove Nursing Home
state: New Brunswick
Study officials:
References: