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

May 31, 2023 updated by: Danielle Bouchard, University of New Brunswick

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 2J2
        • Pine Grove Nursing Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Walking Speed
Time Frame: Pre and post intervention testing
Measured by the 10m walking speed test
Pre and post intervention testing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
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)
Using hand-held dynamometer to quantify leg strength through knee extension
Pre-Post Testing (following the 5 month intervention)
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
Pre-Post Testing (following the 5 month intervention)
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.
Pre-Post Testing (following the 5 month intervention)
Depression
Time Frame: Pre-Post Testing (following the 5 month intervention)
Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.
Pre-Post Testing (following the 5 month intervention)
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
Pre-Post Testing (following the 5 month intervention)
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
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.
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
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.
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
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
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.
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)
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
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).
Pre-Post Intervention (before and after 5-month intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

July 15, 2020

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

January 3, 2019

First Posted (Actual)

January 8, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT2018-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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