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

Primary Purpose

Frailty, Sedentary Behavior, Physical Disability

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Standing

About this trial

This is an interventional supportive care trial for Frailty focused on measuring Long Term Care, Physical Function

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pine Grove Nursing Home

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standing and Social Intervention

Control Group

Arm Description

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 will receive social visits, but no exposure to standing

Outcomes

Primary Outcome Measures

Changes in Walking Speed

Measured by the 10m walking speed test

Secondary Outcome Measures

Change in Balance

Measured by a portable device (Wii Balance board), which has sensors that detects sway .

Change in Leg Strength

Using hand-held dynamometer to quantify leg strength through knee extension

Change Lower Limb Power

Using the 30second sit-stand test following senior fitness test protocol

Change in Anxiety Symptoms

The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.

Depression

Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.

Loneliness

Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome

Fall Efficacy

Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score

Rate of Falls

Falls, injuries due to falls and hospitalization will be collected at 3 timepoints

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.

Social Behaviours

Semi-structured interviews with residents (participants and non-participants), family members and staff will be administered at the end of the study

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.

Metabolic Profile - Low Density Lipoprotein Cholesterol

Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).

Metabolic Profile - Blood Glucose

Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).

Full Information

NCT ID

NCT03796039

First Posted

December 20, 2018

Last Updated

May 31, 2023

Sponsor

University of New Brunswick

Collaborators

Horizon Health Network, St. Thomas University, Universite de Moncton, Canadian Frailty Network

1. Study Identification

Unique Protocol Identification Number

NCT03796039

Brief Title

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

Official Title

Stand if You Can- A Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

January 23, 2020 (Actual)

Study Completion Date

July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of New Brunswick

Collaborators

Horizon Health Network, St. Thomas University, Universite de Moncton, Canadian Frailty Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Frailty, Sedentary Behavior, Physical Disability

Keywords

Long Term Care, Physical Function

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standing and Social Intervention

Arm Type

Experimental

Arm Description

Participants be exposed to an additional 100 minutes of standing per week. Participants will do this by standing for 20 minutes Monday through Friday.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Control group will receive social visits, but no exposure to standing

Intervention Type

Behavioral

Intervention Name(s)

Standing

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in Walking Speed

Description

Measured by the 10m walking speed test

Time Frame

Pre and post intervention testing

Secondary Outcome Measure Information:

Title

Change in Balance

Description

Measured by a portable device (Wii Balance board), which has sensors that detects sway .

Time Frame

Pre and post testing (following the 5 month intervention). Data was collected but investigators are still analyzing findings.

Title

Change in Leg Strength

Description

Using hand-held dynamometer to quantify leg strength through knee extension

Time Frame