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Completed

NCT Number: NCT03796039

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

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.

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Key information

Conditions

Frailty Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Physical Disability Sedentary Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pine Grove Nursing Home

Fredericton, New Brunswick, E3B 2J2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standing

Behavioral

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

Primary outcomes

  1. Changes in Walking Speed

    Time frame: Pre and post intervention testing

    Measured by the 10m walking speed test

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of New Brunswick

Other

Collaborators

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

Registry information

Official study title

Stand if You Can- A Randomized Control Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2019
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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