Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03796039
Other study ID # CAT2018-15
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04992286 - Detection, Evaluation and Monitoring of Frailties in the Elderly (FRAGING) N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04140890 - Supporting Habit Formation to Attenuate Prefrailty in Elders: Pilot Study N/A
Completed NCT04061785 - Impact of Skills Acquired Through Judo Training on Risk Factors for Falling in Elderly Men and Women N/A
Recruiting NCT03141866 - Seated Physical Activity in Ageing N/A
Completed NCT04888884 - Loss of Independence - a Rapid Alternative to Frailty Screening in a Swedish ED Setting
Recruiting NCT04145726 - Frailty In Thoracic Surgery for Esophageal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Not yet recruiting NCT06022666 - PATH Program for for Severely Frail or Cognitively Impaired Patients Scheduled for Cancer Surgery. N/A
Not yet recruiting NCT04514536 - Evaluation of a Health Monitoring Platform for Elderly in Home Care Context N/A
Completed NCT01126723 - Effects of Tai Chi on Frailty in Elderly Adults N/A
Completed NCT00183040 - HORMA: Hormonal Regulators of Muscle and Metabolism in Aging Phase 2
Active, not recruiting NCT05961319 - Smart Home Technologies for Assessing and Monitoring Frailty in Older Adults
Enrolling by invitation NCT05047731 - Antihypertensive Deprescribing in Long-term Care N/A
Completed NCT04956705 - Vitamin D and Calcium Supplementation at Danish Nursing Homes N/A
Recruiting NCT03824106 - Frailty Rehabilitation Phase 4
Recruiting NCT04518423 - Prevalence, Determinants and Natural History of Frailty and Pre-frailty in Elderly People
Completed NCT04087343 - Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults N/A