Frailty, Sedentary Behavior, Physical Disability
Conditions
Keywords
Long Term Care, Physical Function
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.
Interventions
BEHAVIORALStanding
Standing for an additional 100 minutes per week; 20 minutes Monday-Friday
Sponsors
Horizon Health Network
St. Thomas University
Universite de Moncton
Canadian Frailty Network
University of New Brunswick
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (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
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).
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Walking Speed | Pre and post intervention testing | Measured by the 10m walking speed test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change Lower Limb Power | Pre-Post Testing (following the 5 month intervention) | Using the 30second sit-stand test following senior fitness test protocol |
| Change in Balance | 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 . |
| Change in Leg Strength | Pre-Post Testing (following the 5 month intervention) | Using hand-held dynamometer to quantify leg strength through knee extension |
| Depression | Pre-Post Testing (following the 5 month intervention) | Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome. |
| Loneliness | 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 |
| Fall Efficacy | Pre-Post Testing (following the 5 month intervention) | Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score |
| Change in Anxiety Symptoms | Pre-Post Testing (following the 5 month intervention) | The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome. |
| Metabolic Profile - Triglycerides | 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. |
| Social Behaviours | 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 |
| Metabolic Profile - High Density Lipoprotein Cholesterol | 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. |
| Metabolic Profile - Low Density Lipoprotein Cholesterol | 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). |
| Metabolic Profile - Blood Glucose | 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). |
| Rate of Falls | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: Standing for an additional 100 minutes per week; 20 minutes Monday-Friday | 50 |
| Control Group Control group will receive social visits, but no exposure to standing | 47 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 4 |
Baseline characteristics
| Characteristic | Standing and Social Intervention | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 87.14 years STANDARD_DEVIATION 8.46 | 85.11 years STANDARD_DEVIATION 7.63 | 86 years STANDARD_DEVIATION 8 |
| BMI | 26.93 kg/m2 STANDARD_DEVIATION 6.53 | 25.56 kg/m2 STANDARD_DEVIATION 9.01 | 26.2 kg/m2 STANDARD_DEVIATION 7.8 |
| Cognition (MMSE) | 15.76 units on a scale STANDARD_DEVIATION 9.2 | 17.7 units on a scale STANDARD_DEVIATION 8.8 | 16.7 units on a scale STANDARD_DEVIATION 9 |
| Frailty | 6 units on a scale STANDARD_DEVIATION 1.5 | 6.13 units on a scale STANDARD_DEVIATION 0.8 | 6.1 units on a scale STANDARD_DEVIATION 1.2 |
| Length of stay in LTC | 4.6 years STANDARD_DEVIATION 5.4 | 3.9 years STANDARD_DEVIATION 3.5 | 4.2 years STANDARD_DEVIATION 4.5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 37 Participants | 31 Participants | 68 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 29 Participants |
| Transfer Status (Independent Transfer) | 8 Participants | 25 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 47 |
| other Total, other adverse events | 1 / 50 | 0 / 47 |
| serious Total, serious adverse events | 0 / 50 | 0 / 47 |
Outcome results
Primary
Changes in Walking Speed
Measured by the 10m walking speed test
Time frame: Pre and post intervention testing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Changes in Walking Speed | Pre | 0.34 m/s | Standard Deviation 0.17 |
| Standing and Social Intervention | Changes in Walking Speed | Post | 0.35 m/s | Standard Deviation 0.2 |
| Control Group | Changes in Walking Speed | Pre | 0.43 m/s | Standard Deviation 0.2 |
| Control Group | Changes in Walking Speed | Post | 0.40 m/s | Standard Deviation 0.2 |
Secondary
Change in Anxiety Symptoms
The Geriatric Anxiety Inventory (Scale 0-20). A low score means a better outcome.
Time frame: Pre-Post Testing (following the 5 month intervention)
Population: Only participants with MMSE score greater than or equal to 18 were included (to ensure participants had the cognitive abilities to respond to the questionnaires)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Change in Anxiety Symptoms | Pre | 6.1 units on a scale | Standard Deviation 7.2 |
| Standing and Social Intervention | Change in Anxiety Symptoms | Post | 6.7 units on a scale | Standard Deviation 7.1 |
| Control Group | Change in Anxiety Symptoms | Pre | 6.6 units on a scale | Standard Deviation 6 |
| Control Group | Change in Anxiety Symptoms | Post | 6.6 units on a scale | Standard Deviation 6.1 |
Secondary
Change in Balance
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.
Secondary
Change in Leg Strength
Using hand-held dynamometer to quantify leg strength through knee extension
Time frame: Pre-Post Testing (following the 5 month intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Change in Leg Strength | Pre | 9.48 kg | Standard Deviation 5.95 |
| Standing and Social Intervention | Change in Leg Strength | Post | 9.15 kg | Standard Deviation 5.25 |
| Control Group | Change in Leg Strength | Pre | 7.87 kg | Standard Deviation 5.42 |
| Control Group | Change in Leg Strength | Post | 7.28 kg | Standard Deviation 4.9 |
Secondary
Change Lower Limb Power
Using the 30second sit-stand test following senior fitness test protocol
Time frame: Pre-Post Testing (following the 5 month intervention)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Change Lower Limb Power | Post | 0.71 Number of repetitions | Standard Deviation 1.81 |
| Standing and Social Intervention | Change Lower Limb Power | Pre | 0.74 Number of repetitions | Standard Deviation 1.84 |
| Control Group | Change Lower Limb Power | Pre | 0.89 Number of repetitions | Standard Deviation 2.34 |
| Control Group | Change Lower Limb Power | Post | 1.1 Number of repetitions | Standard Deviation 2.82 |
Secondary
Depression
Geriatric Depression Scale Short Form (0-15 scale). Lower score is better outcome.
Time frame: Pre-Post Testing (following the 5 month intervention)
Population: Only participants with a MMSE score of 18 or higher were included
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Depression | Pre | 5.1 score on a scale | Standard Deviation 3.2 |
| Standing and Social Intervention | Depression | Post | 5.5 score on a scale | Standard Deviation 4 |
| Control Group | Depression | Pre | 4.9 score on a scale | Standard Deviation 3.5 |
| Control Group | Depression | Post | 4.5 score on a scale | Standard Deviation 2.9 |
Secondary
Fall Efficacy
Falls Efficacy Scale-International Questionnaire (16-64 scale). Low score indicates a better score
Time frame: Pre-Post Testing (following the 5 month intervention)
Population: This was only measured among participants who had a MMSE score of 18 or higher (to ensure they had the cognitive capacity to properly answer the questionnaire)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Fall Efficacy | Pre | 36.7 score on a scale | Standard Deviation 13.2 |
| Standing and Social Intervention | Fall Efficacy | Post | 41.3 score on a scale | Standard Deviation 17.4 |
| Control Group | Fall Efficacy | Pre | 31.0 score on a scale | Standard Deviation 12.8 |
| Control Group | Fall Efficacy | Post | 39.0 score on a scale | Standard Deviation 11.8 |
Secondary
Loneliness
Loneliness was measured using the UCLA Loneliness Scale (20-80). A low score indicates a better outcome
Time frame: Pre-Post Testing (following the 5 month intervention)
Population: Participants only included if MMSE score is equal to or greater than 18.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Loneliness | Pre | 42.3 score on a scale | Standard Deviation 12 |
| Standing and Social Intervention | Loneliness | Post | 38.7 score on a scale | Standard Deviation 12.4 |
| Control Group | Loneliness | Pre | 39.7 score on a scale | Standard Deviation 12.6 |
| Control Group | Loneliness | Post | 33.8 score on a scale | Standard Deviation 11.2 |
Secondary
Metabolic Profile - Blood Glucose
Fasted blood glucose was analyzed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
Time frame: Pre-Post Intervention (before and after 5-month intervention)
Population: Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Metabolic Profile - Blood Glucose | Pre | 5.96 mmol/L | Standard Deviation 2.38 |
| Standing and Social Intervention | Metabolic Profile - Blood Glucose | Post | 6.08 mmol/L | Standard Deviation 2.29 |
| Control Group | Metabolic Profile - Blood Glucose | Pre | 5.43 mmol/L | Standard Deviation 1.95 |
| Control Group | Metabolic Profile - Blood Glucose | Post | 5.47 mmol/L | Standard Deviation 1.77 |
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.
Time frame: Pre and post testing (before and after the 5-month intervention)
Population: Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Metabolic Profile - High Density Lipoprotein Cholesterol | Pre | 1.37 mmol/L | Standard Deviation 1.52 |
| Standing and Social Intervention | Metabolic Profile - High Density Lipoprotein Cholesterol | Post | 1.27 mmol/L | Standard Deviation 0.44 |
| Control Group | Metabolic Profile - High Density Lipoprotein Cholesterol | Pre | 1.33 mmol/L | Standard Deviation 0.51 |
| Control Group | Metabolic Profile - High Density Lipoprotein Cholesterol | Post | 1.17 mmol/L | Standard Deviation 0.57 |
Secondary
Metabolic Profile - Low Density Lipoprotein Cholesterol
Low-density lipoprotein was assessed using a CardioChek Professional Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA).
Time frame: Pre-Post intervention (before and after 5-month intervention)
Population: Research assistants were not able to collect blood data for all participants (due to participant agitation or refusal)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Metabolic Profile - Low Density Lipoprotein Cholesterol | Pre | 2.40 mmol/L | Standard Deviation 1.63 |
| Standing and Social Intervention | Metabolic Profile - Low Density Lipoprotein Cholesterol | Post | 2.19 mmol/L | Standard Deviation 1.21 |
| Control Group | Metabolic Profile - Low Density Lipoprotein Cholesterol | Pre | 2.91 mmol/L | Standard Deviation 1.42 |
| Control Group | Metabolic Profile - Low Density Lipoprotein Cholesterol | Post | 2.72 mmol/L | Standard Deviation 1.56 |
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.
Time frame: Pre-Post Testing (before and following the 5 month intervention).
Population: Blood draws were difficult among this population due to participant agitation, therefore we were not able to collect blood for all participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standing and Social Intervention | Metabolic Profile - Triglycerides | Pre | 1.79 mmol/L | Standard Deviation 1.3 |
| Standing and Social Intervention | Metabolic Profile - Triglycerides | Post | 1.48 mmol/L | Standard Deviation 0.74 |
| Control Group | Metabolic Profile - Triglycerides | Pre | 1.21 mmol/L | Standard Deviation 0.45 |
| Control Group | Metabolic Profile - Triglycerides | Post | 1.47 mmol/L | Standard Deviation 0.82 |
Secondary
Rate of Falls
Falls, injuries due to falls and hospitalization will be collected at 3 timepoints
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.
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
Time frame: Pre-Post Testing (following the 5-month intervention). Data has been collected, but is still being analyzed