Trial Outcomes & Findings for Stand if You Can: A Standing Intervention in Long Term Care (NCT NCT03796039)

NCT ID: NCT03796039

Last Updated: 2023-06-27

Results Overview

Measured by the 10m walking speed test

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 97 participants
• Primary outcome timeframe: Pre and post intervention testing
• Results posted on: 2023-06-27

Participant Flow

Participant milestones

Measure	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	Control Group Control group will receive social visits, but no exposure to standing
Overall Study STARTED	50	47
Overall Study COMPLETED	41	42
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Measure	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	Control Group Control group will receive social visits, but no exposure to standing
Overall Study Death	2	1
Overall Study Withdrawal by Subject	7	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standing and Social Intervention n=50 Participants 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	Control Group n=47 Participants Control group will receive social visits, but no exposure to standing	Total n=97 Participants Total of all reporting groups
Age, Continuous	87.14 years STANDARD_DEVIATION 8.46 • n=50 Participants	85.11 years STANDARD_DEVIATION 7.63 • n=47 Participants	86 years STANDARD_DEVIATION 8 • n=97 Participants
Sex: Female, Male Female	37 Participants n=50 Participants	31 Participants n=47 Participants	68 Participants n=97 Participants
Sex: Female, Male Male	13 Participants n=50 Participants	16 Participants n=47 Participants	29 Participants n=97 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	26.93 kg/m2 STANDARD_DEVIATION 6.53 • n=50 Participants	25.56 kg/m2 STANDARD_DEVIATION 9.01 • n=47 Participants	26.2 kg/m2 STANDARD_DEVIATION 7.8 • n=97 Participants
Frailty	6 units on a scale STANDARD_DEVIATION 1.5 • n=50 Participants	6.13 units on a scale STANDARD_DEVIATION 0.8 • n=47 Participants	6.1 units on a scale STANDARD_DEVIATION 1.2 • n=97 Participants
Transfer Status (Independent Transfer)	8 Participants n=50 Participants	25 Participants n=47 Participants	33 Participants n=97 Participants
Length of stay in LTC	4.6 years STANDARD_DEVIATION 5.4 • n=50 Participants	3.9 years STANDARD_DEVIATION 3.5 • n=47 Participants	4.2 years STANDARD_DEVIATION 4.5 • n=97 Participants
Cognition (MMSE)	15.76 units on a scale STANDARD_DEVIATION 9.2 • n=50 Participants	17.7 units on a scale STANDARD_DEVIATION 8.8 • n=47 Participants	16.7 units on a scale STANDARD_DEVIATION 9.0 • n=97 Participants

PRIMARY outcome

Timeframe: Pre and post intervention testing

Measured by the 10m walking speed test

Outcome measures

Measure	Standing and Social Intervention n=50 Participants 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	Control Group n=47 Participants Control group will receive social visits, but no exposure to standing
Changes in Walking Speed Pre	0.34 m/s Standard Deviation 0.17	0.43 m/s Standard Deviation 0.20
Changes in Walking Speed Post	0.35 m/s Standard Deviation 0.20	0.40 m/s Standard Deviation 0.20

SECONDARY outcome

Timeframe: 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 .

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Pre-Post Testing (following the 5 month intervention)

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

Outcome measures

Measure	Standing and Social Intervention n=50 Participants 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	Control Group n=47 Participants Control group will receive social visits, but no exposure to standing
Change in Leg Strength Pre	9.48 kg Standard Deviation 5.95	7.87 kg Standard Deviation 5.42
Change in Leg Strength Post	9.15 kg Standard Deviation 5.25	7.28 kg Standard Deviation 4.90

SECONDARY outcome

Timeframe: Pre-Post Testing (following the 5 month intervention)

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

Outcome measures

Measure	Standing and Social Intervention n=50 Participants 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	Control Group n=47 Participants Control group will receive social visits, but no exposure to standing
Change Lower Limb Power Pre	0.74 Number of repetitions Standard Deviation 1.84	0.89 Number of repetitions Standard Deviation 2.34
Change Lower Limb Power Post	0.71 Number of repetitions Standard Deviation 1.81	1.1 Number of repetitions Standard Deviation 2.82

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Measure	Standing and Social Intervention n=20 Participants 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	Control Group n=25 Participants Control group will receive social visits, but no exposure to standing
Change in Anxiety Symptoms Pre	6.1 units on a scale Standard Deviation 7.2	6.6 units on a scale Standard Deviation 6.0
Change in Anxiety Symptoms Post	6.7 units on a scale Standard Deviation 7.1	6.6 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Pre-Post Testing (following the 5 month intervention)

Population: Only participants with a MMSE score of 18 or higher were included

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

Outcome measures

Measure	Standing and Social Intervention n=20 Participants 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	Control Group n=25 Participants Control group will receive social visits, but no exposure to standing
Depression Pre	5.1 score on a scale Standard Deviation 3.2	4.9 score on a scale Standard Deviation 3.5
Depression Post	5.5 score on a scale Standard Deviation 4.0	4.5 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Pre-Post Testing (following the 5 month intervention)

Population: Participants only included if MMSE score is equal to or greater than 18.

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

Outcome measures

Measure	Standing and Social Intervention n=20 Participants 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	Control Group n=25 Participants Control group will receive social visits, but no exposure to standing
Loneliness Pre	42.3 score on a scale Standard Deviation 12.0	39.7 score on a scale Standard Deviation 12.6
Loneliness Post	38.7 score on a scale Standard Deviation 12.4	33.8 score on a scale Standard Deviation 11.2

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Measure	Standing and Social Intervention n=20 Participants 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	Control Group n=25 Participants Control group will receive social visits, but no exposure to standing
Fall Efficacy Pre	36.7 score on a scale Standard Deviation 13.2	31.0 score on a scale Standard Deviation 12.8
Fall Efficacy Post	41.3 score on a scale Standard Deviation 17.4	39.0 score on a scale Standard Deviation 11.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Standing and Social Intervention n=32 Participants 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	Control Group n=38 Participants Control group will receive social visits, but no exposure to standing
Metabolic Profile - Triglycerides Pre	1.79 mmol/L Standard Deviation 1.30	1.21 mmol/L Standard Deviation 0.45
Metabolic Profile - Triglycerides Post	1.48 mmol/L Standard Deviation 0.74	1.47 mmol/L Standard Deviation 0.82

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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)

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.

Outcome measures

Measure	Standing and Social Intervention n=32 Participants 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	Control Group n=38 Participants Control group will receive social visits, but no exposure to standing
Metabolic Profile - High Density Lipoprotein Cholesterol Pre	1.37 mmol/L Standard Deviation 1.52	1.33 mmol/L Standard Deviation 0.51
Metabolic Profile - High Density Lipoprotein Cholesterol Post	1.27 mmol/L Standard Deviation 0.44	1.17 mmol/L Standard Deviation 0.57

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Measure	Standing and Social Intervention n=32 Participants 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	Control Group n=38 Participants Control group will receive social visits, but no exposure to standing
Metabolic Profile - Low Density Lipoprotein Cholesterol Pre	2.40 mmol/L Standard Deviation 1.63	2.91 mmol/L Standard Deviation 1.42
Metabolic Profile - Low Density Lipoprotein Cholesterol Post	2.19 mmol/L Standard Deviation 1.21	2.72 mmol/L Standard Deviation 1.56

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Measure	Standing and Social Intervention n=32 Participants 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	Control Group n=38 Participants Control group will receive social visits, but no exposure to standing
Metabolic Profile - Blood Glucose Pre	5.96 mmol/L Standard Deviation 2.38	5.43 mmol/L Standard Deviation 1.95
Metabolic Profile - Blood Glucose Post	6.08 mmol/L Standard Deviation 2.29	5.47 mmol/L Standard Deviation 1.77

Adverse Events

Standing and Social Intervention

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Standing and Social Intervention n=50 participants at risk 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	Control Group n=47 participants at risk Control group will receive social visits, but no exposure to standing
Injury, poisoning and procedural complications Fall	2.0% 1/50 • Number of events 1 • During trial (5 months)	0.00% 0/47 • During trial (5 months)

Additional Information

Dr. Danielle Bouchard

University of New Brunswick

Phone: (506) 443-3908

Email: dboucha1@unb.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place