Stand if You Can- A Randomized Control Trial
Phase: NA
Conditions: Frailty, Sedentary Behavior, Physical Disability
Sponsor: University of New Brunswick

 
Title: Stand if You Can: A Standing Intervention in Long Term Care 
NCT Number: NCT03796039. 
Version Date: May 1 2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
METHODS 
Study Setting 
The Stand if You Can trial is a multi-center, parallel group, RCT using intention-to-treat 
analysis. For pragmatic reasons, this trial is a single blinded study. It will take place in four 
different LTC facilities within two cities in the Province of New Brunswick, Canada. Two of the 
selected facilities will be in each city. Each facility is designated by the Province of New 
Brunswick as a level three LTC facility (1). This means that the clients have health limitations 
which require assistance and supervision on a 24-hour basis (1,2). Three of the four facilities are 
sister nursing homes, meaning they follow the same policies, similar procedures, and have 
identical floor plans. Registered nurses, licenced practical nurses and rehabilitation assistants are 
regular staff at all the participating homes. Each of the chosen LTC facilities have the space and 
resources necessary to assist in the operation and delivery of the trial.  
Participant timeline 
All of the outcome variables, and participant characteristics will be collected at pre (T1) 
and post (T2) testing. Data regarding fall information will have two additional data collection 
time points, including 6 months prior to the intervention (-T) and 6 months follow-up (T3).  
Attendance will be collected during the intervention, between T1 and T2. See Figure 1 for 
timeline.   
 
Eligibility Criteria 
 
Inclusion criteria:  
1) Participants must be a resident of one of the four participating LTC facilities at the time 
of recruitment. 

 
2) Participants must be able to provide consent or have Substitute Decision Maker agree on 
their behalf to participate in the study if required. 
3) Participants must be able to walk for 10 meters, with or without a walking aid. 
Exclusion Criteria:  
1) Residents identified by the LTC facility’s rehabilitation staff as being too high risk for 
falling, or unable to participate for safety reasons.   
Interventions 
Social Standing Intervention 
Participants residing in one of the facilities randomized to the intervention will be offered 
up to 100 minutes of supervised standing per week, for 22 weeks. To achieve 100 minutes of 
standing each week, participants will stand (either on their own or with a group of their peers) for 
ten minutes at a time, twice per day, five days per week (Monday-Friday). Participants will be 
allowed up to five breaks per session of undefined length to assist in attaining the objective of 
100 minutes of standing per week. During the standing time research assistants (RA) will engage 
socially with the participants, with a 1:4 ratio of RA and participants. If the LTC facility is 
hosting a stationary group activity during the standing time participants will be allowed to 
partake, provided they can do so while standing. If a participant is able, they will be allowed to 
stand for 20 consecutive minutes by week 11 and onward, as opposed to two separates 10-minute 
sessions. The opportunity to have two separate sessions will still be an option for those who do 
not wish to stand for 20 minutes in one session. A session will be terminated if the maximum 
time is reached, if the participant takes all five permitted breaks, or if the participant requests to 
stop or shows signs of physiological distress. Participants will be encouraged to stand five days 
each week. However, if the participant displays strong verbal disinterest, refuses participation, is 

 
non-compliant, or is physically unable to attend, they will be allowed to miss the planned 
session. Participants will not be excluded from the study or subsequent analyses due to non-
compliance to the intervention. Following a request from a consenting participant, LTC facility 
staff, or the Substitute Decision Maker will a participant no longer be asked to participate in the 
standing sessions. Adherence to the intervention will be monitored and tracked using a daily log. 
Participant attendance, total standing time, number of breaks taken, and total group size (if 
applicable) will be recorded at each session. These logs will be kept at the local research 
institution and brought to the LTC facility by RAs each day.  
Social Exposure (control) 
Participants residing in the control facilities will spend 20 consecutive minutes engaging 
in social activities with the RA. Social activities will be structured similarly to the intervention 
group. Some examples include sharing jokes and stories, playing charades, and signing along to 
music.   Social activities will be completed in groups or individually, with participants allowed to 
join the activity by whatever means of transportation they chose. There will be no limit to the 
number of participants allowed to attend each group social activity session, with the number of 
staff ranging from one to two. Adherence to the social activity will be monitored and tracked 
using a daily log noting attendance, total group size (if applicable), the length of the activity. 
These logs will be kept at the local research institution and brought to the LTC facility by RAs 
each day.  
Variables and Measures 
Participant Characteristics 

 
Participant age, sex, height, weight, medical condition, length of stay in the LTC facility, 
transfer status, and frailty status will be collected from LTC staff at pre-testing (T1) and post-
testing (T2) using the most recent data from participants’ LTC health records.  
Primary outcome 
The primary outcome of this study is gait speed. To measure gait speed, participants will 
perform a 10-meter walk at pre and post testing, with the first and last two meters used as 
acceleration and deceleration zones. Gait speed will be measured over the intermediate 6 meters. 
If required, participants will be permitted to use an assistive device while closely monitored by 
RA with an available wheelchair made available for safety. Participants will be instructed to 
walk at a comfortable speed and to start walking when signalled. Using a stopwatch, a RA will 
manually start timing the participant once the participant’s foot or walking aids crosses the 2-
meter mark, whichever occurs first. The timer will be stopped once the participant or the walking 
aid reaches the 8-meter mark and the total time will be recorded in seconds. Once a participant 
completes the first trial, the participants will take a brief pause and a second trial will be 
completed. The average of the two values will be used for analysis.  
 
Secondary Outcomes 
Physical activity and sedentary behavior will be tracked for seven consecutive days at pre 
and post testing using an activPAL (PAL Technologies LTD., Scotland, UK). The activPAL will 
be placed mid-thigh and held in place using TegadermTM tape. Participant sedentary time, 
upright time, stepping time, total number of steps and total transitions from sitting to standing 
will be recorded. ActivPAL data will be considered valid if the participant wears the device over 
at least four consecutive days(3).   

 
 
Leg power will be assessed using the 30-Second Chair Stand at pre and post testing, 
following the Senior Fitness Test protocol (4).  Participants will be seated in a standardized, 
armless chair with their arms crossed across their chest. The participant will stand completely 
and return to a seated position as many times as possible in 30 seconds.  RAs will provide 
guidance as needed during the test for those with cognitive impairments. If participants are 
unable to complete the test following protocol, their score will be recorded as 0.   
Isometric lower leg strength will be assessed using a handheld dynamometer (Lafayette 
Hand-Held Dynamometer, Lafayette Instrument, Sagamore, USA) at pre and post. The 
dynamometer will be positioned mid-tibia, with the padding snug against the participant’s leg. 
To ensure each participant experiences the same resistance throughout the test, RA will use a 
non-elastic woven strap that will interlace around the handle of the dynamometry and chair leg. 
With arms crossed across their chest, participants will then be instructed to extend their leg as 
forcefully as possible into the dynamometer for 10 seconds, with peak strength recorded as 
maximal kilograms (kg) achieved. Leg strength will be assessed twice on each leg, with an 
additional trial if the first two differ by more than one kg. RA will provide motivational cues and 
encouragement during each test.   
Balance will be assessed using the BrainBlox software (5)on a Wii Balance Board 
(Nintendo, Kyoto, Japan) at pre and post testing. The balance board measures ground reaction 
forces that are then computed into centre of pressure measures. Participants will conduct three 
trials of 30 seconds with eyes open. Participants will stand in a neutral position, feet hip-width 
distance apart with their arms at their sides. The balance assessment will be conducted three 
times, with intermittent breaks as needed. If required, participants will be permitted to use an 
assistive standing device.  

 
Metabolic profile will be assessed as participant high-density lipoprotein, low-density 
lipoprotein, total cholesterol, triglyceride, and blood glucose using a CardioChek Professional 
Analyzer system (PTS Diagnostics, Whitestown, Indiana, USA). Following a finger prick 
conducted using a single use lancet, approximately 60 µL of whole blood will be collected. Forty 
µL will be used to assess blood lipids via a Lipid Panel (PTS Diagnostics, Whitestown, Indiana, 
USA), with the remaining 20 µL used to assess blood glucose via a Glucose Panel (PTS 
Diagnostics, Whitestown, Indiana, USA).  
Cognition will be assessed using the Mini-Mental State Examination (MMSE) 
questionnaire(6). Participants who score 18 or above will be asked to complete subsequent 
questionnaires pertaining to their psychosocial health. These questionnaires include the Geriatric 
Anxiety Inventory(7), Falls Efficacy Scale – International (FES-I) (8), Geriatric Depression 
Scale Short Form (9), the DeJong Loneliness Scale (10) and the UCLA Loneliness Scale (11).  
Falls, injuries due to falls, and hospitalization will be collected from the participants 
accident report provided by the LTC facility.  At 6 months follow-up, data will be collected 
retrospectively from 6 months prior to the intervention and up until the 6-month follow up. This 
data includes the number of falls, type and number of injuries as well as the number of hospital 
visits.   
Attendance will be collected throughout the intervention. The daily total standing time, 
number of breaks, the use of an assistive the device as well as the group size will be recorded.   
 
Sample Size 
Sample size was estimated based on anticipated changes in gait speed, the primary 
outcome of this trial. The minimum clinically important difference in gait speed is 0.1 m/sec 

 
(18). With a cluster size of two, and assuming a small-to-moderate clustering effect (intraclass 
correlation coefficient = 0.075), within-group standard deviation of 0.10 m/s, and alpha = 0.05, 
recruiting 36 participants per group will provide 80% power to detect a clinically important 
change in gait speed. To account for an expected loss to follow-up of 20%, we plan to recruit 44 
participants per group (total n=88).  
 
Recruitment  
             The Director of Care for each of the LTC facilities will be contacted to aid in the 
identification of residents who may benefit most from a low-intensity physical activity 
intervention. A letter will be sent from the LTC facility on behalf of the research team to each 
potential resident, or their Substitute Decision Maker to inform them of the study. Once the 
letters are distributed members of the research team will contact residents or their power of 
attorney to formally inquire about participation and obtain informed consent for participation.   
 
Allocation  
RAs not participating in the trial procedures will use a random number generator to 
construct a permuted-block randomisation list (block size = 2). All participants will be cluster-
randomized to the intervention or control group on a 1:1 basis. Group assignments will be 
concealed from participants, outcome assessors, and research staff completing the data analyses. 
RA’s conducting pre-testing evaluations will be blinded at pre-testing, but will conduct post 
testing evaluations unblinded, due the diversity of evaluations requiring training and experience. 
 
Data Management 

 
Each participant will be assigned an ID number. All the data collected will be recorded 
under this number in their participant file. Each file will have the data manually written, and then 
transferred from the files into an excel on password protected computers. The data will be 
entered and revised by two different RAs to reduce potential data entry errors. Only researchers 
engaged in collection, analysis and dissemination will have access to data, with approval of the 
primary investigators. Hard copies of the collected data will be stored in filing cabinets, in a 
locked working space at each university. Data will be kept for a period of seven years, at which 
point it will be destroyed. 
 
Statistical Analysis  
As this is an intention to treat trial, all data will be evaluated based on the randomized 
group allocation. Generalized linear models – specifically an ANOVA analysis, will be used to 
compare the dependant variable (gait speed) between intervention groups while accounting for 
potential confounders (e.g., age, sedentary level).  Secondary outcomes such as sedentary 
behaviour, leg strength, sit to stand ability, balance performance, psychosocial outcomes, and 
blood lipids and blood glucose will each be analyzed with separate linear models as well, in 
relation to intervention group. Consistent with an intention-to-treat approach, the models will 
estimate missing values. When possible, general linear models will also be used to evaluate 
subgroup analyses, where health conditions will be considered a fixed variable in relation to gait 
speed performance. 
 
 
 
 

 
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