A Model for Delivering Strength Training and Nutrition Education for Older Adults (MoveStrong): A Pilot Randomized Controlled Trial
Phase: NA
Conditions: Chronic Disease, Frail, Diabetes Mellitus, Cancer, Chronic Lung Disease, Cardiovascular Diseases, Congestive Heart Failure, Hypertension, Osteoporosis, Osteopenia, Arthritis, Stroke, Kidney Diseases
Sponsor: University of Waterloo

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Official Title: Strength training and nutrition education for older adults 
(MoveStrong): A pilot randomized controlled trial 
 
NCT Number:  
 
Date of the Document: July 18, 2019  
 
 
 
 

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History of Changes 
 
July 12, 2019: Stair climb test was removed since not all sites had stairs.  
July 14, 2019: Replaces the CHAMPS questionnaire with the Physical Activity Scale. 
July 18, 2019: Minor editorial changes. 
 

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ABSTRACT 
 
Background: Age-related loss of muscle mass and strength can lead to disability, frailty, and health 
instability. There is strong evidence certain types of exercise can prevent falls, disability, and bone 
loss but many older adults do not meet the physical activity guidelines. The purpose of this study 
will be to assess the feasibility of implementing workshops to teach functional strength and balance 
training and nutrition to older adults (MoveStrong) across diverse settings. 
Design: This is a closed cohort stepped wedge design. 
Setting: Northern (rural) and Southern Ontario sites in Canada 
Participants: We will recruit 40 older adults considered pre-frail as measured by the FRAIL Scale, 
≥60 years old, with at least one chronic condition, but who are currently not engaging in a regular 
exercise program. 
Intervention: The MoveStrong program is an eight-week exercise and nutrition program. The 
program will include a kinesiologist-led twice-weekly functional strength and balance program, and 
two seminars delivered by a dietian on behavior change strategies to promote healthy eating and 
specifically increase protein intake. 
Measurements: The primary outcome is feasibility of implementation, defined by recruitment, 
retention, and adherence rates. Secondary outcomes include frailty indicators, mobility and balance 
measures, quality of life, dietary protein intake, adverse events, and participant and provider 
experience. We will analyse feasibility objectives using descriptive statistics based on estimates 
with 95% confidence intervals. Secondary outcomes will be evaluated in exploratory intention-to-
treat and per protocol analyses via independent Student t tests or logistic regression. Content 
analysis will be used to identify facilitators or barriers to implementation.  
Conclusions: Our goal is to develop a scalable model for enabling older adults to participate in 
functional strength and balance training, and to consume adequate protein. The current study will 
inform the feasibility of a larger pragmatic trial in other diverse settings. 
 

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INTRODUCTION 
With age, there are a number of changes in body composition including atrophy of the 
skeletal muscle, beginning around age 25 and accelerating after the age of 50 (1,2). Sufficient 
muscle strength is necessary to provide a reservoir of protein for the immune system, prevent falls 
and disability, and perform activities of daily living such as getting up from the bed. When age-
related loss of muscle mass decreases beyond a defined threshold, this is termed sarcopenia (1). The 
European Working Group on Sarcopenia in Older People is one of several groups that has provided 
a working definition of sarcopenia as “a progressive loss of skeletal mass and strength that increases 
the risk of adverse outcomes such as physical disability, poor quality of life, and frailty” (3). The 
physical features of frailty include weakness, slowness, unintended weight loss, and low physical 
activity (4). Between 1 to 29% of community-dwelling older adults have sarcopenia, and this has 
direct consequences on personal, social, and healthcare costs, which will rise steadily with an 
increasing ageing population (1,5). 
There is evidence that regular exercise [i.e., planned, structured, and repetitive bodily 
movement done to improve or maintain one or more components of physical fitness (6)] can 
improve muscle outcomes in older adults (5,7–9), and there is emerging data for significant 
psychological and cognitive benefits accrued from regular exercise (9). A narrative review, based on 
multiple meta-analyses, suggests exercise training improves functional capacity and muscle strength 
in individuals with different chronic diseases without having a negative effect on disease 
progression (10). These results are corroborated in a recent meta-analysis that reported exercise 
interventions significantly improve some, but not all, aspects of muscle strength and mass, and 
functional outcomes in older adults with sarcopenia (11). Specifically, resistance training alone, 
performed between 3 to 18 months, improved muscle mass and strength, and physical performance 

5 
 
variables, such as chair rise, stair climb, and the 12-minute-walk-test in older adults with sarcopenia 
(5). Similarly, progressive resistance training performed two to three times per week at a high 
intensity result in moderate to large significant improvements in gait speed, getting out of a chair, 
and muscle strength (12). Further, a recent Cochrane review reported that balance and functional 
exercises reduced the rate of falls by 24% in community dwelling older adults (13), and balance and 
functional exercises in combination with resistance training could potentially reduce the rate of falls 
by more than 30% (13). 
The benefits accrued from exercise are evident, but over 75% of Canadian adults 18 years 
and older are not meeting the physical activity guidelines, and it gets worse with age, as 88% of 
adults over 65 years of age do not meet exercise guidelines (14). Thus, the biggest challenge is not a 
lack of evidence that exercise is beneficial, but the absence of effective, sustainable real-world 
implementation exercise models, especially for older adults with chronic conditions. In our previous 
work, we tested a model for delivering balance training for adults ≥75 years old in primary care who 
were not physically active (a 1:1 session followed by 4 group sessions) (15). We defined physical 
inactivity as individuals who are physically active occasionally or during certain seasons more than 
others or as not physically active beyond moving around or walking during activities of daily living 
(15). In exit interviews, participants stated they valued a familiar location (e.g., a doctor’s office), 
small group classes, personal attention, social interaction, learning from others, free or low-cost 
classes, easy-to-read materials, and encouragement to attend with a caregiver/friend for social or 
physical support. Using what we learned, we collaborated with the YMCA, Community Support 
Connections, Osteoporosis Canada, and patient advocates to co-create MoveStrong – a model of 
service delivery that adapts functional strength training (e.g., squats, push-ups, step-ups, loaded 
carries) to support movements performed during activities of daily living. The MoveStrong model is 

6 
 
designed to be scalable in multiple settings, with training materials for instructors to tailor, teach, 
and progress functional moderate-high intensity strength and balance training. There are variations 
of each movement on a continuum from seated exercises to body weight exercises to more 
challenging versions with weights. The program uses fundamental strength training exercises 
aligned with functional movements to promote personal relevance; for example, step-ups build stair-
climbing power while loaded carry exercises may translate to transporting groceries more 
efficiently. Balance challenges are included for fall prevention (16,17). MoveStrong also provides 
two dietian-led seminars and a booklet focused on using real food to improve protein intake. From 
past work, we identified meal preparation approaches with fresh ingredients are preferred over 
supplements. 
Objectives  
We aim to lead a pragmatic trial where settings (retirement homes, YMCAs, family health 
teams) are cluster randomized to timing of the MoveStrong implementation to evaluate the Reach, 
Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM Framework) (18), including 
cost-effectiveness and sustainability. The pilot study will assess the feasibility, fidelity and 
adaptability of the MoveStrong model in diverse settings and responsiveness of outcomes. The 
primary objectives of the proposed pilot study will be to: 
1. Evaluate the number of participants recruited to participate at the start of the study;  
2. Determine retention rates at the end of the study; and 
3. Calculate adherence rates to the MoveStrong program. 
Secondary objectives will determine participants’ and providers’ experience with MoveStrong, 
adaptations to the model, the cost relative to the benefit, the short-term responsiveness of frailty 

7 
 
indicators, protein intake, quality of life, and if the exercise and changes in eating behaviour are 
maintained.  
 
METHODS 
The protocol was drafted in accordance with the SPIRIT 2013 checklist of information to 
include when reporting a pilot or feasibility trial (https://www.spirit-statement.org/). In addition, we 
followed the TIDieR checklist for describing interventions in sufficient detail to allow their 
replication (http://www.equator-network.org/wp-content/uploads/2014/03/TIDieR-Checklist-
PDF.pdf).  
 
Trial design 
This is a pilot single-blinded multicentre RCT to determine the feasibility of implementing a 
twice-weekly exercise program with a nutritional component for 8 weeks. We will use a closed 
cohort stepped wedge design at four sites across Ontario. At regular intervals (the “steps”) one 
cluster (i.e., one site) is randomized to cross from the control to the intervention (see Figure 1) (19). 
This process continues until all clusters have crossed over to the intervention and at the end of the 
study all clusters will have received the MoveStrong program. 
 
Study Setting 
One Northern and three Southern Ontario sites were chosen to ensure diversity in city 
population, structure, services, and other variables. Participants will be recruited from local primary 
care practices, retirement homes and via advertisement. We will evaluate the MoveStrong program at 
three distinct settings; retirement home, YMCA, and a family health team. The MoveStrong program 
will be implemented and delivered at a kinesiologist-led clinic partnered with the City of Lakes 

8 
 
Family Health Team (Sudbury), Arbour Trails Retirement & Independent Living (Guelph), Village 
of Winston Park (retirement home & independent living, Kitchener), and two of the YMCA’s of 
Cambridge and Kitchener-Waterloo (CKW YMCA, each YMCA is part of one cluster). The Sudbury 
site is located in Northern Ontario, while the others are in Southern Ontario. Data collection will occur 
at these four sites. The University of Waterloo will be the coordinating site. The Sudbury 
implementation site will have a kinesiologist led clinic (Kinnect to Wellness) partnered with a family 
health team. 
 
Eligibility Criteria 
Residents are eligible to participate in the study if they: speak English or attend with a 
translator; ≥ 60 years; have a FRAIL Scale score ≥1; and have ≥1 primary care diagnosed chronic 
condition [e.g., diabetes, obesity, cancer (other than minor skin cancer), chronic lung disease, 
cardiovascular disease, congestive heart failure, hypertension, osteoporosis, arthritis, stroke, or 
kidney disease]. Participants will be encouraged to attend with a caregiver/friend for social or 
physical support, and the caregiver/friend can choose to complete the screening and assessment 
process if eligible. Residents cannot participate in the study if they: are currently doing similar 
resistance exercise ≥2x/week; are receiving palliative care; cannot perform basic activities of daily 
living; have severe cognitive impairment (e.g., unable to follow two-step commands); travelling >1 
week during the MoveStrong program; and have absolute exercise contraindications. Absolute 
exercise contraindication will be assessed using the Get Active Questionnaire, and if a participant 
selects “YES” to any question on this questionnaire, they must seek physician approval before 
exercising. 
 

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Intervention 
The MoveStrong program has two main components, an exercise program and nutrition 
education. 
Exercise (functional strength and balance training): MoveStrong is designed to provide a scalable 
framework for exercise professionals to tailor fundamental strength training exercises for older 
adults of varying abilities, using minimal equipment. The exercises are aligned with functional 
movements to promote personal relevance; jump, step-ups, reach, squat, pull, lift and carry, and 
push. The MoveStrong framework guides exercise selection, prescription details (e.g., intensity, 
volume, time under tension) and progression (Table 1). Seated exercises are provided only for 
participants who cannot perform the lowest level of difficulty (Level 1) with or without external 
support (e.g., walker, cane, wall, table). Exercises are informed by the GLAD program for arthritis 
(20), BoneFitTM (21), and meta-analyses on resistance exercise and fall prevention (8,12,16,17,22) 
that emphasize functional strength and balance exercise. Each participant will have a 1:1 session 
with a kinesiologist who will select a starting level and variations for each functional movement, 
intensity, and the number of repetitions and sets. Then, participants will attend a kinesiologist-led 
exercise workshop (5 attendees, 1:5 kinesiologist to participant ratio) twice a week for 8 weeks. 
Each site will receive a standardized toolkit with materials for participant workbooks and a trainer 
manual. The manual provides guidance on how to deliver the workshop, select and progress 
exercises, adapt exercises for common impairments, cueing tips, and discussion topics. Participant 
workbooks will be assembled to include pictures of each exercise (i.e., the variation of each 
movement selected for them) with instructions so they can take home to practice and exercise logs 
and planning worksheets. For the pilot study, we will run four workshops a week to accommodate 
ten participants. The exercise program starts with a warm up (5-7 minutes) that include a reactive 

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stepping game (http://clockyourself.com.au) or other balance and agility activities. Participants then 
complete the MoveStrong exercises in a circuit (jump, step-ups, reach, squat, pull, lift and carry, and 
push) where they perform 2-3 sets of 3-8 repetitions of each exercise with time under tension per 
repetition of 2:0:4 seconds for concentric:rest:eccentric). During the first week, the focus is on form 
rather than intensity. Exercise difficulty, resistance used, or volume (up to 3 sets, up to 8 reps) is 
progressed over time, with a target intensity of < 8 repetitions maximum (RM). At the end of each 
workshop session is a 10-minute group discussion where participants select an “Exercise of the 
Week” to plan when and where to practice it at home, or in a setting of choice. Schlegel Villages 
will provide kinesiologists for the Guelph and Kitchener sites and we will contract independent 
kinesiologists for the CKW YMCA and Sudbury sites to deliver the intervention (not blind to 
cluster allocation). 
Nutrition Education: Participants receive an education booklet and participate in two dietitian-led 
group seminars that discuss strategies to increase protein intake. Presentations topics will consider 
the cost of preparing high protein foods and the ability of retirement home residents to alter their 
diet when food is provided, guide how and why to spread protein intake through the day, how much 
protein is in their usual diet, low cost options, easy-to-consume protein-rich snacks with minimal 
preparation, high quality protein supplements (e.g., rapidly digested, high leucine like whey), and 
how to prioritize high-protein choices in retirement home menus or restaurants. Other activities 
include sampling of protein-rich snacks. Seminars will occur at weeks 2 and 5 to allow time in 
between to review material and revisit topics and address questions. We will promote a protein 
intake greater than 1.2 g/kgBW/day, 20-30g/meal. In the pilot study, two sites will have sessions led 
by an in-person dietian and the other two sites will be led online by a dietian to assess the challenges 
and successes of an in-person versus virtual strategy. The dietitian is not blind to cluster allocation. 

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Recruitment 
We will send posters and referral forms to local primary care providers, retirement homes, 
and fracture clinics for recruitment. We will also use social media (Facebook and Twitter) to 
advertise the MoveStrong study and share our recruitment posters with local contacts.  
 
Data Collection Methods 
A research assistant from the University of Waterloo and two nurses from the Sudbury site 
(all blinded to allocation) will recruit participants and collect data. They will record the number of 
eligible participants, the number of individuals willing to be randomized in the study, and retention 
rates; these rates will be reported in a standard excel sheet. An independent biostatistician will then 
develop a computer-generated randomization sequence at St. Joseph’s Healthcare in Hamilton and 
randomize sites to implement MoveStrong at one of four start times, each three weeks apart. The 
randomization sequence will be maintained and concealed by a co-investigator at a site independent 
from those recruiting participants or delivering the intervention. The co-investigator will 
communicate allocation to a researcher or clinician at the central site who is not blind to group 
allocation at the end of pre-rollout. Clusters one and three will receive the nutrition education 
sessions in person, and clusters two and four will receive skype-led sessions.  
The kinesiologist at each site will use a standardized calendar to record adherence rates. 
After the participant provides written informed consent (Appendix B), a research assistant will 
complete all baseline assessments. We aim to recruit all participants prior to randomizing sites to 
MoveStrong program start time. The same research assistant will conduct an additional three 
assessments each six weeks apart. Questionnaires may be conducted over the phone, if it is not 
possible to complete them in a visit. We will record and report any assessor that is unblinded as part 
of the feasibility evaluation.   

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Data Management 
 
Each recruiting site will be required to keep accurate and verifiable source notes relevant to 
each study participant, and a protocol deviation log. Participants will be de-identified by assigning 
an ID to be used on all forms and in the data management spreadsheet. Identifiable information (i.e., 
full name, date of birth, site number, and contact details) from the southern Ontario sites will be 
kept in a locked cabinet at the University of Waterloo. Records at the Sudbury site will be stored in 
a password protected electronic medical record located at the City of Lakes Family Health Team. 
Only the principal investigator and nurses in the Sudbury location will be able to view both the 
participants’ data and identifiers’ spreadsheet. When the research trial is complete, it is a 
requirement of the Research Governance Framework and Sponsor Policy that the records are kept 
for 20 years. 
 
Outcomes 
Primary outcome: The primary research question is feasibility of implementation, defined by 
recruitment (number of participants recruited at the end of rollout), retention (number retained at 
post-rollout end), and adherence (percentage of exercise sessions completed). Our criteria for 
success are to recruit 10 participants at each of the four sites (40 total), retention of 90% at post-
rollout end, and adherence of ≥70% (15,23). 
 
Secondary outcomes: We will measure the following secondary outcomes: frailty indicators, 
quality of life and resource use, dietary protein intake, participant and provider experience, adverse 
events, and whether behaviour change was maintained (see Table 4 for a timeline). 
 

13 
 
Frailty indicators: Fried Frailty Index components will be used to guide selection of frailty 
indicators (24). We will measure change in body weight with a calibrated scale, walking speed via 
the 10-metre walk test (25), fatigue with the Center for Epidemiologic Studies Depression Scale-
fatigue questions (26), and physical activity levels using the Physical Activity Scale (PAS) 
previously developed by our lab. To assess handgrip strength, we will follow the 2016 National 
Institute for Health Research (NIHR) Southampton protocol and use a digital Jamar Hand 
Dynamometer to measure isometric grip force in the non-dominant hand (27,28). To assess lower 
body strength and dynamic balance we will use a number of standardized tests including the 30 
Second Chair Stand Test and the Four Square Step Test (29). To test leg strength and endurance, we 
will use the 30-second chair stand test that requires a chair with a straight back against a wall, 17 
inch high, without armrests and rubber tips on the legs (30). Participants will be asked to sit in the 
middle of the chair, place their hands on the opposite shoulder crossed at the wrist, feet flat on the 
floor with a straight back (30). When the research assistant says, “go”, the participant will rise to a 
full standing position and then sit back down again as quickly as possible for 30 seconds (30). Foot 
clearance is an important function in everyday life and the ability to accomplish this in different 
directions is essential when reacting to stimuli in the real world (i.e., navigating a busy street or 
walking on uneven pavement) (31). The Four Square Step Test incorporates rapid stepping whilst 
changing direction; a square is formed using four 90 cm long canes resting flat on the floor and the 
participant will step in each square as fast as possible (32). Each square is labelled 1 to 4. The 
participant will start in square 1 facing square 2 and then step forward into square 2, sideway to 
square 3, backward to square 4, sideway to square 1, sideway to square 4, forward to square 3, 
sideway to square 2, and backward to square 1 (32).   
 

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Quality of life and resource use: The EuroQol Group 5 Dimension 5 Level (EQ-5D 5L) 
questionnaire is a multi-attribute health related quality of life tool that we will use to achieve a 
quality-adjusted life year (QALY) estimate per intervention (33). We will use a questionnaire, 
developed by our team in conjunction with health economic experts from the University of Toronto, 
to assess healthcare resources, including direct medical (e.g., personnel, hospitalization, 
medications, rehabilitation, tests), direct non-medical (e.g., out of pocket expenses, transportation), 
and indirect resources (e.g., Productivity and Activity Index), used over the last 6 weeks. 
Multiplying resources collected by jurisdictional unit costs will determine the total cost per exercise 
program. 
 
Dietary energy/protein intake: We will use the Automated Self-Administered 24-Hour (ASA24®) 
Dietary Assessment Tool (epi.grants.cancer.gov/asa24/) to conduct interviewer administered diet 
recalls for 2 weekdays and 1 weekend day. Nutrient analysis is automated and will be used to 
quantify and compare protein and energy intakes at baseline (week 1) and at follow-up (week 36). 
 
Participant and provider experience and satisfaction, adaptations, fidelity: We will use a semi-
structured interview guide to conduct exit interviews with each participant and the kinesiologists 
(see Table 2 for examples). Interviews will be audio-recorded and transcribed verbatim. One 
researcher will perform content analyses to describe participant and provider experience and 
satisfaction, adaptations, and learning needs. Analyses will be verified by another research through 
member checking. Kinesiologists and staff will be given a spreadsheet to record any protocol 
adaptations, challenges and successes to inform a future trial. We will video record sites to observe 
a MoveStrong session and evaluate fidelity via fidelity checklist. 

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Adverse Events: We will ask participants to report adverse events such as falls, fractures, muscle 
pain, etc., using Health Canada definitions (34). Any major adverse events (e.g., fracture, death, 
hospitalization event) will be reported to the principal investigator and to a Data Safety Monitoring 
Committee (DSMC).  
 
Demographic information: Questionnaires will be used to collect demographic data and medical 
history (e.g., co-morbidities). Weight will be measured using a calibrated scale and height will be 
measured via stadiometer or wall mounted measuring tape. 
 
Statistical analyses 
Demographic data and outcomes will be summarized using descriptive measures such as 
mean and standard deviation or mean and confidence intervals for continuous variables, and count 
and percent for categorical variables. Recruitment, retention and adherence will be reported as a 
mean and standard deviation or estimates based on 95% confidence intervals (Table 3). To assess 
responsiveness of frailty indicators, we will calculate standardized response means, or mean change 
in score divided by the standard deviation of the changed scores. We will conduct exploratory 
analyses of secondary outcomes using linear regression, adjusted for period, time by exposure 
interaction and intra-cluster correlation (SASv9.2, North Carolina), and sensitivity analyses 
with/without caregiver or friend participation. Clusters will be analyzed according to their 
randomized exposure, regardless of whether exposure was achieved at the correct time. We will 
compare groups using per protocol analysis and exploratory intention-to-treat analysis and we will 
impute missing data using multiple imputation. The criterion for statistical significance will be set at 
alpha = 0.05. To analyse the exit interviews, we will do thematic analysis to identify positive or 

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negative experiences, and suggested adaptations using NVivo version 12 Pro or higher (QSR 
International Pty Ltd, 2019). Adverse events will be reported with descriptive statistics or estimates 
based on 95% confidence interval.  
 
Sample size 
Although Sim and Lewis recommend at least 50 participants (35) and Julious, 12 per group 
(36), we have selected a recruitment rate of 10 participants at each site because of the proposed class 
ratio of one instructor to five participants. Recruiting 10 participants will allow us to observe 
feasibility of delivery of two full workshops of five people each.  
 
Data Safety Monitoring Committee (DSMC) 
 
A DSMC of three arms’ length members (a physician, a physical therapist and a 
biostatistician) will review adverse events after two clusters have completed half of the program to 
review adverse events and study progress. The DSMC will have unblinded access to all data, will 
report to the primary investigator, and will guide how we might roll participants into a larger trial. 
No interim analyses are planned and there are no stopping guidelines for the pilot trial. 
Ethics and confidentiality 
 
The research will be conducted according to the 2014 Tri-Council Policy Statement, 
(http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/default/). The study has 
received approval from the University of Waterloo Integrated Research Ethics Board. Any future 
amendments will be submitted to the ethics board by the principal investigator and updated in the 
registered clinical trials protocol. 
 

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DISCUSSION 
There is a substantial body of evidence demonstrating that physical activity improves heart 
health, muscle and bone strength, and prevents falls, pain and disability among older adults. The 
MoveStrong trial is a pilot RCT of an exercise and nutrition intervention designed to teach 
functional movements and improve nutrition intake among pre-frail older adults living in the 
community. Given the association between frailty, functional limitations, and nursing home 
admissions, identifying a pragmatic model to teach functional exercises may improve the uptake of 
physical activity and slow the progression of frailty; however, it remains unclear how best to engage 
older adults in community exercise programs. To our knowledge, the MoveStrong trial is the first 
pilot RCT to implement an exercise and nutrition model in alignment with the Strategy for Patient 
Oriented Research. This is important because the design is based on patient-identified priorities, 
which ultimately lead to better patient outcomes. Another unique feature of our program is the 
selected intervention for participants is service provision. It incorporates a delivery model to 
translate exercise evidence that is adaptable and scalable in different community settings (e.g., 
family health team, retirement home, YMCA, community programs, etc) and promotes sufficiently 
dosed functional strength and balance training. We designed the MoveStrong program so it results 
in sustainable behaviour change where people are not dependent on the program in the long-term 
and this may be cost-effective at the healthcare level.  
The HOPE trial was one of the first pilot studies evaluating the effectiveness of a home-
based exercise program in the frail population (37). The authors reported only one-fifth of those 
approached were successfully recruited and their recruitment rates were lower than the majority of 
RCTs but their retention rates were high (92%) with only three of the 84 participants lost to follow-
up (37). Recruiting pre-frail and frail older adults in community based intervention programs is a 

18 
 
complex process and older people may be suspicious of research studies because of feelings of 
vulnerability or prior experiences (38). However, it is important to realize that if someone made an 
informed decision to refuse to participate and was comfortable with that decision, this should not be 
considered as a lack of success (38). To improve our level of recruitment in this population, we have 
adapted some lessons based on prior experience from other researchers: 1) before talking to the 
participant, find out a little about them; 2) offer an accurate, concise explanation and overview of 
the MoveStrong program, and 3) provide the participant enough time to consent. In the HOPE trial, 
adherence was low (mean 46%), although the authors believe the home-based exercise frequency of 
3 times per day for five days over the course of 12 weeks was not realistic for some older adults. For 
our study, we propose an exercise frequency of 2 times per week for 8 weeks, which may be more 
realistic for pre-frail older adults. In addition, our program provides a social network that is 
important for older adults. In a qualitative study of older adults with cardiac events, factors that 
influenced uptake of exercise and short term adherence included social support (e.g., health 
professionals, family, and friends), structured classes (novel exercises, specialist staff, routine, 
purpose), health (belief in health benefits), and high self-efficacy (39). Strategies to increase future 
uptake and adherence included support (a reasonable staff-to-participant ratio and group 
meetings/discussions) and motivation (challenge and variety, goal setting and feedback) (39). The 
MoveStrong program was designed to increase uptake and adherence by providing a 1:5 
kinesiologist to participant ratio and by offering exercises on a continuum to maintain motivation. 
There is a need to continue to develop and refine strategies to increase the uptake of exercise among 
pre-frail and frail older adults, and, accordingly, the proposed study protocol hopes to extend the 
current knowledge in this area by specifically examining the feasibility of the MoveStrong model.   

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The MoveStrong trial has a few strengths. One, it incorporates behavior change techniques, 
such as a kinesiologist led exercise sessions and social engagement, to promote higher uptake and 
adherence. It also uses a eligibility criteria consistent with a pragmatic trial (40) such that we will 
include a wide range of participants to meaningfully assess the feasibility of and implementation for 
our trial. Lastly, the stepped wedge design provides the advantage that all participants will 
eventually receive the intervention making recruitment easier (41). A limitation of our pilot trial is 
the short follow-up period, which prevent us from examining the long-term maintenance of our 
program. The stepped wedge design also has a limitation; for example there is concern that an 
intervention implemented in all clusters has not yet been proven effective (41). However, despite 
this limitation we chose to use a stepped wedge design since there is mounting evidence that 
exercise and good nutrition can improve health outcomes in this population. It can also be argued 
that there are some circumstances where the stepped wedge trial is preferable to the parallel RCT 
(42) since the stepped wedge design is superior both scientifically and ethically as more data can be 
obtained and all groups can receive the intervention.  
In summary, our goal is to implement and evaluate a sustainable and pragmatic model for 
delivering functional strength and balance training and promoting adequate protein intake among 
older adults. Future research can examine whether a model like this could be implemented at scale.  
 
OTHER INFORMATION  
Registration: This trial is registered in ClinicalTrials.gov Identifier NCTO20190401. 
Funding: Funding for this project was provided by The Canadian Institutes of Health Research 
(CIHR-SPOR grant) [CIHR Funding Reference Number SCT-162968]. 
 

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Appendix A 
 
Figure 1: MoveStrong study design and allocation strategy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study 
start-up, 
training 
Pre-
rollout 
period - 
Data cleaning, 
analysis, 
dissemination
Time in 
weeks
1 to 8
9 to 16
17 to 
18
19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
37 to 52
Cluster 1
x
x
x
x
Cluster 2
x
x
x
x
Cluster 3
x
x
x
x
Cluster 4
x
x
x
x
Training of staff, orientation to study and materials
During the pre-rollout period, study sites will initiate advertisement and recruitment. 
Roll-out period: Intervention is rolled out every three weeks
Exposure to MoveSTroNg workshop
Maintenance period: MoveSTroNg workshop is complete. Participants are encouraged to sustain behaviour change
x
Rollout, Exposure and Maintenance 
Repeated measurements from individuals at fixed time points, allowing assessment of period effect

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Table 1: MoveStrong Movements with Progressions  
Warm-up 
Seated Version 
Level 1 
Level 2 
Level 3 
Clock Yourself – 
Balance 
challenge 
activity 
Heel and toe taps to clock 
numbers 
Reactive stepping to numbers 
Increase speed 
 
Add challenge e.g., 
step+bicep curl 
Exercise: 
Functional 
movement 
Seated Version3 
Level 1 
Level 2 
Level 3 
Jump 
 
Heel drops, hops 
Jump squat, foot stomp, low 
drop jump with soft landing 
Progressively higher drop 
jumps 
Step ups 
Weighted1 calf raises 
Weighted1 leg extension  
Low step up 
Weighted1 low step up 
Progressive increase in riser 
height or increased weight 
Increase riser height and 
weight 
Reach 
Resisted1 thoracic extension 
Back to wall shoulder flexion 
Resisted1 cross-body thoracic 
extension 
Thoracic/lumbar extension 
(bird-dog) at wall or counter 
Resisted1 overhead press 
Thoracic/lumbar extension on 
hands/knees (bird-dog)2 
Weighted1 overhead press 
Squat 
Seated press ups, use arms 
Resisted1 leg press 
Sit to stand (can use arms) 
High box1 unassisted sit-stand 
Medium box1 unassisted sit to 
stand 
Low box1 unassisted sit-to-
stand 
Half squat 
Body weight squat 
Weighted1 squat, sit to stand 
or half squat 
Split squat or one-leg squat 
Pull 
Resisted seated row 
Standing resisted row 
Resisted pull apart 
Resisted pull down or pull 
apart 
Increase resistance, bent over 
row  
1-arm resisted/weighted pull 
down or row 
TRX row 
Chin-up 
Hinge 
Hip hinge, perched posture 
with pressure through feet 
Supine glute bridge2 
Standing Wall tap hip hinge 
 
Single leg supine glute 
bridge2 
Standing resistance band hip 
hinge1 
Weighted hip hinge1 
Romanian hip hinge (1 leg, or 
modified golfer’s reach) 
Push 
Resisted1 Chest Press 
Wall push up or plank to push up 
Standing resisted chest press 
Counter/table push up 
Floor push up or plank to 
push up  
Stand tall, carry 
your stuff 
Seated back extension with tall 
posture 
2x10m weighted1 carry, 
“Farmer’s walk” 
Increase distance up to 20m 
Complete 4 x 20m 
Increase weight 
Cool-down 
Seated Version 
Level 1 
Level 2 
Level 3 
1Resisted movements use elastic tubing or bands. Weighted movements use household objects, held close to body e.g., water bottles, 4L jugs of water, weighted grocery bags. 
Ankle/wrist weights can be used if needed e.g., paralysis in one hand/arm. Form and alignment are prioritized over intensity. Participants with access to exercise equipment can 
choose to learn how to practice with that instead e.g., kettle bell. We will purchase boxes of different heights, fitness steps and risers, kettle bells and weighted bars for sites to use 
with participants that progress to weighted exercises. 2We will also include forward and backwards chaining of getting on and off floor if that is participant’s goal, with or without 
chair or support object.  
 

22 
 
Table 2: Interview guide to conduct exit interviews with each participant and the exercise 
professional.  
Predetermined Questions 
Questions for the participant: 
Questions for the kinesiologist: 
Why did you decide to join this study?   
Tell me about your experience delivering the 
MoveStrong program? 
What, if any, benefit are you getting/did you 
get out of your involvement in the study? 
What did you like about the manual? What did 
you dislike about it? 
What did you like about the exercise 
program? 
Which exercises did you find more challenging 
to teach? 
What did you like about the nutrition 
sessions? 
How would you feel about delivering the 
MoveStrong program in future? What might 
need to change? 
Related to your participation in the exercise 
program, what could we have done better? 
How is this program different from your 
current practice? 
What overall changes would you 
recommend to improve this program? 
Can you list certain exercises that participants 
enjoyed more than other exercises? 
 
What did you dislike about the exercise 
program? 
 
 
 
 
 
 
 
 
 
 
 
 
 

23 
 
Table 3: Variables, hypotheses, outcomes and methods of analysis 
1 where relevant, adjusted for period, time by exposure interaction & intra-cluster correlation. 2 Sensitivity analyses: with/without caregiver/friend. 
ITT = intention-to-treat analysis. Based on the initial treatment assignment and not on the treatment eventually received; PP = Per Protocol Analysis. Comparison 
of treatment groups that includes only those participants who completed the treatment originally allocated.
Variable 
Hypothesis 
Outcome Measures 
Methods of Analysis 
Primary 
Recruitment  
We will recruit 40 individuals, 10 per site 
Number recruited at each site 
Descriptive statistics or estimates 
based on 95% confidence intervals 
 
Retention 
We will retain 90% of our sample. 
Number of participants that we can gather data 
from at study end 
Adherence 
The average proportion of exercise sessions 
completed will be ≥70%. 
Average proportion of completed exercise 
sessions 
Secondary 
Frailty 
indicators 
Body weight, walking speed, chair stand 
performance and Four Square Step Test will 
be responsive to the intervention.  
Exposure will result in: 
 
maintained or increased body weight; 
 
faster walking speed 
 
less fatigue 
 
improved chair stand, Four Square Step 
test and grip strength 
 
increased physical activity level 
 
body weight in pounds 
 
10-metre walk test (seconds 
 
Center for Epidemiologic Studies 
Depression Scale-fatigue questions 
 
Stair Climb Test (seconds) 
 
30 Second Chair Stand (# of stands) 
 
Four Square Step Test (seconds) 
 
hand dynamometer (lbs) 
 
Physical Activity Scale for the Elderly 
score (0-793) 
Responsiveness: standardized 
response means, or mean change 
divided by the standard deviation of 
the changed scores.  
Exploratory intention to treat (ITT) 
and per protocol (PP) analyses: 
linear regression1,2 
Quality of Life 
Exposure will increase Quality Adjusted Life 
Years (QALYs) 
EQ5D5L – QALY 
Exploratory ITT and PP analyses: 
linear regression1,2  
Cost per life-
year gained 
No hypothesis at this time 
Questionnaires to assess resource use, 
documentation of costs of intervention 
 
Exploratory ITT and PP analyses: 
Ratio of incremental costs of 
intervention & QALY1,2 
Protein and 
energy intake 
Exposure will result in an increase in protein 
intake 
Nutrient analyses to estimate grams of protein and 
kilocalories, based on 3-day 24-hour recall at 
baseline and final visit only 
Exploratory ITT and PP analyses: 
linear regression1,2 
Participant, 
provider 
experiences 
Themes indicate positive experience, and 
identify needed adaptations 
Exit interviews 
Thematic analyses  
Harms 
No serious adverse events due to intervention Self-report of harms 
Descriptive statistics or estimates 
based on 95% confidence interval 

24 
 
Participant Timeline 
Table 4: Time schedule of enrolment, interventions, assessments, and visits for participants. 
Activity 
Staff 
Members 
T-1 
(Screen
ing/Con
sent) 
T0 
(Study 
visit 1) 
T1 
T2 
T3 
(Study 
visit 2) 
T3 
T4 
(Study 
visit 3) 
T5 
(Study 
visit 4) 
Recruitment 
and Screening 
 
 
 
 
 
 
 
 
 
In-clinic 
screening and 
referral 
Physician/del
egate 
X 
 
 
 
 
 
 
 
Inclusion/excl
usion form 
Outcome 
assessor 
blinded 
X 
 
 
 
 
 
 
 
Informed 
consent, 
contacts 
Outcome 
assessor 
blinded 
X 
 
 
 
 
 
 
 
Refusal 
questionnaire 
Outcome 
assessor 
blinded 
X 
 
 
 
 
 
 
 
Assessments 
 
 
 
 
 
 
 
 
 
FRAIL Scale 
Outcome 
assessor 
blinded 
X 
 
 
 
 
 
 
X 
Demographic 
questionnaire 
Outcome 
assessor 
blinded 
 
X 
 
 
 
 
 
 
Physical 
Activity Scale 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Verification of 
chronic 
disease(s) 
Outcome 
assessor 
blinded 
 
X 
 
 
 
 
 
 
Verification of 
frailty  
Outcome 
assessor 
blinded 
 
X 
 
 
 
 
 
 
Medical 
history and 
Mini-Cog 
Outcome 
assessor 
blinded 
 
X 
 
 
 
 
 
 
Medication 
review 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
EQ5D5L 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Body weight  
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 

25 
 
10 Meter Walk 
Test 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Stair Climb 
Test 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
30-Second 
Chair Stand 
Test 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
4 Square Step 
Test 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Grip Strength 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Center for 
Epidemiologic 
Studies 
Depression 
Scale-fatigue 
Questions 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Resource Use 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Automated 
Self-
Administered 
24-Hour 
Dietary 
Assessment 
Tool 
Outcome 
assessor 
blinded 
 
X 
 
 
X 
 
X 
X 
Adverse 
Events 
Protocol 
Kinesiologist 
 
X 
 
 
X 
 
X 
X 
Exit Interview 
Outcome 
assessor 
unblinded 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 

26 
 
Appendix B 
        
       
     
Participant Information Sheet and Consent Form  
 
Title of Project: MoveStrong: A Model for delivering Strength Training and Nutrition education 
for older adults  
Primary Investigator: Dr. Lora Giangregorio 
                 Professor and Schlegel Research Chair in Mobility and Aging 
      University of Waterloo, Department of Kinesiology 
      Tel: (519) 888-4567 Ext. 36357  
      Email: lora.giangregorio@uwaterloo.ca  
 
Co-investigators: Professor Heather Keller, Dr. Angela Cheung, Dr. Wanrudee Isaranuwatchai, 
Dr. Maureen C. Ashe, Dr. Alexandra Papaioannou, Dr. Marina Mourtzakis, Dr. Lehana Thabane, 
and Dr. Sharon Straus, Dr. Jamie Milligan, Mr. Larry Funnell, Ms. Sheila Brien, Dr. Zachary 
Weston 
Students or Trainees: Isabel Rodrigues, Justin Wagler 
Sponsors: Canadian Institutes of Health Research 
 
Your primary contact: 
Day Emergency Contact: (insert research assistant name and contact information for each site) 
 
Introduction 
You are being invited to participate in a research study. We have outlined the study here, and 
will discuss it with you. Please read this information carefully. Ask questions about anything 
that you want to know more about.  
 
Why is this research being done? 
Staying active and eating well can improve overall health and many people would benefit from 
learning how to exercise properly and eat healthy as they get older.  This study will test a new 
method to teach functional strength and balance exercises and encourage good nutrition among 
older adults with chronic diseases.   
 
What is the purpose of the study? 
Our team wants to investigate a new exercise and nutritional education program to see if it is a 
realistic way to deliver education on exercise and nutrition in the community. In order to do 
this, we need to do a small study first to see if it is possible to achieve this goal. The current 
study will recruit 40 individuals from across Ontario. The current study will be the first step to 

27 
 
evaluating whether it is possible to deliver an education program like MoveStrong in the 
community. 
 
What will your responsibilities be if you decide to take part in the study? 
You will be asked to participate in one visit to (insert site here) at the beginning of the study, 
and three additional visits during and at the end of the program. The study visit will take 
approximately two hours, and will include the assessments listed below. If you cannot complete 
an assessment, or do not wish to, you can still remain in the study. The only assessments that 
are mandatory are the assessments at the start to confirm that you are eligible to participate. 
We may also ask you to describe the study back to us in your own words so we can be sure you 
understand what we are asking you to do.  
Study assessments: 
1. A physical assessment that includes assessing your height, weight, and walking speed over 
10 meters. Balance and mobility tests include your ability to get up from a chair and sit 
back down for 30 seconds, and your ability to step over low objects while moving 
forward, backward, and sideway. We will also provide you with a number of 
questionnaires to assess your mood, quality of life, and diet.  
2. We will ask questions about your health and medical history, your perceived quality of 
life, the health services you use, your physical activity levels and your diet. We will also 
ask about illness or injuries that happen during the study. We may complete some of 
these over the phone. 
Other assessments: 
1. A phone number will be provided so that you can report any falls, injuries or health 
problems.  We will ask you to sign a form so that we can retrieve health records related 
to any injuries or illnesses you have.  
There are four locations taking part in this study. Each location will be randomly assigned a start 
date to the program. So, some people will start the program right away while others will start 3, 
6, or 9 weeks later. You will have a 1-on-1 session with a kinesiologist to determine which 
exercises are best for you. Then you will attend two group exercise sessions per week for 8 
weeks. Each session will have 3-6 participants. A kinesiologist will supervise the sessions. At the 
end of each sessions, there is a group discussion about how to perform exercise at home. If you 
have a friend or caregiver who is eligible to participate, or who would like to support you with 
your exercise, you are welcome to bring them. You will also attend two nutrition education 
seminars led by a dietitian. You will receive a booklet about nutrition and some snacks.  
 
What are the possible benefits of the study for me and/or society? 
We will provide you with the results of your assessments at the end of the study, so that you can 
see how you did. You will be allowed to keep all of the exercise and nutrition materials and you 

28 
 
will receive an exercise program from the kinesiologist. You will exercise in small groups where 
you will meet other participants. 
 
What are the possible risks and discomforts? 
There is a potential for exercise-related changes to occur during the assessments or exercise, 
such as muscle soreness and changes in blood pressure and heart rate. Any physical exercise or 
performance-based test is associated with a risk of falls or cardiovascular complications. We 
aim to minimize the risks by having the exercise prescription done by a certified kinesiologist, 
and by having training for all our staff.  
 
What information will be kept private and confidential? 
Your data will not be shared with anyone except with your consent or as required by law. All 
personal information will be removed from the data and will be replaced with an ID code. Your 
information will be stored at the study site in a locked cabinet. Any data that is stored in the 
computer will be encrypted and password protect. Paper and electronic records will be retained 
for 7 years after the study is complete, and study data will be retained for 20 years. All 
anonymized forms and study data will be stored in a locked office. Only the research team will 
have access to the data. Some of the data may be examined by students doing thesis projects or 
research internships, but your name or other identifying information will not appear with the 
data. 
Data 
will 
be 
secured 
in 
accordance 
with 
UW 
policies 
available 
at 
http://ist.uwaterloo.ca/security/policy/.  
Information about you will be obtained from your health records held at this and other health 
services for the purpose of this research. By signing the consent form you agree to the study 
team accessing health records if they are relevant to your participation in this research project. 
Your health records and any information obtained during the research project are subject to 
inspection (for the purpose of verifying the procedures and the data) by the relevant 
authorities and authorised representatives of the University of Waterloo or as required by law. 
By signing the Consent Form, you authorise release of, or access to, this confidential 
information to the relevant study personnel and regulatory authorities as noted above.  
It is anticipated that the results of this research project will be published or presented in a 
variety of forums. The results will be presented in such a way that you cannot be identified, 
except with your permission. You may be asked if you would like to have your photo taken 
during study activities for use in oral presentations, training information or publications. This is 
voluntary and not a requirement of the study. If you are to be photographed you will be asked 
to sign a separate consent form.  
Information about your participation in this research project may be recorded in your health 
records. 
Can I end my participation early?  

29 
 
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. You 
will receive the best possible care whether or not you take part. If you volunteer to be in this 
study, you may withdraw at any time. If you withdraw, you will be asked if there are some parts 
of the study you are still willing to complete (e.g., phone assessments only). You can opt out of 
only some parts of the study, or withdraw altogether. We will not withdraw previously 
collected data unless you request that we do. If you decide to withdraw from the project, 
please notify a member of the research team.  
 
Will I be paid to participate in the study? 
You will not be paid to participate in the study. We will reimburse parking or bus transportation 
costs for travel to study visits. If you lose your receipt you will be reimbursed for parking or bus 
based on the time you spent at the clinic visit. If you do not have access to transportation, we 
will pay for a taxi within a reasonable distance from our centre.  
 
What happens if I have a research-related injury? 
If you are harmed as a direct result of taking part in this study, all necessary medical treatment 
will be made available to you at no cost. 
By signing this form you do not give up any of your legal rights against the investigators, sponsor 
or involved institutions for compensation, nor does this form relieve the investigators, sponsor 
or involved institutions of their legal and professional responsibilities. 
If you have any urgent medical problem, injury or illness that is related to your participation in 
this study or have any questions, concerns or would like to speak to the study team for any reason 
please call:  
This project has been reviewed by, and received ethics clearance through, the Office of Research 
Ethics at the University of Waterloo. If you have any comments or concerns resulting from your 
participation in this study, contact Dr. Vanessa Buote at the Office of Research Ethics at 519-
888-4567 ext. 30321 or by email at vbuote@uwaterloo.ca 
 
Consent of Participant 
I have read the information presented in the information letter about a study, a model for 
delivering strength training and nutrition education for older adults (MoveStrong), being 
conducted by Dr. Giangregorio and colleagues or I have had it read to me in a language that I 
understand. I have had the opportunity to ask any questions related to this study, to receive 
satisfactory answers to my questions, and any additional details I requested. I understand the 
purposes, procedures and risks of the research described in the project. 
I am aware that I may withdraw from the study without penalty at any time by advising the 
researchers of this decision.  With full knowledge of all foregoing, I agree, of my own free will to 
participate in this study. I have been advised that I will receive a signed copy of this form 
Consent Statement 

30 
 
 
Name of Participant 
 
_______________________________________________ 
 
 
Signature of Participant 
 
 
 
 
Date 
 
_______________________________________________ _____________ 
 
Person obtaining consent:  
I have discussed this study in detail with the participant. I believe the participant understands 
what is involved in this study. 
 
Name, Role in Study 
Signature 
Date 
 
 
 
Name of Translator, if applicable 
   Language translated into 
 
_______________________________________________    ____________________________ 
 
Signature of Translator 
 
 
 
 
Date 
 
_______________________________________________ _____________ 
 
 
 
 
NOTE: This page should be given to the participant to keep  
 
 
 

31 
 
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