MoveStrong at Home: A Feasibility Study of a Model for Remote Delivery of Functional Strength and Balance Training Combined With Nutrition Education for Older Pre-frail Adults.
Phase: NA
Conditions: Arthritis, Cancer, Cardiovascular Diseases, Chronic Lung Disease, Congestive Heart Failure, Diabetes, Hypertension, Kidney Diseases, Obesity, Osteoporosis, Stroke, Frailty
Sponsor: University of Waterloo

 
 
 
 
 
 
 
 
 
MoveStrong at Home:  
A feasibility study of a model for remote delivery of functional strength and balance training 
combined with nutrition education for older pre-frail and frail adults. 
 
Registration: NCT04663685 
Date: February 8th, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Protocol 
The protocol was drafted in accordance with the CONSORT Statement for pilot studies 1 and 
the TIDieR checklist 2 and registered with ClinicalTrials.gov (NCT04663685). The study (ID: 
#42206) was reviewed and approved by the Office of Research Ethics at the University of 
Waterloo, Waterloo, ON.  
 
Intervention Development and Research Design 
MoveStrong was originally designed to provide a framework for exercise professionals to tailor 
fundamental strength exercises for older adults of varying abilities using minimal equipment. 
The functional movements were informed by the GLA:D program for arthritis 3, BoneFitTM  4, and 
meta-analyses on resistance exercise and fall prevention 5. Difficulty was meant to be 
progressed over time and ranged from simple seated exercises to compound movements with 
free weights. The nutrition component was developed following recommendations from the 
PROT-AGE group of 1.0-1.2g protein/kg of body weight/day for older adults, and more for active 
individuals or those living with acute or chronic illness 6. Achieving target levels of dietary protein 
was supported with a 30-page booklet, which included information, tips, and recipes.  
 
This project was built upon the MoveStrong pilot that was first delivered in person across five 
different sites in Ontario from March 2019 to March 2020 7. The original in-person study 
included twice-weekly exercise sessions and two nutrition sessions over an 8-week period. The 
small group classes (4-5 participants) were delivered by a registered kinesiologists or exercise 
physiologists, and registered dietitians in community centres and retirement homes. When the 
COVID-19 pandemic brought on a nation-wide lockdown, the protocol was adapted for remote 
implementation by engaging patient partners and key stakeholders. During the first wave of the 
pandemic, we identified team members including researchers and health care providers with 

 
 
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clinical expertise working with individuals living with frailty. Patient partners from Osteoporosis 
Canada and representatives from community organizations were contacted. By consulting 
diverse stakeholders, we were better able to understand issues and considerations for adapting 
MoveStrong to a virtual platform, identify priorities for the intervention, and come up with 
realistic solutions. A joint decision-making process was used during two hour-long meetings to 
modify the program.   
 
Sample Size 
We selected a recruitment goal of ≥25 people over 12 weeks as a pragmatic sample size to 
understand feasibility of intervention delivery and participant experience 30. No formal sample 
size calculation was made as our aim was to assess the feasibility of the intervention, and not 
the effectiveness of the protocol. 
 
Recruitment 
A convenience sample was recruited from email contact lists of individuals who previously 
agreed to be notified of research opportunities. In addition, we asked colleagues and 
collaborators (Research Institute for Aging, Centre for Community Clinical and Applied 
Research Excellence, Osteoporosis Canada, Community Support Connections, YMCA) to 
forward the link to potential participants on their distribution lists. Research support staff and 
kinesiologists at three local retirement homes recruited participants using flyers and word of 
mouth. Primary care professionals were provided with electronic flyers and posters to use in 
their practice. Lastly, Twitter (Twitter Inc. 2020) and Facebook (Facebook Inc. 2020) were used 
to share the recruitment post with relevant professional groups and local neighborhood 
associations (e.g., Connected Kinesiologists, Eastbridge Neighborhood Association).  
 

 
 
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Eligibility Criteria 
We recruited English speaking Ontario residents, ≥ 60 years of age, with ≥1 self-report chronic 
condition (e.g., diabetes, obesity, cancer, chronic lung disease, cardiovascular disease, 
hypertension, osteoporosis, arthritis, stroke), and ≥1 FRAIL scale score (fatigue, resistance, 
ambulation, illnesses, and loss of weight) 8. For the purpose of telephone screening, the FRAIL 
Scale questionnaire was used as a time efficient tool. Individuals were ineligible if they were 
completing similar progressive strength training exercises ≥2x/week (or had completed similar 
training within <6 months of recruitment); were receiving palliative care; could not perform basic 
activities of daily living; had moderate to severe cognitive impairment (e.g., unable to follow two-
step commands); planned to travel >1 week; or met any ACSM absolute exercise 
contraindications 8.  
 
Upon screening, the consent form was mailed or emailed to all eligible individuals. The research 
assistant reviewed the form by telephone a week after the initial screening call or upon arrival of 
the documents by mail. Informed consent was obtained verbally and documented using a 
standardized form.  
 
Intervention Description  
Overview 
MoveStrong at Home was delivered as an 8-week home-based exercise and nutrition program 
with a 4-week follow-up. The intervention and all data collection were implemented remotely via 
telephone and virtually to community-dwelling older adults in their homes, or to older adults 
living independently in a retirement home setting. We used the Knowledge-to-Action (KTA) 
framework to guide implementation 9 and addressed known barriers to participation using 28 
Behaviour Change Techniques 10 that targeted 6 Intervention Functions 11. 

 
 
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Upon enrollment, program instructions, a nutrition education booklet, and an exercise band 
were mailed to participants. A research assistant delivered a 60-minute technology session to 
each participant to help familiarize them with the Physitrack/Physiapp® (Physitrack PLC. 2021), 
and Microsoft Teams® (Microsoft Corporation. 2021) platforms. The exercise physiologist was 
given an instructor manual that provided guidance on chronic conditions, common movement 
impairments, safety reminders, cueing tips, and procedures for reporting adverse events. The 
exercise physiologist then delivered 11 one-on-one sessions to each participant. A registered 
dietitian completed an orientation session on the protein focus of the intervention and was 
provided with the MoveStrong nutrition education booklet and access to five online videos. The 
dietitian led three group nutrition sessions with the purpose of addressing participants questions 
on how to increase protein content in their diet.  
 
Meet & Greet 
Before starting the intervention, participants received a 60-minute consultation with the exercise 
physiologist to review program instructions. Together, the exercise physiologist and the 
participant decided when they would meet weekly for their one-on-one sessions. Participants 
were encouraged to dedicate space in their home and leave their materials and equipment in 
the designated location. 
 
One-on-one Exercise Training 
Using what they gathered from the Meet & Greet session and baseline measures, the exercise 
physiologist created an individualized program for each participant on Physitrack® or mailed a 
printed copy to their home. Physitrack® is a commercially available platform which the exercise 
physiologist used to prescribe exercises, monitor adherence, and respond to incoming 

 
 
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messages. An add-on subscription provided teleconferencing minutes on a secure and user-
friendly interface. Each individualized training program included at least 7 functional movements 
and alternated between upper and lower body to enhance recovery – Balance, Pull, Squat, 
Push, Hinge, Lift & Carry and Calf Raise. Participants were asked to perform 8-10 repetitions of 
each functional movement with time under tension per repetition of 4:0:2 seconds for 
eccentric:isometric:concentric phases. Exercise variation, resistance, or volume (up to 3 sets) 
were progressed over time. Participants were able to access their program through the 
participant portal – Physiapp®, where they reported adherence (i.e., reps, sets, RPE) and 
provided feedback (e.g., pain).  
 
In addition to the Meet & Greet session, the exercise physiologist met each participant twice 
during weeks 1-2, and then once from weeks 3-8 (11 sessions total). At the start of every one-
on-one session, the exercise physiologist inquired about changes to health status. The exercise 
physiologist then confirmed weekly exercise adherence (as reported on Physiapp®) and 
reminded participants to remove tripping hazards and ensure a support object was nearby. 
Warm up consisted of 2-4 dynamic range of motion movements that target major muscle groups 
and joints in the body. The exercise physiologist led participants through 1-2 static and dynamic 
balance exercises that reduced base of support, shifted focus, or required multitasking. Then 
the exercise physiologist demonstrated functional movements, discussed the importance of 
each exercise and what muscles it engaged. Cool down consisted of 3-4 static stretches that 
were held for 30-60 seconds on each side and repeated. 
 
Group Nutrition Question & Answer Sessions 
Participants received a nutrition booklet that included detailed guidance, useful tips, and high 
protein recipes. Five educational videos were available on a private YouTube® channel (Google 

 
 
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LLC. 2021) to help reinforce key topics (Reading nutrition labels, Plant-based proteins vs. 
animal proteins, Protein foods, Ways to incorporate protein into your meals and snacks, 
Spreading protein throughout the day). In addition, individuals participated in three 60-minute 
dietitian-led nutrition discussion sessions over Microsoft Teams® on weeks 2, 4, and 6. The 
purpose was to review content from the booklet and videos and discuss more personalized 
strategies to increase protein intake.  
 
Group Discussion Sessions 
Optional group discussion sessions were delivered over Microsoft Teams® by a research 
assistant, and took place on weeks 3, 5 and 7. The intention was to foster a sense of 
community, consider strategies to support adherence to the intervention, and introduce behavior 
change techniques. A PowerPoint presentation was used to present key concepts, share 
motivational quotes, and pose discussion questions during the 60-minute sessions. Individuals 
took turns sharing their experiences and responding to one another.  
 
Outcomes (Primary, Secondary, Process, Qualitative Interviews) 
The primary outcomes were feasibility of community and network recruitment, retention at 
follow-up, and adherence to the exercise and nutrition components. During supervised 
sessions, adherence was assessed by an exercise physiologist or research assistant. For 
independent exercise sessions, adherence was self-reported through Physiapp® or recorded 
using the sheets provided. 
 
Secondary outcomes were measured by telephone, an online survey platform (Qualtrics®) or 
virtually over Microsoft Teams® at three time points – baseline, program end and at follow-up (4 
weeks after program cessation). Questionnaire responses were stored in the Qualtrics® data 

 
 
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centre (SAP. 2020) and Food Recall entries were stored on the ASA24 database (National 
Cancer Institute. 2018).  
 
Analysis 
 
Primary outcomes of recruitment, retention, and adherence were reported using descriptive 
statistics and compared to a priori criteria to determine feasibility. Baseline sociodemographic 
and health information was reported using descriptive statistics including mean (95% CI) for 
continuous or frequency (%) for categorical variables. Secondary outcome data was cleaned, 
organized, and inputted into SPSS 27 (IBM Corp. 2020). We conducted exploratory analyses of 
baseline to end of study and baseline to follow-up differences using paired (dependant) samples 
t-tests. We used complete case analyses. We presented effect estimates as mean differences 
(95% CI). We reported adverse events at a patient level (# of events, # of people who had 
events) and process outcomes via count (#) and percent (%).  
 
We transcribed interviews verbatim and analyzed them using NVivo version 12 Pro (QSR 
International Pty Ltd. 2020). We followed an inductive qualitative description approach to code 
perceived benefits and suggestions for future studies 12. The inductive process began with open 
coding where units of meaning were organized into fluid code categories. We used nine 
transcripts to create a basic framework which was then applied to the remaining transcripts 
(EW). The codes were analyzed and reviewed by two research assistants and discrepancies 
were settled through discussion (EW & AS). In conjunction, we used content analysis to identify 
facilitators of and barriers to behaviour maintenance which were mapped to Transtheoretical 
Domains Framework (TDF) 13,14. The deductive process involved identifying and grouping 
related codes (facilitators and barriers) together into appropriate sub-categories to condense 

 
 
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text while staying close to the data (EW). Finally, the sub-categories (constructs) were mapped 
to 11 domains of the TDF (EW).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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References 
1.  
Eldridge SM, Chan CL, Campbell MJ, et al. CONSORT 2010 statement: extension to 
randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi:10.1136/bmj.i5239 
2.  
Hoffmann TC, Glasziou PP, Boutron I, et al. Better reporting of interventions: template for 
intervention description and replication (TIDieR) checklist and guide. BMJ. 
2014;348(mar07 3):g1687-g1687. doi:10.1136/bmj.g1687 
3.  
Skou ST, Roos EM. Good Life with osteoArthritis in Denmark (GLA:DTM): evidence-based 
education and supervised neuromuscular exercise delivered by certified physiotherapists 
nationwide. BMC Musculoskelet Disord. 2017;18(1):72. doi:10.1186/s12891-017-1439-y 
4.  
Giangregorio LM, Papaioannou A, MacIntyre NJ, et al. Too Fit to Fracture: Exercise 
recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. 
Osteoporos Int. 2014;25(3):821-835. doi:10.1007/s00198-013-2523-2 
5.  
Sherrington C, Fairhall NJ, Wallbank GK, et al. Exercise for preventing falls in older 
people living in the community. Cochrane Database Syst Rev. 2019;2019(1). 
doi:10.1002/14651858.CD012424.pub2 
6.  
Bauer J, Biolo G, Cederholm T, et al. Evidence-based recommendations for optimal 
dietary protein intake in older people: A position paper from the prot-age study group. J 
Am Med Dir Assoc. 2013;14(8):542-559. doi:10.1016/j.jamda.2013.05.021 
7.  
Rodrigues IB, Wang E, Keller H, et al. The MoveStrong program for promoting balance 
and functional strength training and adequate protein intake in pre-frail older adults: A 
pilot randomized controlled trial. PLoS One. 2021;16(9 September):e0257742. 
doi:10.1371/journal.pone.0257742 
8.  
Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts 
outcomes in middle aged african americans. J Nutr Heal Aging. 2012;16(7):601-608. 
doi:10.1007/s12603-012-0084-2 
9.  
Graham ID, Logan J, Harrison MB, et al. Lost in knowledge translation: Time for a map? J 
Contin Educ Health Prof. 2006;26(1):13-24. doi:10.1002/chp.47 
10.  
Michie S, Richardson M, Johnston M, et al. The behavior change technique taxonomy 
(v1) of 93 hierarchically clustered techniques: Building an international consensus for the 
reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81-95. 
doi:10.1007/s12160-013-9486-6 
11.  
Michie S, van Stralen MM, West R. The behaviour change wheel: A new method for 
characterising and designing behaviour change interventions. Implement Sci. 
2011;6(1):1-12. doi:10.1186/1748-5908-6-42 
12.  
Sandelowski M. Whatever happened to qualitative description? Res Nurs Health. 
2000;23(4):334-340. doi:10.1002/1098-240x(200008)23:4<334::aid-nur9>3.0.co;2-g 
13.  
Krippendorff K. Content Analysis: An Introduction to Its Methodology.; 2018. 
doi:10.7748/paed.20.6.38.s27 
14.  
Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in 
behaviour change and implementation research. Implement Sci. 2012;7(1):1-17. 
doi:10.1186/1748-5908-7-37 

 
 
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Appendix 1: Participant Information Sheet and Consent Form  
Title of Project: MoveStrong at Home 
Primary Investigators:  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Co-investigators:  
Sheila Brien, Larry 
Funnell, Dr. Marina Mourtzakis, Dr. Jamie Milligan, Dr. Maureen Ashe, Dr. Alexandra Papaioannou, 
Dr. Lehana Thabane, Zach Weston, Dr. Angela Cheung, Dr. Sharon Straus 
Students or Trainees: Ellen Wang 
 
Sponsors: Network for Aging Research 
 
Introduction 
You are being invited to participate in our research study. This letter will explain what the study is about, the 
possible risks and benefits, and your rights as a research participant. If there is something in this letter that you 
do not understand, please ask one of the study staff. Please feel free to discuss this with your family, friends, 
or family physician before you decide to participate. 
Your participation is voluntary. It is up to you to decide whether or not you wish to take part. If you decide to 
participate, you are still free to withdraw at any time and without giving any reasons for your decision. Your 
decision to participate or not will not affect your relationship with the study staff or the university. 
Who is conducting this study? 
This study is being conducted by researchers at the University of Waterloo. The study is sponsored by the 
Network for Aging Research. 
Why is this research being done? 
We lose muscle mass and strength as we age. Exercise can help maintain muscle and improve balance, 
especially in pre-frail and frail individuals. Eating the right kinds of foods to support muscle is also important. 
However, getting enough physical activity and protein can be a challenge, especially with mandated social 
distancing practices. Alternate ways to promote safe exercise and proper nutrition are more needed than ever 
before.  
What is the purpose of the study? 
We want to evaluate if it is possible to deliver exercise and nutrition education over the phone or computer. In 
addition, we wish to understand barriers, facilitators, and participant experiences with remote delivery. We also 
Dr. Lora Giangregorio 
Professor 
University of Waterloo, Department of 
Kinesiology 
Tel: (519) 888-4567 ext. 36357  
Email:lora.giangregorio@uwaterloo.ca  
 
Dr. Heather Keller 
Professor 
University of Waterloo, Department of 
Kinesiology 
Tel: (519) 888-4567 ext. 31761 
Email: hkeller@uwaterloo.ca 

 
 
11 
 
 
want to see if there are changes in your mobility, physical activity levels, diet, mental health, and quality of life 
after participation in the program.  
What will your responsibilities be if you decide to take part in the study? 
The study takes place over 12 weeks (about 3 months). You do not need to leave your house to participate in 
the study. You can choose to communicate with us via telephone, or online using your computer, or a little of 
both – it is up to you.  
We will complete each of the following assessments of your health, physical activity, physical function and 
nutrition over the phone or computer at the beginning of the study, after the 8-week intervention, and one 
month later (12-weeks). These assessments will allow you and the research team to monitor changes in 
physical function, nutrition and well-being that result from this education program.  
- 
We will call you to complete questionnaires physical activity beliefs and participation, dietary habits, 
fatigue, mental health, and quality of life (60 minutes). You can choose to complete the questionnaires 
and physical function assessments on your own and mail them in. 
- 
We will call or video call you to assess your physical function. We will assess whether you can maintain 
balance in different standing positions and how many times you can get in and out of a chair in 30 
seconds (~15-30 minutes).  
- 
 
*An undergraduate student will be present during your baseline assessments to observe the physical 
function assessments. They will ask you to share your expectations, difficulties you faced and 
suggestions to improve the balance and chair stand tests using a brief online survey using Microsoft 
Forms. We ask your permission to record the physical function assessment (at baseline) as a video or 
voice recordings over Microsoft Teams so we may evaluate and improve the process. 
- 
We will call you over 3 days to ask you about the foods and drink you have consumed (~30-45 minutes 
each) 
You will be asked to participate in web conference or telephone sessions to learn about exercise and nutrition. 
The exercise sessions will be led by an exercise physiologist, who will tailor exercises to your needs and 
answer any questions you may have. In addition, they will inquire about illnesses or injuries at the beginning of 
every session, monitor your progress throughout, and remind you to practice on your own at the end of every 
session. The private exercise sessions will happen twice a week on non-consecutive days to start, with each 
session lasting 30 minutes. As you progress, you will be encouraged to complete more exercise independently 
outside of the structured session. Every participant will be continuing to receive one private session per week 
after the first two weeks of the intervention. If attending by phone, there is an option to continue with a second 
private session. You will also receive nutrition and exercise education materials in the mail. At weeks 2, 4, and 
6 of the study, you will be invited to attend a virtual group seminar led by a dietitian to learn about nutrition and 
protein intake. At weeks 3, 5, and 7 of the study, you will be invited to attend an optional group session to 
discuss and practice behavior change strategies to help you sustain your new exercise and nutrition habits. 
Before the start of study, you will complete demographic information and various questionnaires online using 
Qualtrics. A link to their privacy policy can be found here: https://www.qualtrics.com/privacy-statement/. You 
may also to choose to complete them over the phone or by mail. Then, we will schedule a 30-minute 

 
 
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technology consultation to teach you how to attend private training sessions by web conference and telephone 
using Physitrack, a telehealth system that offers secure communication between participants and exercise 
leaders. Physitrack abides by the safety and access standards set forth by the Information and Privacy 
Commissioner of Ontario. All data is stored in the Canadian databases on Amazon Web Services in Montreal. 
A link to their privacy policy is available here: https://www.physitrack.com/privacy. Microsoft Teams, an 
externally hosted cloud-based service, will be used to deliver all group trainings sessions including nutrition 
seminars and virtual support groups. The Canadian Data Centre for Microsoft Teams is located in Quebec City 
and Toronto. A link to their privacy policy is available here: https://www.microsoft.com/en-ca/trust-
center/privacy?rtc=1 . In the case that participants are unable to use Physitrack® due to incompatibilities with 
their electronic device, Cisco WebEx® will be used instead 
[https://trustportal.cisco.com/c/dam/r/ctp/docs/privacydatasheet/collaboration/cisco-webex-meetings-privacy-
data-sheet.pdf]. 
At the end of the study and at follow-up, we will invite you to share your experience during a 30-minute 
interview. We would like to audio record the interviews using Microsoft Teams so we can revisit your 
responses and transcribe them for analysis.  
Who may participate in the study? 
Our study will recruit 25 older adults in Ontario. You are eligible to participate if you are aged 60 or over; 
speak English; receive a score of 1 or greater on our FRAIL Scale (chronic fatigue, difficulty walking 100 yards, 
difficulty with stairs, >5 chronic conditions, weight loss >10lbs within the last year); and have 1 or more 
diagnosed conditions (e.g., diabetes, cancer, heart failure, arthritis). 
 
Who is not be eligible? 
You are not eligible to participate if you are doing similar exercises 2 or more times per week; cannot do 
basic activities of daily living or follow 2-step commands; are receiving palliative care; or have contraindications 
to exercise. If you have health conditions that may get worse if you participate in exercise, or if you think your 
physician may have concerns about your participation, we may need to consult your physician prior to 
including you in the study. 
What are the possible benefits of the study for me and/or society? 
You will receive advice and materials on nutrition and exercise. The exercise and nutrition materials are yours 
to keep. We will provide you with the results of your assessments at the end of the study, so you can see how 
you did. Our study will help society in that we will learn about how to deliver exercise and nutrition remotely. 
What are the possible risks and discomforts? 
There is a potential for exercise-related changes to occur during the assessments or exercise sessions, such 
as muscle soreness and changes in blood pressure or heart rate. Any physical exertion, including 
performance-based tests, are associated with a risk of falls, injuries, or cardiovascular complications. It is 
possible for you to sustain a fracture or injury during physical activity. We aim to minimize the risks by training 
our staff and having the exercises selected by an exercise physiologist. You may choose not to perform an 
exercise or request a modified version at any time. 
What information will be kept private and confidential? 

 
 
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Some of the exercise or nutrition sessions may take place in a live, virtual group setting on Microsoft Teams, to 
promote interaction and learning from each other. Other participants in the study may be able to see your 
name or your face on screen or hear you during the session. We ask that you keep other’s identities or things 
we discuss in the sessions private. We cannot guarantee the confidentiality of anything you say during group 
sessions, so please do not say anything that you would not feel comfortable saying in public. You may choose 
not to participate in the group sessions. 
Your data will not be shared with anyone except with your consent or as required by law. All personal 
information will be removed from your data and will be replaced with an ID code. Data stored this way is 
referred to as “de-identified data”. Paper and electronic records will be retained for 7 years after the study is 
complete. All de-identified forms and study data will be stored in a locked cabinet in our private office or on a 
secure network drive. All data collection files will be password-protected. Only approved members of the 
research team will have access to the lab, network drives, and further, the passwords for encrypted 
documents.  
Voice, video recordings & survey responses will be immediately moved to a password protected folder on the 
University of Waterloo network drive and deleted from the Microsoft server. While this service is approved for 
collecting data by the University of Waterloo Research Ethics Board, there is a small risk for the data collected 
on external servers to fall outside the control of the research team. Likewise, when information is transmitted 
over the internet, privacy cannot be guaranteed. There is always a risk your responses may be intercepted by 
a third party (e.g., government agencies, hackers). University of Waterloo researchers will not collect or use 
internet protocol (IP) addresses or other information which could link your participation to your computer or 
electronic device without first informing you.  
We may use the data to answer research questions other than those described here. 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. By consenting to participate in this study, you are providing 
permission for future use of your data.  
Can I end my participation early?  
Participation in this research is voluntary. If you do not wish to take part, you don’t have to. If you volunteer to 
be in this study, you may withdraw at any time by notifying a member of the research team. 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 so, or if the results have already been analyzed or published. We will not withdraw any 
safety data.  
If you are withdrawing for personal or health-related reasons and we cannot confirm your direct consent (e.g., 
a family/friend informs us they are withdrawing) we will not contact you further, but we will include de-identified 
data collected to that point. 
Will I be paid to participate in the study? 
You will not be paid to participate in this study. 
 
Will the study cost me? 
You will not be charged for any activities in the study. 

 
 
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What happens after completion of the study? 
We will inform you of your individual results and the overall study results after we have analyzed all data. This 
will be in the form of a letter to you. 
What happens if I have a research-related injury? 
 
If you sign this consent form, it does not mean that you waive any legal rights you may have under the law, nor 
does it mean that you are releasing the investigators, institutions and/or sponsors from their legal and 
professional responsibilities. If you are found to be harmed as a direct result of taking part in this study, all 
necessary medical treatment will be made available to you at no cost. 
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:  
Anytime number for general question, to report concerns or injuries, or to make changes/cancellations to 
scheduled meetings: 519-904-0660 extension 5021.  
For all other questions contact Lora Giangregorio at phone 519-888-4567 extension 46357. 
 
 
Consent of Participant 
• 
I have read the information presented in the information letter about the study, MoveStrong at Home, 
being conducted by Lora 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.   
 
This study has been reviewed and received ethics clearance through a University of Waterloo Research Ethics 
Committee (ORE#42206). If you have questions for the committee, contact the Chief Ethics Officer, Office of 
Research Ethics, at 1-519-888-4567 ext. 36005 or ore-ceo@uwaterloo.ca. For all other questions, contact Lora 
Giangregorio at phone 519-888-4567 extension 46357. 
 
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. 
 
 
On ____________________, ____________________________ gave verbal consent to participate.  
                      Date                              Name of participant  
 
 
 
The person stated above has provided verbal consent to have their interviews audio recorded.  
YES  NO 
 

 
 
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The person stated above has provided verbal consent to have their physical function assessment video 
recorded.  YES  NO 
 
The person stated above has provided verbal consent to the use of anonymous quotations in any thesis or 
research paper related to this research project.  YES  NO 
 
The person stated above has provided verbal consent to the use of their data in future research. YES  NO 
 
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

Informed Consent Checklist 
 
 

 
 
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Confidence to Explain Research Study (Capacity to Consent) 
 
Questions to ask potential participants who are suspected to be cognitively impaired: 
“I want to make sure that you understand what the study is about. Would you mind describing in your own 
words what we are asking you to do as part of the study?” (The potential participant should be able to recite 
relevant details regarding the study) 
Prompts:  
• 
What are we asking you to participate in?  
• 
What does the study involve? 
• 
How long is the study? 
 
Participant answers must include:  
 An exercise and nutrition education program, delivered by phone or video conference 
 A variety of questionnaires and assessments 
 8 weeks in length or a total time commitment of 12 weeks 
 
_____ Participant answers include all relevant details; they are eligible to participate 
 
_____ Participant answers lack relevant details; they are ineligible to participate 
 
 Complete the Ineligibility Script 
Reason for ineligibility: Inability to explain research study (lack capacity to consent) 
Explanation: For the safety and well-being of participants, MoveStrong at Home requires that 
individuals have the ability to listen, reflect and execute complex commands that involve 
coordinating the entire body.