The purpose of this study is to evaluate different types of exercise programs on the physical and mental health of older adults during the current COVID-19 Pandemic. Specifically, if you chose to enrol in this study, you will be randomly allocated to one of three groups. These include (a) taking part in a 12-week (virtual) group-based exercise program for older adults, (b) taking part in a 12-week personal exercise program, or (c) being in a wait-list control condition whereby you will have the opportunity to take part in the personal exercise program at the end of the 12-week period
A growing body of evidence suggests that, among older adults, physical activity is associated with a number of important physical and mental health outcomes (e.g., functional capacity, quality of life, reduced likelihood of illness). Becoming or staying physically active during the COVID-19 Pandemic is going to be a challenge for many people, including those who are not already physically active, those affected by the stay-at-home order, and those without outdoor space that allows for the recommended two meters (six feet) of physical distance between people. Given the current stay-at-home mandates as part of the current COVID-19 Pandemic, we are interested to see how different exercise programs are related to measures of physical and mental health among older adults. We anticipate that the results of this trial will be invaluable in informing program delivery and potentially policy in terms of how older adults are supported in the current Pandemic (or others in the future).
Your participation is entirely voluntary. You may choose whether or not to take part in this study. Before you decide, it is important for you to understand what the research involves. This page will inform you about the study, why the research is being done, what you will be asked to do during the study and the possible benefits, risks and discomforts. If you wish to participate, you will be asked to sign a consent form. If you do decide to take part in this study, you are still free to withdraw at any time and without giving any reasons for your decision. If you do not wish to participate, you do not have to provide any reason for your decision not to participate.
Please take the time to read the following information carefully and to discuss it with your family, friends, and doctor before you decide.
To participate, you must be 65 years of age or older, and free of major health problems that may limit your ability to exercise. You must currently be participating in no or very little physical activity (less than 150 minutes of moderate-to-vigorous intensity activity per week). You need to be currently living in Canada, and also be able to read and understand English. You must be able to access the internet at home via a personal smartphone, tablet (e.g., iPad), or computer that has camera functionality. Only one participant per household can participate in the study. (Note: Spouses, significant others, or family members can take part in the exercise programs with a study participant; however, they will not be able to provide data and won’t be compensated for participating.)
You will be unable to participate in the study if you have a medical history or a current medical condition affecting your heart, lungs, or capacity to exercise. If, for any reason, you are unable to perform moderate-intensity or exercise, you should not participate in this study.
If you are already engaging in regular exercise on a daily or almost daily basis, you cannot participate.
Finally, if an individual is a non-English language participant, unable to understand the risk that may be associated with participating in this study, or who may not be able to adequately understand the questionnaires they will be asked to complete, they are able to participate in the study.
This study takes place in your own home. Approximately 600 older adults (aged 65 years or older) from across Canada will be enrolled in this study. If you volunteer to participate in this research, the research coordinator will schedule a time to determine if you qualify for the study via a set of pre-determined screening questions. Should you qualify for study participation, you will be invited to provide informed consent, after which you will be asked to complete a baseline questionnaire. After completing the baseline questionnaire, participants will be randomized to one of three trial conditions, and then asked to complete a questionnaire (taking about 10 minutes on each occasion) once every two weeks for 12 weeks. If you are randomized to receive one of the two exercise programs, you will be invited to take part in three exercise sessions each week (this amount equates to the current recommended guidelines of 150 minutes of moderate-intensity physical activity per week) for 12 weeks, with classes/sessions lasting 50-60 minute. By taking part in this study, these physical activity programs will be FREE to you. For those randomized to the wait-list control condition, you will have the opportunity to access and take part in a personal exercise program after 12 weeks (again, at no cost). Participants in all three conditions will receive $10 on each occasion that they complete the study questionnaires (7 questionnaires in total over 12 weeks = $70 per person).
The exercises performed in the programs involve movements of daily living and are safe to perform. Nevertheless, fatigue and physical discomfort may be experienced due to physical exertion during exercise, depending on your fitness level. To ensure that you are suitable to engage in moderate-intensity physical activity without negative consequences to your health, you will be asked to complete a screening measure. Depending on the results of that screening (based on your level of readiness to engage in physical activity) you may also be asked to obtain clearance from your physician, before you can participate in this study. Of course, it is also recommended that if you do experience any physical discomfort when you exercise that you contact your family physician.
The results of this study have the potential to shed important light on what types of exercise programs are most likely to be enjoyed by older adults and how they contribute to their physical and mental health during the current Pandemic. There is no guarantee that the study will benefit you. However, there is strong evidence that physical activity not only improves our physical health, but also mental health, symptoms of mood disorders, positive emotions, and our sense of control. Regular physical activity can also reduce the risk of developing a mental illness, such as depression or anxiety. There have already been reports of the stay-at-home order having negative impacts on mental health, and so this physical activity intervention may potentially reduce the negative impacts on mental health and possibly improve mental health and wellbeing during the COVID-19 Pandemic. By participating in this program, you will not only be contributing to important research, but you will also be contributing to your own physical and mental health. What’s more, you will not need to pay any fees to participate in this physical activity program. It’s completely FREE, and we will pay you for participating (by completing the study questionnaires)!
The main risks of this exercise intervention are that of normal moderate-intensity exercise. Exercise has normal and common side effects, particularly when you are new to physical activity; during the exercise session you can expect some shortness of breath, and muscle soreness/discomfort. After exercise, it is normal for some muscle stiffness and soreness, joint stiffness, and tiredness to occur. Exercise carries the risk of injury, including fractures, muscle strains, sprains, skin lesions, and tissue inflammation. Ensuring a good warm-up, keeping your exercise environment distraction- and object- free, and not overtraining reduces the risk of these injuries significantly.
In addition, in the questionnaires that will be used in this study we will ask you various questions about your physical and mental health (e.g., psychological well-being, stress). If, over the course of this study, or afterwards, you experience any distress the Government of Canada and British Columbia have provided a list of resources (including counseling as well as 24/7, confidential health information and advice). This information can be accessed at:
- Government of Canada’s Mental Health supports (https://ca.portal.gs/?lang=en-ca)
- Crisis Centre BC (https://crisiscentre.bc.ca/)
- Mental Health Commission of Canada ( https://theworkingmind.ca/sites/default/files/twm_self-care-resilience-guide.pdf)
- MindHealthBC ( http://www.mindhealthbc.ca/)
Each week we would like those in the exercise groups to complete at least 3 exercise workouts applicable to the group you are assigned, so you will need to plan your weeks to fit in these workouts. As these are at home, unsupervised workouts, ensure you have eaten within a couple of hours of exercise, your environment is relatively distraction-free and safe, and discontinue exercise and contact the research team if you are concerned about your ability to complete the program. If you are in the control group, we ask you to maintain your pre-study activity levels until the end of the 12-week period, when you will be given access and instructions for the use of the personal exercise program. You will be asked to fill out surveys, and we require these to be as accurate and timely as possible.
All information will be kept confidential. All data and computers storing this data will be encrypted, password-protected, and held in the laboratory of the Principal Investigator.
All survey data collected in this study is done so via Qualtrics, which is FIPAA compliant. All results produced will be from group data, and no individuals will be identified. Remember, that your participation is completely voluntary.
A description of this clinical trial will be available on http://osf.io and clinicaltrials.gov. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search for this website at any time.
Your rights to privacy are legally protected by federal and provincial laws that require safeguards to ensure that your privacy is respected. You also have the legal right of access to the information about you that has been provided to the researcher and, if need be, an opportunity to correct any errors in this information.
Your de-identified research data may be published or deposited into a publicly accessible location at the time of publication. This data could include the data collected during the screening questionnaires, study surveys, and exercise information from the Canvas web-platform that will be hosting the programs (this is a secured web-platform hosted by UBC). This means that other researchers may analyze the data for different reasons other than those described in this consent form. Once the data is made publicly available, you will not be able to withdraw your data. At no time will identifying information, such as your name, birth date or street address be included in such data.
Your participation in this research is entirely voluntary. You may withdraw from this study at any time without giving reasons. If you choose to enter the study and then decide to withdraw at a later time, you have the right to request the withdrawal of your information and surveys collected during the study. This request will be respected to the extent possible. Please note, however, that there may be exceptions where the data will not be able to be withdrawn, for example where the data are no longer identifiable (meaning they cannot be linked in any way back to your identity) or where the questionnaire data has been merged with other data. If you would like to request the withdrawal of your data and samples, please let the research team know.
If you have any questions or desire further information about this study before or during participation, you can contact Dr. Ryan Hulteen. His contact information is listed at the top of the first page of this form. You may also contact the Principal Investigator, Dr. Mark Beauchamp at (604) 822 4864 or by email at email@example.com.
If you have any concerns or complaints about your rights as a research participant and/or your experiences while participating in this study, contact the Research Participant Complaint Line in the UBC Office of Research Ethics at 604-822-8598 or if long-distance email RSIL@ors.ubc.ca or call toll free 1-877-822-8598. Please reference the study number [H20-01515] when calling so the Complaint Line can better assist you.
Yes, for more information please see www.copetrial.ca