Participant Safety in Physical Activity Studies

The purpose of this guideline is to provide strategies to researcher planning studies that include physical activity. It also includes reporting requirements if an adverse event does occur in the course of the research.

Participant Screening as Part of Determining Study Inclusion

To reduce the risk of adverse events related to participation in studies that include some element of physical activity (e.g., exercise, physical exertion, prolonged standing/balance tasks), it is best practice to include screening related to readiness to participate in physical activity. The two most common methods of doing so are by completing either of the following freely available resources.

In each questionnaire, the first section includes a series of YES or NO questions that assess the risks associated with participating in physical activity and flag any potential issues that could lead to adverse health effects. Generally, these questions relate to history of cardiovascular issues (heart disease, chest pain during exercise, high blood pressure), dizziness, shortness of breath, fainting, concussions, and history of physical injury. Additionally, both questionnaires screen for doctor or health care provider warnings or recommendations to avoid physical activity (unless medically supervised).

Answering yes to any question indicates that there may be some risk associated with participating in physical activity. A yes response will then lead to additional screening questions that help identify the level of risk (based on type and severity of conditions), as well as determine if physical activity (and thus, participation in the study) is safe, or is not recommended at this time.

If no concerns are identified (either in the initial screening, or follow-up questions when potential risks are identified), each questionnaire will lead to a section for Participant Declaration allowing for attestation of questionnaire accuracy, clearing individuals to participate in physical activity, including any physical exertion related to the study/experiment in question.

For additional information about either questionnaire or to check for the most current version of the questionnaires, go to PAR-Q+ or CSEP GAQ.

Though not required, inclusion of either questionnaire into the beginning of studies (following introduction and the informed consent process, prior to experiment start) is strongly recommended for experimental protocols that include physical activity in some form.

Whether a physical activity readiness questionnaire is included, researchers conducting experiments that include physical activity in some form should prepare to respond to possible physical activity related adverse events by adhering to the recommendations shown below.

Preparation in Case of an Adverse Event

Adverse events, such as, but not limited to, fainting, dizziness, nausea, and shortness of breath) can occur following either mild or strenuous physical exertions. The causes of such events are diverse; however, they are most commonly caused by low blood pressure (or more specifically, a rapid/sudden drop in blood pressure during, or following cessation of, physical exertion), or from hypoglycemia (or a rapid/sudden drop in blood sugar). Note that these adverse events can still occur after screening participants and clearing them for physical activity. These events can occur even if no concerns are raised during the screening process.

When possible, it is advisable to build in checks in the study protocol to help identify potential imminent risks of an adverse event occurring, with a plan for intervening and preventing their occurrence. Here are a few recommended checks that can be included in the study.

  • During the informed consent process (or afterwards, when explaining the study protocol/experiment), inform participants to let you (the researcher) know if they are feeling weak and/or faint prior to, during, or immediately following their involvement to the physical intervention. Inform them that you can pause the study at any time to allow them to recover (in addition to having the option of stopping outright and withdrawing from the study). If possible, remind participants to come in well-rested, hydrated and lightly fed before starting the physical activity
  • If the protocol allows for verbal interaction with the participant (i.e. will not affect data quality), check in with the participant before starting the exercise and periodically to ensure they are feeling well and are not feeling weak and/or faint
  • When physical exertion is a planned part of the protocol, build in breaks or rest periods between trials, if possible (i.e. will not affect data quality). Check in with participants after breaks or rest before restarting. Establish a sign that participants may use to indicate that they are not feeling well, e.g. raising their hand
  • Remind participants to bring in medications (e.g. inhaler) where applicable
  • Request emergency contact information (name, phone number) from participants in case they need assistance in getting home after the session
     

If a participant indicates that they are feeling weak, faint, or in physical distress not expected or associated with the physical exertion intervention, it is important for the researcher to remain calm and appropriately intervene as soon as possible. It is recommended to pause or stop the experiment to give the participant the chance to rest/recover and/or indicate they no longer wish to participate.

It is possible that an adverse event may occur without warning (even when checking with participants as explained above). In such an event, it is important for the researcher to remain calm and intervene as soon as possible. First, have a designated area for the participant to sit or lie down. If the participant is feeling faint, you can help guide them into a lying down position; placing something under their feet (e.g. a rolled sweater, towel or small box) to allow their legs to be slightly elevated and help combat fainting. Having water ready and available for participants can also help; sugary beverages such as juice boxes can help raise blood sugar and can combat hypoglycemia.

Reporting Adverse Events

Adverse advents must be reported as follows.

  1. Environmental Health and Safety (EHS): Report incidents, injury and illness to EHS as soon as possible and within 24 hours.  See EHS Report an Incident for detailed instructions and forms
  2. Research Ethics Board: Submit an adverse event report through My Research Human Protocols (MRHP) for the respective ethics protocol, as soon as possible.