OHRP’s “Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) through an Expedited Procedure” lists under (4)(e) “moderate exercise, muscular strength testing, body composition testing, and flexibility testing where appropriate given the age, weight, and health of the individual.”  There is no further detail on how to determine what constitutes moderate exercise (versus vigorous exercise).  This guidance aims to meet that need.

Procedure

The “Expedited or Full Board Review Determination Procedure” described above in this policy will be used to decide whether procedures involving exercise meet the definition above.  However, for protocols falling into ‘gray areas,’ three sources of information will be used at the discretion of the subcommittee: 

1. IRB members or others with expertise in medicine and/or exercise science will be consulted.
2. Subcommittee members will have investigators run them through exercise procedures.

3.    Subcommittee members will consult the guideline below from the Centers for Disease Control and     Prevention and the American College of Sports Medicine (ACSM).

4.    The ACSM table** (p.7) will be considered definitive, if specified parameters are measured in a study of apparently healthy adults, as determined by, for example, the PAR-Q or PAR-Q+

ACSM/CDC Guidelines:

• Moderate exercise consists of activities that result in a noticeable increase in breathing and heart rate, but can be comfortably sustained for ~45 minutes. The activities are commonly described as “very light” to “light” to “somewhat hard” when the level of perceived exertion is rated.  During moderate intensity exercise, participants should be able to easily carry on a conversation.

Examples of common moderate intensity activities include:

• Walking at a moderate or brisk pace on a level surface o Hiking o Water aerobics o Yoga
• Doubles tennis o Raking the lawn o Moderate household cleaning (e.g. vacuuming, washing windows, sweeping).
• More than moderate exercise (vigorous) results in substantial increases in breathing and heart rate. The activities are commonly described as “hard” to “very hard” when the level of perceived exertion is rated. Carrying on a conversation is difficult during/while performing vigorous intensity exercise. Examples of common more than moderate intensity activities include:
  • Jogging or running o      Step aerobics o             Circuit weight training
  • Most competitive sports (basketball, soccer, football, etc.) o Singles tennis o Heavy yard work (e.g. digging ditches, swinging an ax, pushing a mower).
• Note: Moderate intensity activities may, in fact, be more than moderate if the participants are sedentary, not physically fit, elderly, and/or have a known cardiac, pulmonary, or metabolic disease.

Reference:

ACSM's Guidelines for Exercise Testing and Prescription (2010). Baltimore, MD: Lippincott, Williams, & Wilkins.

The IRB thanks Dr. Paul Loprinzi for his efforts in compiling this guidance. (Dr. Loprinzi is an Associate Professor of Health, Exercise Science and Recreation Management, and Director of the Exercise & Memory Laboratory in the School of Applied Sciences.)