From: Pilot and feasibility studies in exercise, physical activity, or rehabilitation research
Population | Intervention | Comparator | Outcome |
---|---|---|---|
 • Balance safety, ability to complete intervention or assess outcomes, and generalizability when selecting inclusion/exclusion criteria  • Willingness to be randomized to the non-exercise group  • How to assess baseline physical activity level and define inclusion/exclusion criteria, e.g., at what frequency, intensity, time, and type to exclude because they are too active | • Participant and instructor fidelity • What type of personnel is required for safe intervention delivery and participant assessment? • Ability and willingness of the participants to understand and adhere to the exercise program • How to measure adherence, especially for unsupervised exercise • Adherence tends to decrease over time—what strategies maximize adherence to intervention? • Exercise setting is accessible, does not create barriers that influence feasibility, and potential generalizability | • Difficult to create a placebo or to blind participants to group allocation • Usual care or attention control group provides equal attention, but because of lack of blinding, may still create challenges with recruitment, retention or potential for bias • Post-randomization drop-out rates may be unequal if control group is dissatisfied | • Emphasis on feasibility objectives and not secondary outcome measures • Must have a priori criteria for success • How to impute missing data if data not missing at random, e.g., drop-out because randomized to control, individuals with impaired mobility may not be able to complete performance based measures at baseline |