| Stage of Pilot study |
Definition |
Example |
| Consideration-of-concept |
Exploring why and how an
intervention might work |
**Develop protocol to prescribe exergaming program (duration and intensity of session)
**Explore usability and accessibility of platform to utilize the exergame
**Identify appropriate safety precautions to take during exergaming |
| Development-of-concept |
Standardizing the new intervention using a randomized control group and masked outcomes |
**Standardizing the prescription of the exergaming protocol
**Testing different exergaming protocols
**Evaluate appropriateness of health outcomes
**Identify potential mechanisms of action
**Feasibility of research protocol (e.g., exploring the appropriateness of inclusion-exclusion criteria) |
| Demonstration-of-concept |
Larger randomized controlled trial to obtain stable effect sizes estimates |
**A randomized controlled pilot trial (15 to 20 subject/group) comparing the efficacy of a standardized traditional exercise program to an exergaming program. |
| Proof-of-concept |
Fully powered randomized controlled trial to generate generalizable data |
**A randomized controlled pilot trial (50 subject/group) comparing the effectiveness of a standardized traditional exercise program to an exergaming program. |
