Feasibility indicators and measurement criteria.

Background
Diabetes-related lower limb amputation (LLA) is a leading cause of disability globally, impacting individuals’ physical and mental health, and ultimately their quality of life. Physical activity can reduce risk of chronic disease and mortality while improving quality of life. However, people with LLA often have reduced balance and walking ability resulting in sedentary behaviour. We co-created a physical activity intervention, IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3), to support physical activity behaviour change in people with dysvasular LLA. To date, no studies have assessed a peer-led physical activity behaviour change intervention for people with LLA. Prior to launching a large trial, a pilot study is required to assess feasibility and optimize design of a future trial.
Methods
This pilot study is a parallel group randomized controlled trial (RCT) with an embedded qualitative component. The intervention group will have access to once-weekly virtual peer coaching sessions with a peer trained in brief action planning; web-based physical activity modules; and a wearable activity monitor for 8 weeks. The control group will continue usual care and be offered the intervention at the end of the follow-up period. Data on feasibility will be collected including assessment of process, resource, management and treatment indicators. The proposed primary outcomes will be measured at baseline, post-intervention and one month later: total physical activity counts per day measured by the ActiGraphTM activity monitor and self-efficacy measured by the Self-efficacy for Exercise scale. Secondary measures include patient reported outcome measures of physical activity, mobility, depression, social participation, balance confidence and quality of life. Semi-structured interviews will explore feasibility and acceptability of the intervention to participants and peers.
Discussion
This study will inform the design of a definitive RCT to determine the effectiveness of a peer-led physical activity intervention for people with dysvascular LLA.