Losing a leg or foot due to complications from diabetes is a leading cause of disability around the world. This experience can negatively affect a person's physical and mental health, as well as their overall quality of life. While physical activity can lower the risk of other long-term diseases and improve quality of life, people who have had a lower limb amputation often have issues with balance and walking, which can lead to a less active lifestyle.
To address this, a physical activity program was created with input from people who have had lower limb amputations. The program is called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). It is designed to help people who have had an amputation due to poor blood circulation to become more physically active. To date, no studies have evaluated a physical activity program for this group that is led by peers, meaning other people who have also experienced a lower limb amputation.
Before a large study can be conducted, a smaller "pilot" study is necessary to test the procedures and improve the design for a future trial. This pilot study will check if the program is practical to run.
The study will randomly assign participants into two separate groups. The study will also include interviews to gather more detailed feedback. For eight weeks, the first group will participate in the new program. This involves weekly online coaching sessions with a peer who is trained in a goal-setting method called brief action planning. This group will also get access to web-based lessons on physical activity and a wearable device that tracks their movement.
The second group, known as the control group, will continue with their standard medical care. At the end of the study period, this group will be offered the opportunity to take part in the new program. Researchers will collect data throughout the study to assess its practicality, looking at the study's processes, resource needs, and management.
The main results being measured are the total amount of physical activity per day, recorded by a wearable monitor, and a person's confidence in their ability to exercise, measured by a questionnaire. These will be measured at the beginning of the study, right after the eight-week program, and again one month later.
Other outcomes will also be measured through questionnaires filled out by the participants. These include self-reported physical activity levels, mobility, depression, social engagement, confidence in their balance, and quality of life.
Researchers will conduct interviews with the participants and the peer coaches to learn about their experiences. These conversations will help determine if the program was practical and if people found it to be a positive experience. The results of this pilot study will provide the information needed to design a larger, more conclusive study to find out if the peer-led physical activity program is effective for people who have had a lower limb amputation because of poor circulation.