Promoting Physical Activity Following Dysvascular Amputation

Condition(s) studied

Investigational drug(s) / intervention(s)

IMPACT-L3: The intervention is a physical activity behaviour change intervention: IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). Two theories provide a framework for IMPACT-L3. One is social cognitive theory and the other is self-determination theory. As mHealth solutions have the potential to increase access and improve health outcomes, IMPACT-L3 will be delivered entirely virtually.

Study summary

Loss of a lower limb due to diabetes can have a devastating impact on physical and mental health and quality of life. Individuals are at risk of other diseases such as cardiovascular disease, loss of the other limb and death. Physical activity can reduce risk of chronic disease and improve health outcomes; however, physical activity levels in people with limb loss are low, often due to reduced balance and walking ability. Rehabilitation services are not readily available and the cost of delivering such programs remains high. Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3). We will conduct a pilot study to assess feasibility and optimize design of a future trial of effectiveness.

Eligibility

Primary outcome measure(s)

• Consent rate: the percent of recruited individuals who provide consent per month. — 8 weeks
• Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up — enrollment to 13 weeks
• Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer. — enrollment to 8 weeks
• Participant and tester burden: the amount of time it took to administer study outcomes at T1, T2, and T3 and the acceptability of the evaluation time commitment from the perspective of participants. — Baseline, end of intervention (week 9) and 4 week follow-up
• Feasibility of data collection: percentage of participants with complete data on each measure at each evaluation time point. — Baseline, end of intervention (week 9) and 4 week follow-up
  For accelerometers, the percentage of devices that were returned at baseline and follow-up.
• Participant processing time: time from initial contact to enrollment. — 8 weeks
• Intervention fidelity: study-specific checklist outlining key components of the intervention completed by peers. — enrollment to 8 weeks
  A subset of peer coaching sessions will be recorded and reviewed by research staff.
• Adverse events: the number of adverse events that occurred during physical activity for the intervention. — enrollment to 8 weeks
  Adverse events (e.g., falls) will be documented by peers on the standardized form used at each coaching sessions.
• Usage of web-based module: number of completed modules and number of logins. — enrollment to 8 weeks
• Participant recruitment rate: the number and proportion of participants recruited per month — 8 weeks
• Peer recruitment: number of peers recruited — 2 years
• Participant adherence: the percentage of peer coaching sessions participants attend. — enrollment to 8 weeks
• The theoretical framework of acceptability (TFA) questionnaire — week 9
  Description: A brief questionnaire developed to assess acceptability in the design, evaluation and implementation of interventions.

Trial sites (1)

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