Promoting Physical Activity Following Dysvascular Amputation

Sponsor
West Park Healthcare Centre
Study ID
NCT06667739
Status
Recruiting
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Conditions

  • Amputation
  • Lower Limb Amputation Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMPACT-L3 — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Oct 31, 2024
Start date
Jan 23, 2025
Status verified
Feb 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: IMPACT-L3
    The experimental group will receive virtual peer health coaching (\~30 minutes weekly) delivered by a peer trainer over 8 weeks. Peer trainers with dysvascular LLA themselves will be matched to a participant based on gender and level of amputation. The peer will help participants set goals and create an action plan for physical activity. Peers will receive specialized training in brief action planning. Participants will have access to five web-based modules. Modules include content on benefits of physical activity, types of physical activity (strengthening, aerobic, balance, flexibility), intensity of activity (light, moderate, vigorous), and exercise safety. Participants will complete modules weekly at their own pace for the first 5 weeks. To support behaviour change, participants will be provided with a wearable to track their physical activity: an Apple Watch to be worn at the wrist of the non-dominant side.
  • No Intervention: Control
    The control group will continue with their usual health care and be offered the intervention program at the end of the follow-up period (wait-list control).

Primary Outcome Measure

Consent rate: the percent of recruited individuals who provide consent per month. [ Time Frame: 8 weeks ]

Central Contacts

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