IMPACT-L3 for Amputation

Overseen By Crystal MacKay, PhD, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Park Healthcare Centre

Disqualifiers: Rehabilitation, Medical supervision, Skin problems

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Research Team

Crystal MacKay, PhD

Principal Investigator

West Park Healthcare Centre

Eligibility Criteria

This trial is for individuals who have lost a lower limb, specifically below the knee, due to diabetes-related complications. It aims to help those struggling with physical activity post-amputation. Participants should be interested in a virtual program designed to improve their physical activity through coaching and technology.

Inclusion Criteria

Living in the community

Receptive to using a phone or tablet (e.g., to enable peer coaching, access to modules)

I have had a major leg amputation at or above the ankle.

Exclusion Criteria

I am unable to understand or sign the consent form.

I am currently in physical therapy for mobility.

I need a doctor's supervision for exercise or have skin issues limiting my activity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive virtual peer health coaching and access to web-based physical activity modules for 8 weeks

8 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• IMPACT-L3

Trial Overview The intervention being tested is called IMPACT-L3, which stands for IMproving Physical Activity through Coaching and Technology following Lower Limb Loss. This pilot study will evaluate the feasibility of this virtual peer-led program that encourages increased physical activity among amputees.

Participant Groups

Group I: IMPACT-L3 Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

West Park Healthcare Centre

Lead Sponsor

Trials

36

Recruited

2,400+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+