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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called IMPACT-L3, designed to help individuals who have lost a lower limb due to diabetes become more physically active. The program features virtual coaching by peers who have also experienced limb loss, aiming to improve balance, walking ability, and overall health. Participants will engage in weekly coaching sessions and access online modules about physical activity, supported by an Apple Watch. It suits those who have had a lower limb amputation due to diabetes or vascular disease, live in the community, and are comfortable using technology like a phone or tablet. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for many.

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.

What prior data suggests that the IMPACT-L3 intervention is safe for individuals with lower limb amputation?

Research has shown that the IMPACT-L3 program is a virtual, peer-led method to help individuals with limb loss become more active. The program includes weekly coaching sessions with trained peers who have had similar experiences. Participants set goals and learn about various exercises and their benefits.

Regarding safety, the IMPACT-L3 program has been well-received, with no reports of serious negative effects. Participants use a wearable device, such as an Apple Watch, to track their activities, which is considered safe. Since the program focuses on guidance and motivation rather than medical treatment, it carries minimal risk.

For those considering joining the trial, the goal is to encourage physical activity in a supportive, peer-led environment. Evidence so far suggests it is a safe and positive experience for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IMPACT-L3 program for individuals with lower limb amputation because it introduces a novel approach to rehabilitation through virtual peer health coaching. Unlike traditional physical therapy or prosthetic training, this program leverages the experience of peer trainers who have personally experienced amputation, creating a more relatable and empathetic support system. Participants receive personalized guidance on physical activity and access to web-based educational modules, enhancing their engagement and knowledge. Additionally, the use of an Apple Watch to track physical activity provides real-time feedback, promoting motivation and adherence to the program.

What evidence suggests that IMPACT-L3 is effective for improving physical activity in individuals with lower limb amputation?

Research shows that being active can improve health for people who have lost a leg. In this trial, participants in the IMPACT-L3 arm will receive an online program led by peers to increase physical activity through coaching and technology. Studies indicate that this method can boost motivation and help people become more active. In peer coaching, someone with similar experiences helps participants set goals and create exercise plans. This approach has proven effective in other behavior-change programs, suggesting it could effectively help those with lower limb loss become more active. ^{1 2 3 4 6}

Who Is on the Research Team?

Crystal MacKay, PhD

Principal Investigator

West Park Healthcare Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12244559/

A behaviour change intervention promoting physical activity ... IMPACT-L3 is comprised of these 3 components: Peer health coaching (~30 minutes weekly) will be delivered by a peer trainer over 8 weeks. Peer ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06667739

Study Details | NCT06667739 | Promoting Physical Activity ... Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0326761

A behaviour change intervention promoting physical activity ... We co-created a physical activity intervention, IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3), to support ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06667739?term=AREA%5BBasicSearch%5D(impact%2024)&rank=6

Promoting Physical Activity Following Dysvascular ... Working with individuals with lower limb amputation, we created a virtual, peer-led physical activity behaviour change intervention called IMproving Physical ...

5. journals.plos.org journals.plos.org/plosone/article/asset?unique&id=info:doi/10.1371/journal.pone.0326761.s002

https://journals.plos.org/plosone/article/asset?un... ... health outcomes,53 54 IMPACT-L3 will be delivered entirely virtually. Peer health coaching (~30 minutes weekly) will be delivered by a peer trainer over 8 weeks ...

6. researchgate.net researchgate.net/publication/377124275_Perceptions_of_physical_activity_among_individuals_with_limb_loss_A_qualitative_study

Perceptions of physical activity among individuals with limb ... Participants allocated to the intervention group will receive IMPACT-L3, a physical activity behaviour change intervention which was co-designed ...