Actively Recruiting
A Behaviour Change Intervention Promoting Physical Activity Following Dysvascular Amputation: a Pilot Study
Led by West Park Healthcare Centre · Updated on 2025-02-24
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
West Park Healthcare Centre
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Diabetes-related lower limb amputation (LLA) causes significant challenges for physical and mental health, including increased risk of cardiovascular disease, amputation in the other limb, and a higher chance of death. People with dysvascular LLA often experience reduced balance, walking ability, and strength, leading to low physical activity levels. Rehabilitation services are limited and costly, so this study is evaluating a virtual, peer-led physical activity intervention called IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3) to support behavior change and improve health outcomes in this population. This pilot study aims to assess the feasibility of conducting a larger trial to test the intervention's effectiveness. Participants will be randomly assigned to either the experimental group or the control group. The experimental group will receive weekly virtual peer coaching sessions for about 30 minutes over 8 weeks, with peers matched by gender and level of amputation. They will also access five web-based physical activity modules covering benefits, types, intensity, and safety of exercise, completed at their own pace during the first five weeks. Additionally, participants will wear an Apple Watch on their non-dominant wrist to monitor physical activity. The control group will continue their usual healthcare and be offered the intervention after the follow-up period. Throughout the study, participants will be assessed at baseline, after the intervention (week 9), and at a 4-week follow-up. Researchers will collect data on physical activity levels using an ActiGraph activity monitor and measure participants' confidence in exercising using the Self-efficacy for Exercise scale. Other assessments include surveys on depression, balance confidence, prosthesis use, and quality of life. Study feasibility will be evaluated by tracking consent and withdrawal rates, adherence to coaching sessions, time needed for assessments, data completeness, and participant feedback through interviews. The total participation spans approximately 13 weeks, including follow-up.
CONDITIONS
Brief Title
Promoting Physical Activity Following Dysvascular Amputation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Dysvascular lower limb amputation (due to diabetes or vascular disease)
- Major lower limb amputation at the ankle or above
- Living in the community
- Adults aged 18 years or older
- Comfortable communicating in English and able to understand basic English
- Willing and able to use a phone or tablet to access peer coaching and modules
You will not qualify if you...
- Currently receiving rehabilitation services related to physical activity or mobility
- Medical advice requiring supervision for physical activity or skin problems preventing usual activity
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual or in-person) for screening and enrollment
Duration - 8 weeks
Participants in the intervention group receive a virtual peer-led physical activity behaviour change program including weekly peer coaching sessions, access to web-based modules, and use of a wearable activity monitor for 8 weeks. The control group continues with usual healthcare.
Weekly virtual peer coaching sessions and self-paced completion of web-based modules over 5 weeks
Duration - 4 weeks
Participants are assessed for physical activity levels, self-efficacy, and other health outcomes 4 weeks after completing the intervention or control period.
1 follow-up assessment visit (virtual or in-person)
Trial Site Locations
Total: 1 location
1
West Park Healthcare Centre
Toronto, Ontario, Canada, M6M 2J5
Actively Recruiting
Research Team
C
Crystal MacKay, PhD, PT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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