Recruiting

Observational Study

Sponsor:

West Park Healthcare Centre

Code:

NCT06667739

Conditions

Amputation

Lower Limb Amputation Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMPACT-L3

Study Details

Brief 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.

Conditions

Amputation

Lower Limb Amputation Knee

Study ID

NCT06667739

Start date

Jan 23, 2025

Status verified date

Feb, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Dysvascular LLA (LLA due to diabetes or vascular disease)
  • major LLA (at the ankle or above)
  • living in the community
  • adult at least 18 years of age
  • comfortable communicating in English and able to understand basic English
  • receptive to using a phone or tablet (e.g., to enable peer coaching, access to modules.

Exclusion Criteria:

  • actively receiving rehabilitation services related to physical activity/mobility
  • recommended medical supervision for physical activity by health care provider, or skin problems preventing usual activity
  • not able to provide informed consent.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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).

Interventions

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.

Primary outcome measure

  • Consent rate: the percent of recruited individuals who provide consent per month. [ Time Frame: 8 weeks ]
  • Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up [ Time Frame: enrollment to 13 weeks ]
  • Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline, end of intervention (week 9) and 4 week follow-up ]
  • Participant processing time: time from initial contact to enrollment. [ Time Frame: 8 weeks ]
  • Intervention fidelity: study-specific checklist outlining key components of the intervention completed by peers. [ Time Frame: enrollment to 8 weeks ]
  • Adverse events: the number of adverse events that occurred during physical activity for the intervention. [ Time Frame: enrollment to 8 weeks ]
  • Usage of web-based module: number of completed modules and number of logins. [ Time Frame: enrollment to 8 weeks ]
  • Participant recruitment rate: the number and proportion of participants recruited per month [ Time Frame: 8 weeks ]
  • Peer recruitment: number of peers recruited [ Time Frame: 2 years ]
  • Participant adherence: the percentage of peer coaching sessions participants attend. [ Time Frame: enrollment to 8 weeks ]
  • The theoretical framework of acceptability (TFA) questionnaire [ Time Frame: week 9 ]

Central Contacts and Locations

Central contacts

Crystal MacKay, PhD, PT

(613) 533-6103crystal.mackay@westpark.org

Locations

West Park Healthcare Centre

Recruiting

Toronto, Ontario, Canada, M6M 2J5

Contacts

Crystal MacKay, PhD

crystal.mackay@westpark.org

More Information

Sponsor

West Park Healthcare Centre

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Keywords

  • Physical activity
  • Behaviour change
  • Peer coaching

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Park Healthcare Centre on 2025-02-24.