Promoting Physical Activity Following Dysvascular Amputation

NCT06667739 | Recruiting

• 1 other identifier: 24-001-WP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Physical activity; Behaviour change; Peer coaching

Outcome Measures

Primary Outcomes (13)

• Consent rate: the percent of recruited individuals who provide consent per month.

  8 weeks

• Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up

  enrollment to 13 weeks

• Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer.

  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.

  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.

  For accelerometers, the percentage of devices that were returned at baseline and follow-up.

  Baseline, end of intervention (week 9) and 4 week follow-up

• Participant processing time: time from initial contact to enrollment.

  8 weeks

• Intervention fidelity: study-specific checklist outlining key components of the intervention completed by peers.

  A subset of peer coaching sessions will be recorded and reviewed by research staff.

  enrollment to 8 weeks

• Adverse events: the number of adverse events that occurred during physical activity for the intervention.

  Adverse events (e.g., falls) will be documented by peers on the standardized form used at each coaching sessions.

  enrollment to 8 weeks

• Usage of web-based module: number of completed modules and number of logins.

  enrollment to 8 weeks

• Participant recruitment rate: the number and proportion of participants recruited per month

  8 weeks

• Peer recruitment: number of peers recruited

  2 years

• Participant adherence: the percentage of peer coaching sessions participants attend.

  enrollment to 8 weeks

• The theoretical framework of acceptability (TFA) questionnaire

  Description: A brief questionnaire developed to assess acceptability in the design, evaluation and implementation of interventions.

  week 9

Secondary Outcomes (11)

• Objective physical activity

  Baseline, week 9, 4 week follow-up

• Self-efficacy for Exercise Scale

  Baseline, week 9, 4 week follow-up

• Self-Regulatory Efficacy for Exercise

  Baseline, week 9, 4 week follow-up

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Baseline, week 9, 4 week follow-up

• The Physical Activity Scale for Individuals with Physical Disability (PASIPD)

  Baseline, week 9, 4 week follow-up

Study Arms (2)

IMPACT-L3

EXPERIMENTAL

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.

Behavioral: IMPACT-L3

Control

NO 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).

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.

IMPACT-L3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Park Healthcare Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Crystal MacKay, PhD

  West Park Healthcare Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal MacKay, PhD, PT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, masking to receipt (or not) of the intervention is impossible. One assessor will collect all data. They will be masked to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study is a parallel group randomized controlled trial with an embedded qualitative component.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: October 31, 2024
• Study Start: January 23, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)