Promoting Physical Activity Following Dysvascular Amputation

A Behaviour Change Intervention Promoting Physical Activity Following Dysvascular Amputation: a Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation; Lower Limb Amputation Knee
• Intervention / Treatment: Behavioral: IMPACT-L3

Detailed Description

Background and Importance: Diabetes-related lower limb amputation (LLA) is a leading cause of disability globally, impacting individuals' physical and mental health and ultimately their quality of life. Individuals with LLA due to diabetes or other vascular disease (dysvascular LLA) often have comorbidities, including higher rates of cardiovascular disease than the general population. They are at risk of amputation in the contralateral limb and have high mortality rates (30% at one year).

There is strong evidence demonstrating that physical activity reduces risk of chronic disease and mortality and improves quality of life. However, people with dysvascular LLA often have reduced strength, balance, walking ability and increased energy expenditure during ambulation. Consequently, they have impaired mobility that can lead to sedentary behaviour. Across studies examining physical activity in people with dysvascular LLA, step counts ranged from 1250 steps/day in older prosthesis users to 3809±2189 steps/day in people with diabetes-related LLA. Unfortunately, limited availability of rehabilitation services for people with LLA and the high cost of delivering healthcare interventions makes provision of support for physical activity challenging. To address this gap, we co-created a physical activity intervention, IMproving Physical Activity through Coaching and Technology following Lower Limb Loss (IMPACT-L3), to support physical activity behaviour change in people with dysvascular LLA. Prior to launching a large trial, a pilot study is required to assess feasibility and optimize design of a future trial. This study aims to assess the feasibility of conducting a definitive randomized controlled trial (RCT) to determine the effectiveness of a virtual peer-led physical activity intervention on levels of physical activity and self-efficacy in people with dysvascular LLA. Specific objectives are to: 1) evaluate feasibility according to indicators of process, resources, management and treatment; 2) explore perceptions of program characteristics, program implementation and study procedures among individuals with LLA; 3) explore the perceived feasibility and acceptability of the program among peer coaches; and 4) inform a sample size calculation for a future trial of effectiveness.

Methods: This pilot study is a parallel group RCT with an embedded qualitative component. The intervention group will have access to once-weekly virtual peer coaching sessions with a gender and level of amputation-matched peer trained in brief action planning; web-based physical activity modules; and a wearable activity monitor for 8 weeks. The control group will continue their usual health care and be offered the intervention at the end of the follow-up period. Data on feasibility of implementing the intervention and conducting the trial will be collected including assessment of process, resource, management and treatment indicators. Progression Criteria: A traffic light approach (red, amber, green) will be used to guide the research team in determining what changes may be required to address identified challenges based on the indicators and in determining the feasibility of progression to a trial. The proposed primary outcomes for a future trial will be measured at baseline, post intervention (week 9) and 4 week follow-up: total physical activity counts per day measured by the ActiGraphTM activity monitor and self-efficacy measured by the Self-efficacy for Exercise scale. Other outcome measures include: the Physical Activity Scale for Individuals with Physical Disability, Frenchay Activity Index, the Center for Epidemiologic Studies Depression Scale, Activities-specific Balance Confidence scale, Prosthesis Evaluation Questionnaire - Mobility Section, and Short Form Health Survey 12 Item survey. Semi-structured interviews will explore feasibility and acceptability of the intervention to participants (~15-20 participants) and peers. Inductive thematic analysis will be employed to analyze qualitative interviews.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Crystal MacKay, PhD, PT; Phone Number: (613) 533-6103; Email: crystal.mackay@westpark.org

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6M 2J5
      • Recruiting
      • West Park Healthcare Centre
      • Contact: Crystal MacKay, PhD; Email: crystal.mackay@westpark.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective physical activity	A tri-axial accelerometer is a lightweight device used to measure total activity counts. The sum of the total count for the day will be used and averaged over the measurement period.	Baseline, week 9, 4 week follow-up
Self-efficacy for Exercise Scale	A self-report measure (9 items) that includes situations that may influence physical activity participation. Participants will respond to each item on a 0 (not very confident) to 10 (very confident) scale.	Baseline, week 9, 4 week follow-up
Self-Regulatory Efficacy for Exercise	8-item measure to assess participants' confidence in their ability to manage their exercise.	Baseline, week 9, 4 week follow-up
Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D will assess participant's self-rated depressive symptoms. It is a 20-item scale that refers to symptoms in the last week.	Baseline, week 9, 4 week follow-up
The Physical Activity Scale for Individuals with Physical Disability (PASIPD)	The PASIPD is a 13-item questionnaire with subscales measuring leisure time, household and work-related activities.	Baseline, week 9, 4 week follow-up
Leisure-Time Physical Activity for People with Disabilities Questionnaire (LTPAQ-D)	The LTPAQ-D is a self-report measure that assesses minutes of mild-, moderate-, and vigorous-intensity leisure time physical activity (i.e., activity that requires physical exertion and that one chooses to do in their free time performed over the past 7 days.	Baseline, week 9, 4 week follow-up
Activities-specific Balance Confidence scale (ABC)	ABC is a self-report measure used to assess perceived balance confidence.	Baseline, week 9, 4 week follow-up
Prosthesis Evaluation Questionnaire - Mobility Section (PEQ-MS)	The PEQ-MS score will be used to measure the amount of difficulty completing locomotion tasks.	Baseline, week 9, 4 week follow-up
Short Form Health Survey 12 Item survey (SF-12)	The SF-12 will be used to measure health related quality of life.	Baseline, week 9, 4 week follow-up
Frenchay Activities Index (FAI)	The 15-item FAI captures information on social activities. The items reflect the frequency of performance of basic and instrumental activities of daily living over three domains.	Baseline, week 9, 4 week follow-up
Self Efficacy for Exercise: Dysvascular Lower Limb Amputees	4-item measure will be administered in addition the standardized self-efficacy for exercise measure and self-regulatory efficacy for exercise measure to address contextual factors relevant to dysvascular lower limb amputees.	Baseline, week 9, 4 week follow-up

Collaborators and Investigators

• Sponsor: West Park Healthcare Centre
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Crystal MacKay, PhD, West Park Healthcare Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Behaviour change; Peer coaching
• Other Study ID Numbers: 24-001-WP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No