Promoting Physical Activity Following Dysvascular Amputation

NCT ID: NCT06667739

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-23
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Amputation; Lower Limb Amputation Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

IMPACT-L3

Intervention Type: 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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

West Park Healthcare Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Crystal MacKay, PhD

Role: PRINCIPAL_INVESTIGATOR

West Park Healthcare Centre

Locations

West Park Healthcare Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Crystal MacKay, PhD, PT

Role: CONTACT

crystal.mackay@westpark.org

(613) 533-6103

Facility Contacts

Crystal MacKay, PhD

Role: primary

crystal.mackay@westpark.org

Other Identifiers

24-001-WP

Identifier Type: -

Identifier Source: org_study_id