Clinical trial NCT06667739: Promoting Physical Activity Following Dysvascular Amputation
Official title: A Behaviour Change Intervention Promoting Physical Activity Following Dysvascular Amputation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Lower Limb Amputation Knee
Keywords: Physical activity
Behaviour change
Peer coaching
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study is a parallel group randomized controlled trial with an embedded qualitative component.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Consent rate: the percent of recruited individuals who provide consent per month.
timeFrame: 8 weeks
measure: Withdrawal Rate: the percent of study participants withdrawing by 9 weeks and 4 week follow-up
timeFrame: enrollment to 13 weeks
measure: Peer coach adherence: total number of peer coaching sessions attended by the peer-trainer.
timeFrame: enrollment to 8 weeks
measure: 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.
timeFrame: Baseline, end of intervention (week 9) and 4 week follow-up
measure: Feasibility of data collection: percentage of participants with complete data on each measure at each evaluation time point.
timeFrame: Baseline, end of intervention (week 9) and 4 week follow-up
measure: Participant processing time: time from initial contact to enrollment.
timeFrame: 8 weeks
measure: Intervention fidelity: study-specific checklist outlining key components of the intervention completed by peers.
timeFrame: enrollment to 8 weeks
measure: Adverse events: the number of adverse events that occurred during physical activity for the intervention.
timeFrame: enrollment to 8 weeks
measure: Usage of web-based module: number of completed modules and number of logins.
timeFrame: enrollment to 8 weeks
measure: Participant recruitment rate: the number and proportion of participants recruited per month
timeFrame: 8 weeks
measure: Peer recruitment: number of peers recruited
timeFrame: 2 years
measure: Participant adherence: the percentage of peer coaching sessions participants attend.
timeFrame: enrollment to 8 weeks
measure: The theoretical framework of acceptability (TFA) questionnaire
timeFrame: week 9
Secondary outcomes:
measure: Objective physical activity
timeFrame: Baseline, week 9, 4 week follow-up
measure: Self-efficacy for Exercise Scale
timeFrame: Baseline, week 9, 4 week follow-up
measure: Self-Regulatory Efficacy for Exercise
timeFrame: Baseline, week 9, 4 week follow-up
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline, week 9, 4 week follow-up
measure: The Physical Activity Scale for Individuals with Physical Disability (PASIPD)
timeFrame: Baseline, week 9, 4 week follow-up
measure: Leisure-Time Physical Activity for People with Disabilities Questionnaire (LTPAQ-D)
timeFrame: Baseline, week 9, 4 week follow-up
measure: Activities-specific Balance Confidence scale (ABC)
timeFrame: Baseline, week 9, 4 week follow-up
measure: Prosthesis Evaluation Questionnaire - Mobility Section (PEQ-MS)
timeFrame: Baseline, week 9, 4 week follow-up
measure: Short Form Health Survey 12 Item survey (SF-12)
timeFrame: Baseline, week 9, 4 week follow-up
measure: Frenchay Activities Index (FAI)
timeFrame: Baseline, week 9, 4 week follow-up
measure: Self Efficacy for Exercise: Dysvascular Lower Limb Amputees
timeFrame: Baseline, week 9, 4 week follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: West Park Healthcare Centre
name: Crystal MacKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: