Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

Study Overview
=================
Brief Summary
-----------------
This pilot study will use mobile-health technology to deliver an intervention designed for lasting physical activity behavior change. The study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with lower limb amputation. This intervention will be delivered using wrist-worn wearable activity sensors and a home-based tablet computer to allow real-time physical activity feedback and video interface between the participants and the therapist.

Detailed Description
-----------------
This pilot study will assess the feasibility of using the Physical Activity Behavior Change(PABC) intervention for Veterans with dysvascular lower limb amputation. In addition, preliminary efficacy of the PABC intervention will be assessed using a two-group randomized cross-over design. Testing will occur at baseline (pre-intervention), three months (end of intervention), and six months. The primary aim is to determine feasibility of using the PABC intervention with Veterans who have dysvascular amputation by measuring: participant retention dose goal attainment participant acceptability safety The secondary aim is to preliminary assess efficacy of the PABC intervention by measuring accelerometer-based physical activity and self-report disability effect sizes.

Official Title
-----------------
Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation

Conditions
-----------------
Amputation, Diabetes Mellitus, Type 2, Peripheral Artery Disease

Intervention / Treatment
-----------------
* Behavioral: Physical Activity Behavior Change (PABC)
* Behavioral: Physical Activity Behavior Change (PABC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lower limb amputation 1-5 years prior to enrollment Type 2 Diabetes Mellitus and/or Peripheral Artery Disease Ambulatory using a lower limb prosthesis English speaking Exclusion Criteria: Traumatic or cancer-related etiology of the lower limb amputation Unstable heart condition, including: unstable angina uncontrolled cardiac dysrhythmia acute myocarditis acute pericarditis Uncontrolled hypertension Acute systemic infection Prisoner Decisionally challenged volunteers Cancer Recent cerebral vascular accident (within two years) lower extremity wound or ulcer that limits ability to ambulate

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early PABC Intervention<br>GROUP 1 will participate in the Physical Activity Behavior Change (PABC) intervention phase during the first 3 months. GROUP 1 will then participate in a non-exercise control phase during the second 3 months. | Behavioral: Physical Activity Behavior Change (PABC)<br>* Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.<br>Behavioral: Physical Activity Behavior Change (PABC)<br>* Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning<br>|
| Experimental: Wait-List Control Intervention<br>GROUP 2 will participate in a non-exercise control phase during the first 3 months. GROUP 2 will then participate in the Physical Activity Behavior Change (PABC) intervention phase in the second 3 months. | Behavioral: Physical Activity Behavior Change (PABC)<br>* Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.<br>Behavioral: Physical Activity Behavior Change (PABC)<br>* Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention Rate | Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention. | 3 months | 
| Dose Goal Attainment | Dose goal attainment will be measured as the percent of participants in the intervention phase of the study who meet the dose goal of an average 3% increase in daily steps. | 3 months | 
| Acceptability | Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale. The scores range from 1 to 7, with higher numbers indicating higher acceptability, and a null value of 5.0. | 3 months | 
| Study-Related Adverse Events | Safety will be assessed as differences in rates of study-related adverse events between GROUP 1 and GROUP 2 during the first three months, when GROUP 1 is in the intervention phase and GROUP 2 is in the non-intervention control phase. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accelerometer-Based Physical Activity | Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts. | 3 months | 
| Late Life Function and Disability Scale, Frequency | The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability. | 3 months | 
| Accelerometer-Based Physical Activity | Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts. | 6 months | 
| Late Life Function and Disability Scale, Frequency | The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability. | 6 months | 
| Late Life Function and Disability Scale, Limitation | The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability. | 3 months | 
| Late Life Function and Disability Scale, Limitation | The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amputation, Physical Activity, Rehabilitation