Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Amputation
- Sponsor
- VA Office of Research and Development
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Retention Rate
- Status
- Completed
- Last Updated
- 6 years ago
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: 1. participant retention 2. dose goal attainment 3. participant acceptability 4. 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.
Investigators
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
- •Decisionally challenged volunteers
- •Recent cerebral vascular accident (within two years)
Outcomes
Primary Outcomes
Retention Rate
Time Frame: 3 months
Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Dose Goal Attainment
Time Frame: 3 months
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.
Acceptability
Time Frame: 3 months
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.
Study-Related Adverse Events
Time Frame: 3 months
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.
Secondary Outcomes
- Accelerometer-Based Physical Activity(6 months)
- Late Life Function and Disability Scale, Frequency(6 months)
- Late Life Function and Disability Scale, Limitation(6 months)