Physical Activity Behavior Change for Older Adults After Dysvascular Amputation



Status:Active, not recruiting
Conditions:Peripheral Vascular Disease, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:50 - 85
Updated:2/27/2019
Start Date:July 1, 2016
End Date:June 28, 2019

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Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation

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.

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.

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
We found this trial at
1
site
Aurora, Colorado 80045
Principal Investigator: Cory L. Christiansen, PhD
Phone: 303-399-8020
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mi
from
Aurora, CO
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