Physical Activity Behavior Change for Older Adults After Dysvascular Amputation (PABC)

VA Office of Research and Development

Status: Completed

Conditions: Peripheral Artery Disease; Amputation; Diabetes Mellitus, Type 2

Treatments: Behavioral: Physical Activity Behavior Change (PABC)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02738086

F2054-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

31 participants in 2 patient groups

Early PABC Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Behavior Change (PABC)

Behavioral: Physical Activity Behavior Change (PABC)

Wait-List Control Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical Activity Behavior Change (PABC)

Behavioral: Physical Activity Behavior Change (PABC)