Clinical trial NCT02738086: Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
Official title: Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Diabetes Mellitus, Type 2
Peripheral Artery Disease
Keywords: Amputation
Physical Activity
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-04-14
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Retention Rate
timeFrame: 3 months
measure: Dose Goal Attainment
timeFrame: 3 months
measure: Acceptability
timeFrame: 3 months
measure: Study-Related Adverse Events
timeFrame: 3 months
Secondary outcomes:
measure: Accelerometer-Based Physical Activity
timeFrame: 3 months
measure: Late Life Function and Disability Scale, Frequency
timeFrame: 3 months
measure: Accelerometer-Based Physical Activity
timeFrame: 6 months
measure: Late Life Function and Disability Scale, Frequency
timeFrame: 6 months
measure: Late Life Function and Disability Scale, Limitation
timeFrame: 3 months
measure: Late Life Function and Disability Scale, Limitation
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
Study officials:
affiliation: Rocky Mountain Regional VA Medical Center, Aurora, CO
name: Cory L. Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christiansen CL, Miller MJ, Kline PW, Fields TT, Sullivan WJ, Blatchford PJ, Stevens-Lapsley JE. Biobehavioral Intervention Targeting Physical Activity Behavior Change for Older Veterans after Nontraumatic Amputation: A Randomized Controlled Trial. PM R. 2020 Oct;12(10):957-966. doi: 10.1002/pmrj.12374. Epub 2020 May 6.