Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2019-02-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amputation Diabetes Mellitus, Type 2 Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early PABC Intervention

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.

Group Type EXPERIMENTAL

Physical Activity Behavior Change (PABC)

Intervention Type BEHAVIORAL

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.

Physical Activity Behavior Change (PABC)

Intervention Type BEHAVIORAL

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

Wait-List Control Intervention

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.

Group Type EXPERIMENTAL

Physical Activity Behavior Change (PABC)

Intervention Type BEHAVIORAL

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.

Physical Activity Behavior Change (PABC)

Intervention Type BEHAVIORAL

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

Interventions

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Physical Activity Behavior Change (PABC)

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.

Intervention Type BEHAVIORAL

Physical Activity Behavior Change (PABC)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No