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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Amputation; Peripheral Artery Disease
• Intervention / Treatment: Behavioral: Physical Activity Behavior Change (PABC); Behavioral: Physical Activity Behavior Change (PABC)

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Rocky Mountain Regional VA Medical Center, Aurora, CO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; 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
Experimental: 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.	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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Rate	Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.	3 months
Dose Goal Attainment	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.	3 months
Acceptability	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.	3 months
Study-Related Adverse Events	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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometer-Based Physical Activity	Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.	3 months
Late Life Function and Disability Scale, Frequency	The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.	3 months
Accelerometer-Based Physical Activity	Physical activity counts will be measured using a waist-mounted accelerometer-based physical activity monitor (Actigraph). The outcome will be average daily physical activity counts.	6 months
Late Life Function and Disability Scale, Frequency	The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.	6 months
Late Life Function and Disability Scale, Limitation	The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.	3 months
Late Life Function and Disability Scale, Limitation	The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point. Scores range from 0 to 100, with higher scores indicating higher disability.	6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): February 22, 2019
• Study Completion (Actual): February 22, 2019

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical Activity; Amputation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Diabetes Mellitus; Atherosclerosis; Peripheral Vascular Diseases; Diabetes Mellitus, Type 2; Peripheral Arterial Disease
• Other Study ID Numbers: F2054-P

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No