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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738086
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE April 14, 2016
Results First Submitted Date  ICMJE January 10, 2020
Results First Posted Date  ICMJE February 18, 2020
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date February 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Retention Rate [ Time Frame: 3 months ]
    Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
  • Dose Goal Attainment [ Time Frame: 3 months ]
    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.
  • Acceptability [ Time Frame: 3 months ]
    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.
  • Study-Related Adverse Events [ Time Frame: 3 months ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • Retention Rate [ Time Frame: 3 months ]
    Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
  • Dose Goal Attainment [ Time Frame: 3 months ]
    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.
  • Acceptability [ Time Frame: 3 months ]
    Acceptability will be measured using the mean score of the Intrinsic Motivation Inventory - Interest / Enjoyment Subscale.
  • Study-Related Adverse Events [ Time Frame: 3 months ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2020)
  • Accelerometer-Based Physical Activity [ Time Frame: 3 months ]
    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.
  • Late Life Function and Disability Scale, Frequency [ Time Frame: 3 months ]
    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.
  • Accelerometer-Based Physical Activity [ Time Frame: 6 months ]
    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.
  • Late Life Function and Disability Scale, Frequency [ Time Frame: 6 months ]
    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.
  • Late Life Function and Disability Scale, Limitation [ Time Frame: 3 months ]
    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.
  • Late Life Function and Disability Scale, Limitation [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • Accelerometer-Based Physical Activity [ Time Frame: 3 months ]
    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.
  • Late Life Function and Disability Scale [ Time Frame: 3 months ]
    The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
Official Title  ICMJE Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Amputation
  • Diabetes Mellitus, Type 2
  • Peripheral Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Physical Activity Behavior Change (PABC)
    • Behavioral: Physical Activity Behavior Change (PABC)
  • 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.
    Interventions:
    • Behavioral: Physical Activity Behavior Change (PABC)
    • Behavioral: Physical Activity Behavior Change (PABC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2019)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2016)
32
Actual Study Completion Date  ICMJE February 22, 2019
Actual Primary Completion Date February 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02738086
Other Study ID Numbers  ICMJE F2054-P
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cory L. Christiansen, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO
PRS Account VA Office of Research and Development
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP