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Completed

NCT Number: NCT02738086

Physical Activity Behavior Change for Older Adults 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.

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Key information

Conditions

Amputation Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Peripheral Arterial Disease Peripheral Artery Disease Peripheral Vascular Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

About this study

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:

  • participant retention
  • dose goal attainment
  • participant acceptability
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Activity Behavior Change (PABC)

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.

Primary outcomes

  1. Retention Rate

    Time frame: 3 months

    Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation

Acronym: PABC

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 14, 2016
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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