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Trial record 10 of 26546 for:    Change | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT02738086
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Amputation Diabetes Mellitus, Type 2 Peripheral Artery Disease Behavioral: Physical Activity Behavior Change (PABC) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation
Actual Study Start Date : July 1, 2016
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine


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: GROUP 2: PABC 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




Primary Outcome Measures :
  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.

  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 Outcome Measures :
  1. Accelerometer-Based Physical Activity [ Time Frame: 3 months, 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.

  2. Late Life Function and Disability Scale [ Time Frame: 3 months, 6 months ]
    The Late Life Function and Disability Scale (LLFDSI) will be used to assess the participant-reported disability at each test point.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738086


Contacts
Contact: Cory L Christiansen, PhD (303) 724-9101 Cory.Christiansen@va.gov
Contact: Jennifer E Stevens-Lapsley, PhD (303) 949-9304 Jennifer.Stevens-Lapsley@va.gov

Locations
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO Recruiting
Denver, Colorado, United States, 80220
Contact: Pamela Rice, PhD    303-399-8020 ext 3846    Pamela.Rice@va.gov   
Contact: Laurie P Grevious    (720) 857-5107    Laurie.Grevious@va.gov   
Principal Investigator: Cory L. Christiansen, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Cory L. Christiansen, PhD VA Eastern Colorado Health Care System, Denver, CO

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02738086     History of Changes
Other Study ID Numbers: F2054-P
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by VA Office of Research and Development:
Amputation
Physical Activity
Rehabilitation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases