Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
PABC
1 other identifier
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 22, 2019
CompletedResults Posted
Study results publicly available
February 18, 2020
CompletedFebruary 18, 2020
February 1, 2020
2.6 years
March 16, 2016
January 10, 2020
February 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (6)
Accelerometer-Based Physical Activity
3 months
Late Life Function and Disability Scale, Frequency
3 months
Accelerometer-Based Physical Activity
6 months
Late Life Function and Disability Scale, Frequency
6 months
Late Life Function and Disability Scale, Limitation
3 months
- +1 more secondary outcomes
Study Arms (2)
Early PABC Intervention
EXPERIMENTALGROUP 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.
Wait-List Control Intervention
EXPERIMENTALGROUP 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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045, United States
Related Publications (1)
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.
PMID: 32248638DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cory L. Christiansen
- Organization
- University of Colorado Denver
Study Officials
- PRINCIPAL INVESTIGATOR
Cory L. Christiansen, PhD
Rocky Mountain Regional VA Medical Center, Aurora, CO
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2016
First Posted
April 14, 2016
Study Start
July 1, 2016
Primary Completion
February 22, 2019
Study Completion
February 22, 2019
Last Updated
February 18, 2020
Results First Posted
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share