Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

Diabetes Mellitus, Type 2 Clinical Trial

— PABC  

Official title:

Physical Activity Behavior Change for Older Veterans After Dysvascular Amputation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02738086
• Other study ID #: F2054-P
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: February 22, 2019

Study information

• Verified date: February 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 22, 2019
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Amputation
• Diabetes Mellitus, Type 2
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rate	Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.	3 months
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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