Physical Activity Behavior Change for Older Adults After Dysvascular Amputation

Not Applicable

Completed

• Conditions: Amputation; Peripheral Artery Disease; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Physical Activity Behavior Change (PABC)

• Registration Number: NCT02738086
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Study Start: 2016-07-01
• Primary Completion: 2019-02-22
• Study Completion: 2019-02-22
• Results First Submitted: 2020-01-10
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Results First Posted: 2020-02-18
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Early PABC Intervention	Physical Activity Behavior Change (PABC)	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.
Wait-List Control Intervention	Physical Activity Behavior Change (PABC)	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.

Primary Outcome Measures

Name	Time	Method
Retention Rate	3 months	Retention rate will be measured as the percent of participants enrolled in the intervention who complete the intervention.
Dose Goal Attainment	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	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	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

Name	Time	Method
Late Life Function and Disability Scale, Limitation	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.
Accelerometer-Based Physical Activity	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	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.

Trial Locations

Locations (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO; 🇺🇸 Aurora, Colorado, United States