N/A
Completed N=31
Physical Activity Behavior Change for Older Adults After Dysvascular Amputation
Amputation · Type 2 Diabetes Mellitus · Peripheral Artery Disease
Source: ClinicalTrials.gov NCT02738086 ↗
Enrolled (actual)
31
Serious AEs
6.5%
Results posted
Feb 2020
Primary outcomePrimary: Retention Rate — 14; 13 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention Rate |
14; 13 | — |
| PRIMARY Dose Goal Attainment |
3 | — |
| PRIMARY Acceptability |
5.8 | — |
| PRIMARY Study-Related Adverse Events |
20; 29 | — |
| SECONDARY Accelerometer-Based Physical Activity |
1716; 1773 | — |
| SECONDARY Late Life Function and Disability Scale, Frequency |
52.5; 51.3 | — |
| SECONDARY Late Life Function and Disability Scale, Limitation |
74.3; 68.6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02738086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.