HIV Infections
Conditions
Keywords
peripheral neuropathy, pain, function
Brief summary
Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).
Detailed description
The overall goal of this study is to explore the impact of HIV-associated distal sensory polyneuropathy on physical performance, physical activity, and pain pressure threshold. The aim is to determine if the presence of painful distal sensory polyneuropathy in the feet adversely affects physical performance, physical activity, and pain pressure threshold in PLHIV.
Interventions
OTHERNo intervention
No intervention. Study is cross-sectional observational.
Sponsors
Thomas Jefferson University
Rutgers, The State University of New Jersey
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of HIV infection currently treated with antiretroviral therapy (ART) * cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3 * 18-64 years of age * able to read and write in English * means to travel to a study site * Additional inclusion for cohort with painful neuropathy in the feet: * presence of peripheral neuropathy symptoms in feet * average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale * pain in the feet present for at least the past 3 months * no changes in medications used to manage pain in the past 4 weeks
Exclusion criteria
* current opportunistic infection(s) * cluster of differentiation 4 cell (CD4 cell) count \<200 cells/mm3 * dementia * uncontrolled psychiatric disorder * wounds or sores on the feet * musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Performance | Week 0 (one-time) | Physical performance score generated via the Short Physical Performance Battery. (SPPB). SPPB procedures generate a total score reflective of physical performance. Minimum score=0; maximum score=12; lower score=worse outcome |
| Gait - Step Time | Week 0 (one-time) | Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway |
| Gait - Stride Width | Week 0 (one-time) | Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway |
| Gait - Cadence | Week 0 (one-time) | Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway |
| Gait - Foot Fall Area | Week 0 (one-time) | Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway |
| Gait - Walking velocity | Week 0 (one-time) | Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway |
| Gait - Step Length | Week 0 (one-time) | Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whole Body Strength | Week 0 (one-time) | Mid-thigh pull test will be used to generate a score expressed as force in pounds or kilograms that is reflective of whole body strength. |
| Pain pressure threshold | Week 0 (one-time) | Pain pressure threshold (expressed in pounds or kilograms of force) at lower extremity landmarks via use of a digital algometer |
| Physical Activity | 5 days from date of all other outcomes | Physical activity characteristics: (1) over a span of 5 days captured via a wrist-band style Actigraph activity monitor; (2) self-reported physical activity over past 7 days using International Physical Activity Questionnaire - Short Form |
| Walking Endurance | Week 0 (one-time) | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). |
Countries
United States
Outcome results
None listed