HIV
Conditions
Keywords
Frailty, Physical Activity, HIV, Aging, Exercise, mHealth, smartphone, activity tracker, pedometer, text messaging, Short Message Service (SMS)
Brief summary
This pilot study will examine the effect of a mobile health text messaging platform linked to a digital physical activity tracker on physical activity among persons living with HIV and frailty.
Detailed description
HIV is associated with frailty, an important aging-related phenotype associated with adverse clinical outcomes. The investigators propose that personalized health coaching using a digital activity tracker with mobile health text messaging can increase physical activity in this population. The total duration of the intervention will be 12 weeks.
Interventions
Group wears physical activity tracker and receives physical activity feedback information informed by the tracker
OTHERSmart Text Messaging
Group receives personalized, health coaching via smart text messages
OTHERPhysical Activity Counseling
Group receives baseline counseling on physical activity
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* HIV-1 positive adults of any gender * Age 50 years and older * Frailty score of 2 or greater (at least 1 criteria is slow gait speed or decreased grip strength) * Ability to provide informed consent
Exclusion criteria
* Any physical condition that would prevent or prohibit moderate physical activity * \>3 days per week of moderate or vigorous leisure time activity lasting \>30 min/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean daily step count | Baseline, 12 weeks | Mean daily step count will be assessed using a digital physical activity tracker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Fitness as assessed by 12 minute walk | Baseline, 12 weeks | Physical fitness of participants will be assessed by the ability to do a 12 minute walk |
| Change in Muscle strength as assessed by isokinetic resistance | Baseline, 12 weeks | Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs) |
| Percent change in fat mass | Baseline, 12 weeks | Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan |
| Percent change in lean mass | Baseline, 12 weeks | Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan |
| Change in Frailty as assessed by the Fried-based physical frailty phenotype | Baseline, 12 weeks | Frailty evaluated based on the standard 5 point Fried-based frailty phenotype construct (slow gait, weakness, weight loss, exhaustion, low physical activity) |
| Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV) | Baseline, 12 weeks | The Medical Outcomes Study HIV Health Survey (MOS-HIV) is a brief, comprehensive measure of health-related quality of life. The 35-item questionnaire includes 10 dimensions (pain, physical, role, health perceptions, social and cognitive functioning, energy, mental health, health distress and quality of life). Each dimension is scored on a 0-100 scale (a higher score indicates better health related quality of life). An overall score is obtained through a summation of z scores from each domain. |
| Change in Interleukin-6 (IL-6) concentration | Baseline, 12 weeks | Interleukin-6 concentration in pg/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change |
| Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) | Baseline, 12 weeks | sTNFR1 concentration in ng/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change |
| Change in Physical performance as assessed by the physical performance battery | Baseline, 12 weeks | Physical performance evaluated with the short physical performance battery |
Countries
United States
Outcome results
None listed