A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty
| Registry | NCT03708640 |
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, prevention |
| Enrollment | 20 (Actual) |
| Sponsor | Johns Hopkins University (Other); collaborators: National Institute of Allergy and Infectious Diseases (NIAID) |
| Conditions | HIV |
| Interventions | Digital Activity Tracker, Smart Text Messaging, Physical Activity Counseling (Other) |
| Dates | start 2018-11-30, primary completion 2020-03-10, completion 2020-03-10, first posted 2018-10-17, last updated 2022-07-05 |
| Locations | 1 site in United States |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Physical Activity Counseling | Placebo comparator | Other: Physical Activity Counseling | Group receives baseline physical activity counseling.
Group does not receive personalized, health coaching via "smart" text messages. |
| Digital Activity Tracker/Smart Text Messaging | Experimental | Other: Digital Activity Tracker; Other: Smart Text Messaging; Other: Physical Activity Counseling | Group receives baseline physical activity counseling.
Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker. |
- Digital Activity Tracker (Other): Group wears physical activity tracker and receives physical activity feedback information informed by the tracker
- Smart Text Messaging (Other): Group receives personalized, health coaching via "smart" text messages
- Physical Activity Counseling (Other): Group receives baseline counseling on physical activity
+Outcome measures
Primary outcomes
- Change in Mean daily step count [Baseline, 12 weeks]: Mean daily step count will be assessed using a digital physical activity tracker
Secondary outcomes
- 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 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 Physical performance as assessed by the physical performance battery [Baseline, 12 weeks]: Physical performance evaluated with the short physical performance battery
- 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
+Eligibility
Sex: All, ages: 50 Years to any, accepts healthy volunteers
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
+Locations (1)
| Facility | City | Country | Status |
|---|
| Johns Hopkins University | Baltimore, Maryland | United States | |
+Publications
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146. PMID 11253156
+Investigators
+Funding