Clinical trial NCT03708640: mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)
Official title: A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Frailty
Physical Activity
HIV
Aging
Exercise
mHealth
smartphone
activity tracker
pedometer
text messaging
Short Message Service (SMS)
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2018-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean daily step count
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in Frailty as assessed by the Fried-based physical frailty phenotype
timeFrame: Baseline, 12 weeks
measure: Change in Physical Fitness as assessed by 12 minute walk
timeFrame: Baseline, 12 weeks
measure: Change in Muscle strength as assessed by isokinetic resistance
timeFrame: Baseline, 12 weeks
measure: Percent change in fat mass
timeFrame: Baseline, 12 weeks
measure: Percent change in lean mass
timeFrame: Baseline, 12 weeks
measure: Change in Physical performance as assessed by the physical performance battery
timeFrame: Baseline, 12 weeks
measure: Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)
timeFrame: Baseline, 12 weeks
measure: Change in Interleukin-6 (IL-6) concentration
timeFrame: Baseline, 12 weeks
measure: Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Damani Piggott, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.