A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty

Johns Hopkins University1 site in 1 country20 target enrollmentNovember 30, 2018

ConditionsHIV

Overview

Phase: N/A
Intervention: Not specified
Conditions: HIV
Sponsor: Johns Hopkins University
Enrollment: 20
Locations: 1
Primary Endpoint: Change in Mean daily step count
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 30, 2018

End Date

March 10, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change in Mean daily step count

Time Frame: 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)
Percent change in lean mass(Baseline, 12 weeks)
Change in Muscle strength as assessed by isokinetic resistance(Baseline, 12 weeks)
Percent change in fat mass(Baseline, 12 weeks)
Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1)(Baseline, 12 weeks)
Change in Physical Fitness as assessed by 12 minute walk(Baseline, 12 weeks)
Change in Interleukin-6 (IL-6) concentration(Baseline, 12 weeks)
Change in Physical performance as assessed by the physical performance battery(Baseline, 12 weeks)
Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV)(Baseline, 12 weeks)