mHealth Physical Activity Trial for Older HIV-infected Adults (mFIT)

Not Applicable

Completed

• Conditions: HIV
• Interventions: Other: Physical Activity Counseling; Other: Digital Activity Tracker; Other: Smart Text Messaging

• Registration Number: NCT03708640
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-15
• Study First Posted: 2018-10-17
• Study Start: 2018-11-30
• Primary Completion: 2020-03-10
• Study Completion: 2020-03-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Counseling	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	Digital Activity Tracker	Group receives baseline physical activity counseling. Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker.
Digital Activity Tracker/Smart Text Messaging	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/Smart Text Messaging	Smart Text Messaging	Group receives baseline physical activity counseling. Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker.

Primary Outcome Measures

Name	Time	Method
Change in Mean daily step count	Baseline, 12 weeks	Mean daily step count will be assessed using a digital physical activity tracker

Secondary Outcome Measures

Name	Time	Method
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)
Percent change in lean mass	Baseline, 12 weeks	Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan
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
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 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 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 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.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States