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

Study 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.

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

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Other: Digital Activity Tracker
* Other: Smart Text Messaging
* Other: Physical Activity Counseling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Physical Activity Counseling<br>Group receives baseline physical activity counseling. Group does not receive personalized, health coaching via smart text messages. | Other: Physical Activity Counseling<br>* Group receives baseline counseling on physical activity<br>|
| Experimental: Digital Activity Tracker/Smart Text Messaging<br>Group receives baseline physical activity counseling. Group receives personalized, health coaching via smart text messages informed by digital activity tracker. | Other: Digital Activity Tracker<br>* Group wears physical activity tracker and receives physical activity feedback information informed by the tracker<br>Other: Smart Text Messaging<br>* Group receives personalized, health coaching via smart text messages<br>Other: Physical Activity Counseling<br>* Group receives baseline counseling on physical activity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean daily step count | Mean daily step count will be assessed using a digital physical activity tracker | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Frailty as assessed by the Fried-based physical frailty phenotype | Frailty evaluated based on the standard 5 point Fried-based frailty phenotype construct (slow gait, weakness, weight loss, exhaustion, low physical activity) | Baseline, 12 weeks | 
| Change in Physical Fitness as assessed by 12 minute walk | Physical fitness of participants will be assessed by the ability to do a 12 minute walk | Baseline, 12 weeks | 
| Change in Muscle strength as assessed by isokinetic resistance | Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs) | Baseline, 12 weeks | 
| Percent change in fat mass | Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan | Baseline, 12 weeks | 
| Percent change in lean mass | Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan | Baseline, 12 weeks | 
| Change in Physical performance as assessed by the physical performance battery | Physical performance evaluated with the short physical performance battery | Baseline, 12 weeks | 
| Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV) | 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. | Baseline, 12 weeks | 
| Change in Interleukin-6 (IL-6) concentration | Interleukin-6 concentration in pg/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change | Baseline, 12 weeks | 
| Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) | sTNFR1 concentration in ng/ml will be measured at baseline and be compared to the concentration at 12 weeks to assess any change | Baseline, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frailty, Physical Activity, HIV, Aging, Exercise, mHealth, smartphone, activity tracker, pedometer, text messaging, Short Message Service (SMS)