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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708640
• Other study ID #: IRB00169068
• Secondary ID: K23AI108357
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: June 2022
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Digital Activity Tracker
Group wears physical activity tracker and receives physical activity feedback information informed by the tracker
• Smart Text Messaging
Group receives personalized, health coaching via "smart" text messages
• Physical Activity Counseling
Group receives baseline counseling on physical activity

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean daily step count	Mean daily step count will be assessed using a digital physical activity tracker	Baseline, 12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Percent change in fat mass	Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan	Baseline, 12 weeks
Secondary	Percent change in lean mass	Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan	Baseline, 12 weeks
Secondary	Change in Physical performance as assessed by the physical performance battery	Physical performance evaluated with the short physical performance battery	Baseline, 12 weeks
Secondary	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
Secondary	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
Secondary	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