Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03708640
Recruitment Status : Enrolling by invitation
First Posted : October 17, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Other: Digital Activity Tracker Other: Smart Text Messaging Other: Physical Activity Counseling Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Pilot Study to Evaluate the Effect of a Mobile Health Physical Activity Intervention for HIV-associated Frailty
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Physical Activity Counseling

Group receives baseline physical activity counseling.

Group does not receive personalized, health coaching via "smart" text messages.

Other: Physical Activity Counseling
Group receives baseline counseling on physical activity

Experimental: Digital Activity Tracker/Smart Text Messaging

Group receives baseline physical activity counseling.

Group receives personalized, health coaching via "smart" text messages informed by digital activity tracker.

Other: Digital Activity Tracker
Group wears physical activity tracker and receives physical activity feedback information informed by the tracker

Other: Smart Text Messaging
Group receives personalized, health coaching via "smart" text messages

Other: Physical Activity Counseling
Group receives baseline counseling on physical activity




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Frailty as assessed by the Fried-based physical frailty phenotype [ Time Frame: 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)

  2. Change in Physical Fitness as assessed by 12 minute walk [ Time Frame: Baseline, 12 weeks ]
    Physical fitness of participants will be assessed by the ability to do a 12 minute walk

  3. Change in Muscle strength as assessed by isokinetic resistance [ Time Frame: Baseline, 12 weeks ]
    Muscle strength evaluated using isokinetic resistance testing on a Biodex system measuring peak torque expressed as foot pounds (lbs)

  4. Percent change in fat mass [ Time Frame: Baseline, 12 weeks ]
    Fat mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan

  5. Percent change in lean mass [ Time Frame: Baseline, 12 weeks ]
    Lean mass will be measured using the dual-energy x-ray absorptiometry (DXA) scan

  6. Change in Physical performance as assessed by the physical performance battery [ Time Frame: Baseline, 12 weeks ]
    Physical performance evaluated with the short physical performance battery

  7. Change in Quality of Life as assessed by the Medical Outcomes Study HIV Health Survey (MOS-HIV) [ Time Frame: 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.

  8. Change in Interleukin-6 (IL-6) concentration [ Time Frame: 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

  9. Change in soluble Tumor Necrosis Factor Receptor 1 (sTNFR1) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708640


Locations
Layout table for location information
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Layout table for investigator information
Principal Investigator: Damani Piggott, MD, PhD Johns Hopkins University

Publications:
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03708640     History of Changes
Other Study ID Numbers: IRB00169068
K23AI108357 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:
Frailty
Physical Activity
HIV
Aging
Exercise
mHealth
smartphone
activity tracker
pedometer
text messaging
Short Message Service (SMS)