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A Smartphone Application to Support Physical Activity in HIV Infected People

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: NCT03098095
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
University of Milan
Catholic University of the Sacred Heart
IRCCS Lazzaro Spallanzani
University of Roma La Sapienza
Information provided by (Responsible Party):
Paola Cinque, Scientific Institute San Raffaele

Brief Summary:

Physical activity delays all-cause mortality in the general population and reduces the risk of cardiovascular disease (CVD), stroke, type-2 diabetes and some types of cancer (Garber et al., 2011). These diseases are associated with chronic inflammation, which is characterized by activation of inflammatory signalling pathways with abnormal production of cytokines and other mediators (Hotamisligil, 2006). Observational studies of large population cohorts have consistently shown an association between physical inactivity and low-grade systemic inflammation and interventional studies a reduction of inflammatory markers following exercise (Beavers et al., 2010).

Chronic inflammation is also a predominant feature of treated human immunodeficiency virus (HIV) infection (Lederman et al., 2013; Deeks et al., 2013). Compared to age-matched HIV-negative subjects, persons with chronic HIV infection are at higher risk to develop non-acquired immune deficiency syndrome (AIDS) related chronic diseases (Guaraldi et al., 2011), and several studies have shown an association between chronic inflammation and higher cardiovascular risk and overall mortality (Kuller et al., 2008, Duprez et al., 2012).

Recently, the investigators performed a pilot study of moderate physical activity that enrolled sedentary HIV infected subjects treated with combination antiretroviral treatment (cART), consisting of brisk walking, with or without strength exercise. Overall, after 12 weeks of training cholesterol profile and soluble and cell inflammatory markers improved significantly. However, because of the considerable individual variability in exercise responses, a program of physical activity needs be adjusted on an individual basis to be most effective. During recent years, the use of mobile technologies has been implemented for health monitoring interventions, including exercise. We hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness.

The investigators hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness. Therefore, the aim of this project is to improve health and quality of life of patients living with HIV through self-empowerment by use of an innovative mobile application, in order to assist and monitor individualized program of physical activity and diet recommendation.

OBJECTIVES

Primary To compare the improvement of physical fitness between the EG and CG groups after 16 weeks of training.

Secondary

To compare the improvement of the following characteristics between the EG and CG groups after 16 weeks of training:

  1. anthropometry,
  2. Blood lipids,
  3. Inflammatory markers,
  4. Quality of Life,

4. Mood State.

ENDPOINTS Primary The primary objective will be assessed by the proportion of subjects with an improvement from baseline of 15% of maximal oxygen consumption (O2max) through 16 weeks of training.

Secondary

The secondary endpoints will be assessed by the 16-week changes in the following measures:

  1. BMI and %Fat Mass,
  2. Blood Total-, LDL-, HDL-Cholesterol,
  3. Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers,
  4. F12 questionnaire,
  5. Profile of Mood State questionnaire.

Condition or disease Intervention/treatment Phase
Physical Activity HIV Infections Behavioral: Physical Activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-Label, Randomized, Multicenter, Pilot Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of a Mobile Application to Support Physical Activity and Lifestyle Changes in Persons Living With HIV: the SMARTAPP Study.
Actual Study Start Date : April 26, 2017
Actual Primary Completion Date : October 23, 2018
Actual Study Completion Date : October 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Device smartphone. Participants will be trained with a supervised physical activity for 3 days a week for 16 weeks with the use of a smartphone application
Behavioral: Physical Activity
Moderate physical activity

Experimental: Control Group
Participants will train alone with an exercise program for 16 weeks without the use of a smartphone application
Behavioral: Physical Activity
Moderate physical activity




Primary Outcome Measures :
  1. Physical Fitness [ Time Frame: After 16 weeks of training ]
    Improvement of 15% of maximal oxygen consumption


Secondary Outcome Measures :
  1. Anthropometry [ Time Frame: After 16 weeks of training ]
    BMI in kg/m^2, weight in kilograms, height in meters

  2. Anthropometry [ Time Frame: After 16 weeks of training ]
    Fat Mass in percentage

  3. Blood Lipids [ Time Frame: After 16 weeks of training ]
    Total cholesterol mg/dL^1

  4. Blood Lipids [ Time Frame: After 16 weeks of training ]
    LDL cholesterol, mg/dL^1

  5. Blood Lipids [ Time Frame: After 16 weeks of training ]
    HDL cholesterol mg/dL^1

  6. Inflammatory Markers [ Time Frame: After 16 weeks of training ]
    Changes of IL-6, IL-18, hs-CRP, d-Dimer, myostatin, T-cell activation markers

  7. Mood States [ Time Frame: After 16 weeks of training ]
    Changes of mood states assessed by Profile of Mood States Questionnairre


Other Outcome Measures:
  1. Life quality [ Time Frame: After 16 weeks of training ]
    Changes of quality of life by F12 questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age ≥18 years;
  • with or without cART;
  • either sedentary or already practicing mild/moderate physical activity;

Exclusion Criteria:

  • any disease requiring hospitalization in the 6 weeks before enrolment;
  • medical conditions contraindicating exercise as established by a sport medicine specialist;
  • current substance or alcohol abuse.

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): NCT03098095


Locations
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Italy
Department of Infectious Diseases
Milano, Italy, 20127
Sponsors and Collaborators
Scientific Institute San Raffaele
University of Milan
Catholic University of the Sacred Heart
IRCCS Lazzaro Spallanzani
University of Roma La Sapienza
Publications of Results:
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Responsible Party: Paola Cinque, Medical Doctor, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT03098095    
Other Study ID Numbers: OSR - Prot. SMARTAPP
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases