A Smartphone Application to Support Physical Activity in HIV Infected People
|ClinicalTrials.gov Identifier: NCT03098095|
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : September 20, 2019
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.
Primary To compare the improvement of physical fitness between the EG and CG groups after 16 weeks of training.
To compare the improvement of the following characteristics between the EG and CG groups after 16 weeks of training:
- Blood lipids,
- Inflammatory markers,
- 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.
The secondary endpoints will be assessed by the 16-week changes in the following measures:
- BMI and %Fat Mass,
- Blood Total-, LDL-, HDL-Cholesterol,
- Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers,
- F12 questionnaire,
- Profile of Mood State questionnaire.
|Condition or disease||Intervention/treatment||Phase|
|Physical Activity HIV Infections||Behavioral: Physical Activity||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open-Label, Randomized, Multicenter, Pilot Study|
|Masking:||None (Open Label)|
|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|
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
- Physical Fitness [ Time Frame: After 16 weeks of training ]Improvement of 15% of maximal oxygen consumption
- Anthropometry [ Time Frame: After 16 weeks of training ]BMI in kg/m^2, weight in kilograms, height in meters
- Anthropometry [ Time Frame: After 16 weeks of training ]Fat Mass in percentage
- Blood Lipids [ Time Frame: After 16 weeks of training ]Total cholesterol mg/dL^1
- Blood Lipids [ Time Frame: After 16 weeks of training ]LDL cholesterol, mg/dL^1
- Blood Lipids [ Time Frame: After 16 weeks of training ]HDL cholesterol mg/dL^1
- Inflammatory Markers [ Time Frame: After 16 weeks of training ]Changes of IL-6, IL-18, hs-CRP, d-Dimer, myostatin, T-cell activation markers
- Mood States [ Time Frame: After 16 weeks of training ]Changes of mood states assessed by Profile of Mood States Questionnairre
- Life quality [ Time Frame: After 16 weeks of training ]Changes of quality of life by F12 questionnaire
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
|Department of Infectious Diseases|
|Milano, Italy, 20127|