NCT03098095

A Smartphone Application to Support Physical Activity in HIV Infected People

Completed NA Last updated 20 September 2019

What this trial tests

NA trial testing Physical Activity in Physical Activity in 38 participants. Completed in 23 October 2018.

Timeline

26 April 2017

Primary endpoint
23 October 2018

23 October 2018

Quick facts

Lead sponsor	Scientific Institute San Raffaele
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	26 April 2017
Primary completion	23 October 2018
Estimated completion	23 October 2018
Sites	1 location across Italy

Drugs / interventions tested

• Physical Activity

Conditions studied

• Physical Activity — all drugs for Physical Activity →
• HIV Infections — all drugs for HIV Infections →

Sponsor

Scientific Institute San Raffaele

Who can join

18 and older, any sex, with Physical Activity or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.