A Smartphone Application to Support Physical Activity in HIV Infected People

NCT03098095 | Completed DMC

• 1 other identifier: OSR - Prot. SMARTAPP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Physical Activity; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Physical Fitness

  Improvement of 15% of maximal oxygen consumption

  After 16 weeks of training

Secondary Outcomes (7)

• Anthropometry

  After 16 weeks of training

• Anthropometry

  After 16 weeks of training

• Blood Lipids

  After 16 weeks of training

• Blood Lipids

  After 16 weeks of training

• Blood Lipids

  After 16 weeks of training

Other Outcomes (1)

• Life quality

  After 16 weeks of training

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control Group

EXPERIMENTAL

Participants will train alone with an exercise program for 16 weeks without the use of a smartphone application

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

Moderate physical activity

Control Group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scientific Institute San Raffaele: lead
• University of Milan: collaborator
• Catholic University of the Sacred Heart: collaborator
• IRCCS Lazzaro Spallanzani: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (1)

Department of Infectious Diseases

Milan, 20127, Italy

Location

Related Publications (1)

• Bonato M, Galli L, Passeri L, Longo V, Pavei G, Bossolasco S, Bertocchi C, Cernuschi M, Balconi G, Merati G, Lazzarin A, La Torre A, Cinque P. A pilot study of brisk walking in sedentary combination antiretroviral treatement (cART)- treated patients: benefit on soluble and cell inflammatory markers. BMC Infect Dis. 2017 Jan 11;17(1):61. doi: 10.1186/s12879-016-2095-9.

  PMID: 28077069 RESULT

MeSH Terms

Conditions

Motor Activity; HIV Infections

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Open-Label, Randomized, Multicenter, Pilot Study

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 31, 2017
• Study Start: April 26, 2017
• Primary Completion: October 23, 2018
• Study Completion: October 23, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)