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Trial registered on ANZCTR

Registration number

ACTRN12615001258549

Ethics application status

Approved

Date submitted

14/10/2015

Date registered

17/11/2015

Date last updated

17/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of moderate physical activity (briskwalking) on metabolic and inflammatory markers in people living with HIV

Scientific title

Effects of moderate physical activity on metabolic and inflammatory markers in HIV infected patients treated with combination antiretroviral therapy

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

HIV infection

Inflammation

Physical inactivity

Metabolic problems

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Moderate physical activity: groups of 10-15 subjects trained three times a week for 12 weeks in the periods March-July, 2011 and 2012.

1) Training group 1: 60 minutes of brisk walking at an intensity of 65-75% of maximal heart rate.

2) Training group 2: 30 minutes of circuit training: crunch, lat machine, chest press, leg press, leg extension, sitting calf. Each exercise was repeated 12 times for three sets at 65% of 1-Repetition Maximum Test After that 60 minutes of brisk walking at an intensity of 65-75% of maximal heart rate was performed (Total training time 90 minutes).

Professional coaches followed all the training sessions providing technical instruction, supervision and encouragement. Participants received generic dietary advice. Adherence was measured by frequency of attended training sessions.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

Training group 1: comparator

Training group 2: intervention group

Control group

Active

Outcomes

Primary outcome [1]

Composite primary outcome: variation of metabolic markers including those defining the metabolic syndrome.

Triglycerides, HDL cholesterol and fasting glucose were collected at baseline and after 12 weeks of training; fasting blood samples were collected and processed locally according to standardized protocols.

Timepoint [1]

Baseline and after 12 weeks of training

Primary outcome [2]

Waist Circumference was measured at baseline and after 12 weeks of training with a tape at the mid-point between the last costal arch and the iliac crest.

Timepoint [2]

Baseline and after 12 weeks of training

Primary outcome [3]

Blood pressure was measured at baseline and after 12 weeks of training with a sphygmomanometer.

Timepoint [3]

Baseline and after 12 weeks of training

Secondary outcome [1]

Variation of mental well-being: Medical Outcomes Trust Short-Form 36-item version

Timepoint [1]

After 12 weeks of training

Secondary outcome [2]

Variation of autonomic control

After an initial period of resting of 20 min in supine position, beat-by-beat series of R-R intervals were measured in supine position for 10 min and then in orthostatic position for other 10 min, by a HR monitor (S810, Polar Electro Oy, Finland), validated for HRV analysis

Timepoint [2]

After 12 weeks of training

Secondary outcome [3]

Variation of bone metabolism

Bone mineral density, t-score and z-score in spine and femoral, trochanter and ward iwas measured by dual-energy X-ray absorptiometry (DEXA) (Lunar Prodigy, version 8.8, GE Medical Systems, Madison, WI).

Timepoint [3]

After 12 weeks of training

Secondary outcome [4]

Variation of body composition

Anthropometric variables included weight, body mass index (BMI), waist, hip, and thigh circumference on dominant side.

Total and % fat mass, lean mass and body mineral content (BMC) at arms, limbs, trunk and as total body was measured by dual-energy X-ray absorptiometry (DEXA) (Lunar Prodigy, version 8.8, GE Medical Systems, Madison, WI).

Superficial and visceral fat was measured by ultrasonography at the periumbilical skin-point.

Timepoint [4]

After 12 weeks of training

Secondary outcome [5]

Variation of inflammatory markers

Soluble markers. Soluble biomarkers were measured in cryopreserved plasma samples, drawn at baseline and after 12 weeks of training, by commercially available enzyme-linked immunosorbent assays according to manufacturers’ recommendation. These included high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6) and soluble CD14 (sCD14)(R&D Systems, Minneapolis, MN), D-dimer (Asserachrom, Diagnostica Stago, Asnieres-Sur-Seine, France), interleukin-18 (IL-18)(Medical and Biological Laboratories, Nagoya, Japan) and myostatin (Cusabio Biotech, Wuhan, China).

Flow cytometry for cell-activation markers. T-cell activation was measured on cryopreserved peripheral blood mononuclear cells isolated by Ficoll-Paque gradient from EDTA-anticoagulated whole blood. After thawing and PBS-washing, 3 x 105 cells were stained using phycoerythrin (PE)-conjugated anti-HLA-DR, PE-cyanin red 5.1-conjugated anti-CD38, Alexa Fluor 647-conjugated anti-CD3, fluorescein isothiocyanate-conjugated anti-CD4 or anti-CD8 (BD-Biosciences, San Diego, CA). CD38+ and HLA-DR+ cells were gated from the CD3+/CD4+ or CD3+/CD8+ cells on a 2-dimensional dot plot. Analyses were performed by FACSCalibur with CellQuest software (BD-Biosciences) and results reported as percentages of CD3+/CD4+ and CD3+/CD8+ T-cells expressing both HLA-DR and CD38.

Timepoint [5]

After 12 weeks of training

Secondary outcome [6]

Variation of physical fitness

6 Minutes Walking Test (6MWT). Participants were instructed to walk as fast as possible for six minutes on a 400 m outdoor athletic track. HRmean was recorded during the test, blood lactate concentration was assessed before and 3 minutes after 6MWT (Lactate ProTM, Arkray KdK, Japan), and the Rating of Perceived Exertion (RPE) before and at the end of 6MWT.

Strength measurements. 1-RM test assessed the maximal load lifted in one repetition, and the 30-seconds crunch test the number of crunches performed in 30 seconds.

Timepoint [6]

After 12 weeks of training

Secondary outcome [7]

Variation of additional metabolic markers

Blood examination included complete blood count; standard biochemical exams with fasting total, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) cholesterol, triglycerides, glucose, insulin, HbA1c; CD4+ and CD8+ T-cell counts, HIV-1-RNA plasma level (Abbott RealTime HIV-1 assay). The Homeostatic Model Assessment (HOMA)-I and the Veterans Aging Cohort Study Risk (VACS) indexes were calculated

Timepoint [7]

After 12 weeks of training

Eligibility

Key inclusion criteria

Age: between 18 and 75 years of age;
HIV infection
cART: greater than 6 months;
Sedentary lifestyle: defined as physical activity for <2 days per week for <20 minutes per session;
Either evidence of lipodystrophy or of at least one of the Adult Treatment Panel III definition criteria of the metabolic syndrome

Minimum age

18 Years

Maximum age

75 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Any disease requiring hospitalization in the 6 weeks before enrolment; medical conditions contraindicating exercise as established by a sport medicine specialist; inability to walk at brisk pace; current substance or alcohol abuse.

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

4/03/2011

Date of last participant enrolment

Anticipated

Actual

20/02/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Milano

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Associazione Solidarieta AIDS (ASA) onlus

Address [1]

Via Arena, 25, 20142 Milano

Country [1]

Italy

Funding source category [2]

Charities/Societies/Foundations

Name [2]

ANLAIDS onlus

Address [2]

via Giovanni Giolitti, 42 00185 Roma

Country [2]

Italy

Primary sponsor type

Hospital

Name

San Raffaele Scientific Institute

Address

Via Olgettina, 60
20132 Milano

Country

Italy

Secondary sponsor category [1]

University

Name [1]

Universita degli Studi di Milano

Address [1]

Via Festa del Perdono, 7
20122 Milano

Country [1]

Italy

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

San Raffaele Scientific Institute

Ethics committee address [1]

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

Approval date [1]

03/03/2011

Ethics approval number [1]

Summary

Brief summary

The use of antiretroviral drugs has dramatically reduced the progression and mortality of HIV infection, which has now become a chronic condition. However, this treatment involves taking several medications, which must be used in combination for the entire life. Side effects are frequent and occur with alterations of cardiovascular system, renal system, bone mineralisation. In addition, chronic HIV infection is per se associated with increased systemic immune activation. As a result there is an increased risk in HIV-infected patients to develop cardiovascular and cerebrovascular diseases, diabetes, renal failure, osteoporosis and other problems resulting from metabolic disorders.

There are several measures that can be implemented to reduce the risk of developing these conditions, which include both interventions of lifestyle, such as diet and exercise, and different pharmacological approaches. Among these interventions, there are several evidences that physical activity is helpful in reducing the risk of cardiovascular diseases in the general population, changing the risk factors for these diseases. There are preliminary evidences that physical exercise is also effective in HIV-positive people with impaired metabolism in modifying several risk factors for developing cardiovascular disease.

The effects of physical activity are different depending on the type and intensity of physical activity. Generally, aerobic exercise improves cardiovascular parameters, while resistance training counteracts the reduction of muscle mass. In people while type 2 diabetes, the combination of the two types of activity improves cardiovascular and metabolic parameters. Aerobic exercise seems effective in reducing body fat in HIV-infected people with increased storage of fat in the abdomen, while the combination of aerobic and resistance training seems to be effective in reducing abdominal fat, total fat, total cholesterol, LDL-cholesterol and triglycerides.

The study aims to evaluate the benefits of moderate physical activity for people living with HIV infection treated with antiretroviral drugs, including aerobic physical activity or the combination of aerobic and resistance training. Benefits will be measured by an improvement of the state of health, physical fitness, and metabolic and inflammatory markers, and it also intends to assess whether the combination of aerobic and resistance training is superior to aerobic activity only. The innovative aspect of this program in the inclusion, as aerobic activity, of brisk walking, that is a technique for walking a high speed engaging significantly the muscular and cardiovascular system.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Paola Cinque

Address

Department of Infectious Diseases
San Raffaele Hospital
Va Stamira d'Ancona
20127 Milano

Country

Italy

Phone

+39 0226433160

Fax

cinque.paola@hsr.it

Contact person for public queries

Name

Paola Cinque

Address

Department of Infectious Diseases
San Raffaele Hospital
Va Stamira d'Ancona
20127 Milano

Country

Italy

Phone

+39 0226433160

Fax

cinque.paola@hsr.it

Contact person for scientific queries

Name

Paola Cinque

Address

Department of Infectious Diseases
San Raffaele Hospital
Va Stamira d'Ancona
20127 Milano

Country

Italy

Phone

+39 0226433160

Fax

cinque.paola@hsr.it

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A pilot study of brisk walking in sedentary combination antiretroviral treatement (cART)- treated patients: Benefit on soluble and cell inflammatory markers.	2017	https://dx.doi.org/10.1186/s12879-016-2095-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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