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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615001258549
• Date of registration: 17/11/2015
• Prospective Registration: No
• Primary sponsor: San Raffaele Scientific Institute
• 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
• Date of first enrolment: 04/03/2011
• Target sample size: 60
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615001258549.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial;

Countries of recruitment

Italy

Contacts

• Name: Dr Paola Cinque

• Name: Dr Paola Cinque

Key inclusion & exclusion criteria

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
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.

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

HIV infection;Inflammation;Physical inactivity;Metabolic problems;
HIV infection
Inflammation
Physical inactivity
Metabolic problems

Inflammatory and Immune System - Other inflammatory or immune system disorders

Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

Infection - Acquired immune deficiency syndrome (AIDS / HIV)

Intervention(s)

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.

Primary Outcome(s)

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.[Baseline and after 12 weeks of training]

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.[Baseline and after 12 weeks of training]

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

Secondary Outcome(s)

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[After 12 weeks of training]

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.
[After 12 weeks of training]

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.
[After 12 weeks of training ]

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.[After 12 weeks of training]

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). [After 12 weeks of training]

Variation of mental well-being: Medical Outcomes Trust Short-Form 36-item version[After 12 weeks of training]

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 [After 12 weeks of training]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

ANLAIDS onlus

Associazione Solidarieta AIDS (ASA) onlus

Secondary Sponsor(s)

Universita degli Studi di Milano

Ethics review

Status: Approved
Approval date:
Contact:

San Raffaele Scientific Institute