HIV InfectionsNCT00950937
Exercise, Oxidative Stress and HIV
An observational study of HIV Infections, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to compare oxidative stress markers and the immunologic characteristics of HIV-infected and non-HIV subjects during a bout of moderate aerobic exercise followed by resistance exercises Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2006to Jul 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The participants of the HIV group were recruited at the outpatient HIV/AIDS care unit of the Hospital de Clínicas de Porto Alegre (HCPA), whereas the control group (non-HIV) was formed by volunteers of the city of Porto Alegre, Rio Grande do Sul, Brazil
Who may be able to join
- HIV Group:without contraindications for exercise training; to highly active antiretroviral therapy (HAART) for at least 6 months before enrollment; be classified as low level of physical activity by international physical activity questionnaire (IPAQ) and did not use antioxidant supplements.
- Control Group:negative result for HIV-1 test and the other criteria described above
Who cannot join
- Subjects with previous history of cardiovascular and neurological disease, diabetes, dyslipidemia, tobacco using, physical disability and pregnant women were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Outpatient HIV/AIDS care unit of the Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: A Case-control Study to Test the Effects of a Bout of Aerobic Exercise Followed by Resistance Training on Antioxidant System in Human Immunodeficiency Virus (HIV)-Infected and Non-HIV Subjects
The purpose of this study is to compare oxidative stress markers and the immunologic characteristics of HIV-infected and non-HIV subjects during a bout of moderate aerobic exercise followed by resistance exercises
- Conditions
- HIV Infections
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV Group | HIV infected persons | |
| Control Group | Non HIV-infected persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Glutathione
The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.
Measured: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Secondary outcomes (6)
Catalase Activity
Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.
Measured: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Glutathione S-transferase (GST)
Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.
Measured: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Lipid Peroxidation
Thiobarbituric acid-reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.
Measured: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
T CD4
T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.
Measured: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Neutrophil Count
Neutrophil count at three moments: baseline, aerobic and resistance exercise.
Measured: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Peak Oxygen Uptake
Is the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.
Measured: 1 time, before the exercise protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startJun 2006
- Primary completionJan 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Pedro Dall'Ago, Professor, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950937
- Sponsor's protocol ID
- 06067
- Status last verified
- Aug 2009
- First submitted
- 16 Feb 2009
- Last updated
- 11 Aug 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-control Study to Test the Effects of a Bout of Aerobic Exercise Followed by Resistance Training on Antioxidant System in Human Immunodeficiency Virus (HIV)-Infected and Non-HIV Subjects
- ClinicalTrials.gov ID
- NCT00950937
- Acronym / sponsor ID
- 06067
- Conditions
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Posted 3 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare oxidative stress markers and the immunologic characteristics of HIV-infected and non-HIV subjects during a bout of moderate aerobic exercise followed by resistance exercises
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV Group | – | –HIV infected persons |
| Control Group | – | –Non HIV-infected persons |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants of the HIV group were recruited at the outpatient HIV/AIDS care unit of the Hospital de Clínicas de Porto Alegre (HCPA), whereas the control group (non-HIV) was formed by volunteers of the city of Porto Alegre, Rio Grande do Sul, Brazil
Key inclusion criteria (2 listed)
- HIV Group:without contraindications for exercise training; to highly active antiretroviral therapy (HAART) for at least 6 months before enrollment; be classified as low level of physical activity by international physical activity questionnaire (IPAQ) and did not use antioxidant supplements.
- Control Group:negative result for HIV-1 test and the other criteria described above
Key exclusion criteria (1 listed)
- Subjects with previous history of cardiovascular and neurological disease, diabetes, dyslipidemia, tobacco using, physical disability and pregnant women were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Glutathione
Time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.
6 secondary outcomes
Catalase Activity
Time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Glutathione S-transferase (GST)
Time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Lipid Peroxidation
Time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
T CD4
Time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Neutrophil Count
Time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Peak Oxygen Uptake
Time frame: 1 time, before the exercise protocol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Dall'Ago, Professor principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Glutathione (time frame: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009; AzTrials last refreshed its copy on 28 Oct 2026.