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Exercise, Oxidative Stress and HIV

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ClinicalTrials.gov Identifier: NCT00950937
Recruitment Status : Completed
First Posted : August 3, 2009
Results First Posted : August 3, 2009
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition HIV Infections
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description HIV infected persons Non HIV-infected persons
Period Title: Overall Study
Started 14 14
Completed 14 14
Not Completed 0 0
Arm/Group Title HIV Group Control Group Total
Hide Arm/Group Description HIV infected persons Non HIV-infected persons Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
14
 100.0%
14
 100.0%
28.0
>=65 years
0
   0.0%
0
   0.0%
0.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
39.2  (8.7) 36  (10.6) 37.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
7
  50.0%
14.0
Male
7
  50.0%
7
  50.0%
14.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Total Glutathione
Hide Description The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.
Time Frame 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: nmoles glutathione/ ml of sample
Baseline
1,964
(319 to 2,577)
3,490
(597 to 7,596)
Aerobic
1,865
(780 to 5,006)
3,995
(2,308 to 6,068)
Resistance
1,767
(516 to 2,420)
3,206
(2,456 to 7,202)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
2.Secondary Outcome
Title Catalase Activity
Hide Description Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.
Time Frame 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: units of catalase /mg protein
Baseline
0.578
(0.049 to 1.338)
0.967
(0.312 to 2.322)
Aerobic
1.03
(0.316 to 2.598)
0.855
(0.087 to 1.688)
Resistance
0.566
(0.317 to 3.510)
1.009
(0.333 to 2.096)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
3.Secondary Outcome
Title Glutathione S-transferase (GST)
Hide Description Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.
Time Frame 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: micromol of GST/min/mg of protein
Baseline
0.34
(0.18 to 0.58)
0.5
(0.42 to 0.56)
Aerobic
0.34
(0.09 to 0.42)
0.36
(0.34 to 0.51)
Resistance
0.45
(0.31 to 0.63)
0.46
(0.43 to 0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
4.Secondary Outcome
Title Lipid Peroxidation
Hide Description Thiobarbituric acid–reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.
Time Frame 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: picomol of TBARS/mg protein
Baseline
2.356
(1.27 to 3.12)
2.888
(1.118 to 5.002)
Aerobic
2.328
(0.909 to 2.922)
4.164
(2.763 to 6.790)
Resistance
2.348
(0.917 to 3.794)
3.205
(1.753 to 6.840)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
5.Secondary Outcome
Title T CD4
Hide Description T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.
Time Frame 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: Cell/ul of blood
Baseline
417
(116 to 1132)
984
(594 to 2145)
Aerobic
428
(70 to 811)
968
(553 to 1387)
Resistance
378
(70 to 981)
974
(643 to 1411)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
6.Secondary Outcome
Title Neutrophil Count
Hide Description Neutrophil count at three moments: baseline, aerobic and resistance exercise.
Time Frame 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Inter-Quartile Range)
Unit of Measure: Cell/ul of blood
Baseline
3,237
(1,901 to 4,207)
3,212
(2,328 to 4,174)
Aerobic
3,285
(1,610 to 5,476)
3,476
(2,184 to 9,236)
Resistance
3,511
(1,531 to 5,977)
3,563
(2,422 to 9,214)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon test was utilized to compare the three moments: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection HIV Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Friedman Test
Comments Friedman to compare: baseline vs. aerobic, baseline vs. resistance and aerobic vs. resistance. Wilcoxon was applied to locate the differences
7.Secondary Outcome
Title Peak Oxygen Uptake
Hide Description Is the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.
Time Frame 1 time, before the exercise protocol
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HIV Group Control Group
Hide Arm/Group Description:
HIV infected persons
Non HIV-infected persons
Overall Number of Participants Analyzed 14 14
Median (Standard Deviation)
Unit of Measure: ml/min
1,673  (349) 2,167  (597)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection HIV Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments Paired t-test was utilized to compare the two groups (HIV group and Control group)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Pedro Dall'Ago
Organization: Hospital de Clínicas de Porto Alegre
Phone: 555133038751
Responsible Party: Pedro Dall'Ago, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00950937     History of Changes
Other Study ID Numbers: 06067
First Submitted: February 16, 2009
First Posted: August 3, 2009
Results First Submitted: February 16, 2009
Results First Posted: August 3, 2009
Last Update Posted: August 11, 2009