Trial Outcomes & Findings for Exercise, Oxidative Stress and HIV (NCT NCT00950937)
NCT ID: NCT00950937
Last Updated: 2009-08-11
Results Overview
The total glutathione content in erythrocyte concentrate at three moments: baseline, aerobic and resistance exercise.
Recruitment status
COMPLETED
Target enrollment
28 participants
Primary outcome timeframe
3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).
Results posted on
2009-08-11
Participant Flow
Participant milestones
| Measure |
HIV Group
HIV infected persons
|
Control Group
Non HIV-infected persons
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise, Oxidative Stress and HIV
Baseline characteristics by cohort
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age Continuous
|
39.2 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
36 years
STANDARD_DEVIATION 10.6 • n=7 Participants
|
37.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14.0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14.0 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28.0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
Total Glutathione
Baseline
|
1,964 nmoles glutathione/ ml of sample
Interval 319.0 to
|
3,490 nmoles glutathione/ ml of sample
Interval 597.0 to
|
|
Total Glutathione
Aerobic
|
1,865 nmoles glutathione/ ml of sample
Interval 780.0 to
|
3,995 nmoles glutathione/ ml of sample
|
|
Total Glutathione
Resistance
|
1,767 nmoles glutathione/ ml of sample
Interval 516.0 to
|
3,206 nmoles glutathione/ ml of sample
|
SECONDARY outcome
Timeframe: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).Antioxidant activity of the catalase enzyme at three moments: baseline, aerobic and exercise.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
Catalase Activity
Baseline
|
0.578 units of catalase /mg protein
Interval 0.049 to 1.338
|
0.967 units of catalase /mg protein
Interval 0.312 to 2.322
|
|
Catalase Activity
Aerobic
|
1.03 units of catalase /mg protein
Interval 0.316 to 2.598
|
0.855 units of catalase /mg protein
Interval 0.087 to 1.688
|
|
Catalase Activity
Resistance
|
0.566 units of catalase /mg protein
Interval 0.317 to 3.51
|
1.009 units of catalase /mg protein
Interval 0.333 to 2.096
|
SECONDARY outcome
Timeframe: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).Antioxidant activity of the Glutathione S-transferase enzyme at three moments: baseline, aerobic and resistance exercise.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
Glutathione S-transferase (GST)
Baseline
|
0.34 micromol of GST/min/mg of protein
Interval 0.18 to 0.58
|
0.5 micromol of GST/min/mg of protein
Interval 0.42 to 0.56
|
|
Glutathione S-transferase (GST)
Aerobic
|
0.34 micromol of GST/min/mg of protein
Interval 0.09 to 0.42
|
0.36 micromol of GST/min/mg of protein
Interval 0.34 to 0.51
|
|
Glutathione S-transferase (GST)
Resistance
|
0.45 micromol of GST/min/mg of protein
Interval 0.31 to 0.63
|
0.46 micromol of GST/min/mg of protein
Interval 0.43 to 0.65
|
SECONDARY outcome
Timeframe: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).Thiobarbituric acid-reactive substances (TBARS) assay was used as an index of lipid peroxidation in erythrocytes, at three moments: baseline, aerobic and resistance exercise.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
Lipid Peroxidation
Baseline
|
2.356 picomol of TBARS/mg protein
Interval 1.27 to 3.12
|
2.888 picomol of TBARS/mg protein
Interval 1.118 to 5.002
|
|
Lipid Peroxidation
Aerobic
|
2.328 picomol of TBARS/mg protein
Interval 0.909 to 2.922
|
4.164 picomol of TBARS/mg protein
Interval 2.763 to 6.79
|
|
Lipid Peroxidation
Resistance
|
2.348 picomol of TBARS/mg protein
Interval 0.917 to 3.794
|
3.205 picomol of TBARS/mg protein
Interval 1.753 to 6.84
|
SECONDARY outcome
Timeframe: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).T CD4 lymphocytes counts at three moments: baseline, aerobic and resistance exercise.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
T CD4
Aerobic
|
428 Cell/ul of blood
Interval 70.0 to 811.0
|
968 Cell/ul of blood
Interval 553.0 to 1387.0
|
|
T CD4
Baseline
|
417 Cell/ul of blood
Interval 116.0 to 1132.0
|
984 Cell/ul of blood
Interval 594.0 to 2145.0
|
|
T CD4
Resistance
|
378 Cell/ul of blood
Interval 70.0 to 981.0
|
974 Cell/ul of blood
Interval 643.0 to 1411.0
|
SECONDARY outcome
Timeframe: 3 times - baseline (before the peak oxygen uptake test), aerobic (immediately after aerobic exercise) and resistance (immediately after resistance exercise).Neutrophil count at three moments: baseline, aerobic and resistance exercise.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
Neutrophil Count
Baseline
|
3,237 Cell/ul of blood
|
3,212 Cell/ul of blood
|
|
Neutrophil Count
Aerobic
|
3,285 Cell/ul of blood
|
3,476 Cell/ul of blood
|
|
Neutrophil Count
Resistance
|
3,511 Cell/ul of blood
|
3,563 Cell/ul of blood
|
SECONDARY outcome
Timeframe: 1 time, before the exercise protocolIs the maximum capacity of an individual's body to transport and utilize oxygen during incremental exercise.
Outcome measures
| Measure |
HIV Group
n=14 Participants
HIV infected persons
|
Control Group
n=14 Participants
Non HIV-infected persons
|
|---|---|---|
|
Peak Oxygen Uptake
|
1,673 ml/min
Standard Deviation 349
|
2,167 ml/min
Standard Deviation 597
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place