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The investigators will do an intervention on four groups of previously sedentary post-menopausal women which consists: group 1 - 30 minutes per day of physical protocol; group 2 - 50 minutes per day of physical protocol; group 3 - 70 minutes per day of physical protocol; group 4 - sedentary control women. The protocol consists of three sessions per week of concurrent training (half session with aerobic training and the other part with weight training). Inflammatory and oxidative parameters will be analyzed and the investigators hypothesized that 90 minutes per week of concurrent training (group 1) will reduce the inflammatory parameters and the oxidative stress, and this improvements will be greater so much as the longer the sessions (a dose-response effect). The physical activity practiced out of the intervention will be controlled by a questionnaire (the commuting and leisure sections of the International Physical Activity Questionnaire) and the food intake by a 24-hour food recall.
The protocol will consist of an intervention based on concurrent training, for previously sedentary post-menopausal women divided on four groups: 1) control group; 2) 90 minutes of physical training per week; 3) 150 minutes of training per week; 4) 210 minutes of training per week.
The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.
The aerobic exercise will be performed on cycle-ergometers and the subjects will exercise between the levels 14 and 15 of Borg's scale of perceived exertion. The strength training will be performed on weight machines by a linear periodization, which will consist on a week of adaptation (series of 10 to 12 submaximal repetitions), next three weeks with series of 12 to 14 maximal repetitions, weeks five to eight with series of 10 to 12 maximal repetitions, weeks nine to twelve with series of eight to 10 maximal repetitions. Al participants will do the maximum number of series of strength training that the time permits.
The blood samples will be collected at the beginning of the study (week zero), at the middle (week six) and at the end (week 12). The subjects will fill a 24-hour food recall (to control the food intake) and the commuting and leisure sections of the International Physical Activity Questionnaire (to control the physical activity practiced out of the intervention).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. | |
| 90 minutes per week | Experimental | The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. |
|
| 150 minutes per week | Experimental | The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. |
|
| 210 minutes per week | Experimental | The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise intervention | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Interleukin-6 | Weeks 0, 6 and 12 | |
| Change in Adenosine Deaminase Activity | Weeks 0, 6 and 12 | |
| Change in Butyrylcholinesterase Activity | Weeks 0, 6 and 12 | |
| Change in Thiobarbituric Acid Reactive Substances | Weeks 0, 6 and 12 | |
| Change in Total Thiol Content | Weeks 0, 6 and 12 | |
| Change in Glutathione Peroxidase Activity | Weeks 0, 6 and 12 | |
| Change in Superoxide Dismutase Activity | Weeks 0, 6 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Performance in the Six-minute Walk Test | Weeks 0 and 12 | |
| Change in Handgrip Strength | Measured using a handgrip dynamometer and quantified in kilogram-force | Weeks 0 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index | Weeks 0 and 12 | |
| Change in Minutes Per Week of Physical Activity Out of Intervention | Measured by the commuting and leisure sections of the International Physical Activity Questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matheus P Freitas | Federal University of Pelotas | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. |
| FG001 | 90 Minutes Per Week | The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. Physical exercise intervention |
| FG002 | 150 Minutes Per Week | The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. Physical exercise intervention |
| FG003 | 210 Minutes Per Week | The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. Physical exercise intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. |
| BG001 | 90 Minutes Per Week | The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. Physical exercise intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Interleukin-6 | Posted | Median | Inter-Quartile Range | pg/mL | Weeks 0, 6 and 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. |
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The test performed to estimate the cardiorespiratory fitness was not specific to measure physical activity performed by the women. The test was done walking (six-minute walking test) and the aerobic training was carried out on cycle-ergometers.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Msc. Matheus Pintanel Freitas | Federal Universisty of Pelotas | matheus.pintanel@hotmail.com |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Week 0 and 12 |
| Change in Calories Intake | Measured by a 24-hour food recall and quantified in calories | Weeks 0 and 12 |
| Educational Level | Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Week 0 |
| Household Income | Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Week 0 |
| Age | The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Week 0 |
| Chronic Use of Medication | Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Week 0 |
| Personal Problem |
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| Disease |
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| Physician Decision |
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| Lost before baseline analysis |
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| BG002 | 150 Minutes Per Week | The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. Physical exercise intervention |
| BG003 | 210 Minutes Per Week | The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. Physical exercise intervention |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Household Income | Median | Inter-Quartile Range | US$ |
|
| Resting heart rate | Mean | Standard Deviation | bpm |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Marital status | Number | participants |
|
| Educational level | Number | participants |
|
| Chronic Use of Medication | This variable refers to a chronic use of any medication. | Number | participants |
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| Smoking | Number | participants |
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| Alcohol intake | Number | participants |
|
The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.
Physical exercise intervention
| OG003 | 210 Minutes Per Week | The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. Physical exercise intervention |
|
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| Primary | Change in Adenosine Deaminase Activity | Posted | Mean | Standard Deviation | U/L | Weeks 0, 6 and 12 |
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| Primary | Change in Butyrylcholinesterase Activity | Posted | Mean | Standard Deviation | µmol BuSCh/h/mg of protein | Weeks 0, 6 and 12 |
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| Primary | Change in Thiobarbituric Acid Reactive Substances | Posted | Mean | Standard Deviation | nmol TBARS/mg protein | Weeks 0, 6 and 12 |
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| Primary | Change in Total Thiol Content | Posted | Mean | Standard Deviation | nmol TNB/mg protein | Weeks 0, 6 and 12 |
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| Primary | Change in Glutathione Peroxidase Activity | Posted | Mean | Standard Deviation | U/mg protein | Weeks 0, 6 and 12 |
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| Secondary | Change in Performance in the Six-minute Walk Test | Posted | Mean | Standard Deviation | Meters | Weeks 0 and 12 |
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| Secondary | Change in Handgrip Strength | Measured using a handgrip dynamometer and quantified in kilogram-force | Posted | Mean | Standard Deviation | kgf | Weeks 0 and 12 |
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| Other Pre-specified | Change in Body Mass Index | Posted | Median | Inter-Quartile Range | kg/m² | Weeks 0 and 12 |
|
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| Other Pre-specified | Change in Minutes Per Week of Physical Activity Out of Intervention | Measured by the commuting and leisure sections of the International Physical Activity Questionnaire | Posted | Median | Inter-Quartile Range | minutes per week | Week 0 and 12 |
|
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| Other Pre-specified | Change in Calories Intake | Measured by a 24-hour food recall and quantified in calories | Posted | Mean | Standard Deviation | cal | Weeks 0 and 12 |
|
|
|
| Other Pre-specified | Educational Level | Measured by a questionnaire and quantified categorically in: Incomplete primary school; Primary school; Incomplete high school; High school; Incomplete higher education; Higher education. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Posted | Number | participants | Week 0 |
|
|
|
| Other Pre-specified | Household Income | Measured by a questionnaire and quantified by the income of all persons in the participant's home. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Posted | Median | Inter-Quartile Range | US$ | Week 0 |
|
|
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| Other Pre-specified | Age | The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Posted | Median | Inter-Quartile Range | years | Week 0 |
|
|
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| Other Pre-specified | Chronic Use of Medication | Measured by a questionnaire and quantified categorically in: No; Yes. This variable refers to a chronic use of any medication. The number of baseline participants is not consistent with number provided in the Participant Flow module because two of the beginning participants did not arrived on the first data collection. Due to this, these participants (one of the 90 min/week, and other of the 150 min/week group) were lost to follow-up before the baseline data collection. | Posted | Number | participants | Week 0 |
|
|
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| Primary | Change in Superoxide Dismutase Activity | Posted | Mean | Standard Deviation | U/mg protein | Weeks 0, 6 and 12 |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | 90 Minutes Per Week | The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training. Physical exercise intervention | 0 | 11 | 0 | 11 |
| EG002 | 150 Minutes Per Week | The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training. Physical exercise intervention | 0 | 11 | 0 | 11 |
| EG003 | 210 Minutes Per Week | The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training. Physical exercise intervention | 0 | 11 | 0 | 11 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Week 12 |
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| Primary school |
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| Incomplete high school |
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| High school |
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| Incomplete higher education |
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| Higher education |
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| Yes |
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| Week 6 |
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| Week 12 |
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