Immune System Diseases, Oxidative Stress
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BEHAVIORALPhysical exercise intervention
Sponsors
Federal University of Pelotas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women have to be in the postmenopausal period, without physical disorders.
Exclusion criteria
* Women who answer positively to, at least, one of the issues of the PAR-Q instrument; * Women with diabetes and/or cancer history; * Women who underwent oophorectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Adenosine Deaminase Activity | Weeks 0, 6 and 12 |
| Change in Interleukin-6 | Weeks 0, 6 and 12 |
| Change in Superoxide Dismutase Activity | Weeks 0, 6 and 12 |
| Change in Glutathione Peroxidase Activity | Weeks 0, 6 and 12 |
| Change in Total Thiol Content | Weeks 0, 6 and 12 |
| Change in Thiobarbituric Acid Reactive Substances | Weeks 0, 6 and 12 |
| Change in Butyrylcholinesterase Activity | Weeks 0, 6 and 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Performance in the Six-minute Walk Test | Weeks 0 and 12 | — |
| Change in Handgrip Strength | Weeks 0 and 12 | Measured using a handgrip dynamometer and quantified in kilogram-force |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chronic Use of Medication | Week 0 | 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. |
| Age | Week 0 | 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. |
| Household Income | Week 0 | 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. |
| Educational Level | Week 0 | 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. |
| Change in Calories Intake | Weeks 0 and 12 | Measured by a 24-hour food recall and quantified in calories |
| Change in Minutes Per Week of Physical Activity Out of Intervention | Week 0 and 12 | Measured by the commuting and leisure sections of the International Physical Activity Questionnaire |
| Change in Body Mass Index | Weeks 0 and 12 | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. | 9 |
| 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 | 10 |
| 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 | 10 |
| 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 | 11 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Disease | 0 | 2 | 2 | 1 |
| Overall Study | Lost before baseline analysis | 0 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 1 |
| Overall Study | Personal Problem | 2 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | 210 Minutes Per Week | Control | 150 Minutes Per Week | Total | 90 Minutes Per Week |
|---|---|---|---|---|---|
| Age, Continuous | 63 years | 70 years | 61.5 years | 63 years | 62 years |
| Alcohol intake Daily (one dose) | 0 participants | 0 participants | 1 participants | 1 participants | 0 participants |
| Alcohol intake No | 6 participants | 4 participants | 2 participants | 18 participants | 6 participants |
| Alcohol intake Sporadically | 5 participants | 5 participants | 7 participants | 21 participants | 4 participants |
| Chronic Use of Medication No | 1 participants | 0 participants | 1 participants | 3 participants | 1 participants |
| Chronic Use of Medication Yes | 10 participants | 9 participants | 9 participants | 37 participants | 9 participants |
| Diastolic blood pressure | 78.7 mmHg STANDARD_DEVIATION 7.1 | 74.4 mmHg STANDARD_DEVIATION 8.8 | 76.0 mmHg STANDARD_DEVIATION 7 | 76.4 mmHg STANDARD_DEVIATION 10.6 | 75.2 mmHg STANDARD_DEVIATION 17.2 |
| Educational level Higher education | 1 participants | 1 participants | 0 participants | 3 participants | 1 participants |
| Educational level High school | 2 participants | 3 participants | 4 participants | 10 participants | 1 participants |
| Educational level Incomplete higher education | 2 participants | 0 participants | 0 participants | 2 participants | 0 participants |
| Educational level Incomplete high school | 0 participants | 1 participants | 2 participants | 4 participants | 1 participants |
| Educational level Incomplete primary school | 4 participants | 1 participants | 3 participants | 12 participants | 4 participants |
| Educational level Primary school | 2 participants | 3 participants | 1 participants | 9 participants | 3 participants |
| Household Income | 423 US$ | 846 US$ | 867 US$ | 612 US$ | 538 US$ |
| Marital status Married | 1 participants | 4 participants | 7 participants | 16 participants | 4 participants |
| Marital status Others | 10 participants | 5 participants | 3 participants | 24 participants | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 2 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 8 Participants | 31 Participants | 8 Participants |
| Region of Enrollment Brazil | 11 participants | 9 participants | 10 participants | 40 participants | 10 participants |
| Resting heart rate | 68.1 bpm STANDARD_DEVIATION 12.1 | 65.8 bpm STANDARD_DEVIATION 7.9 | 64.5 bpm STANDARD_DEVIATION 9.2 | 65.5 bpm STANDARD_DEVIATION 10.6 | 64.7 bpm STANDARD_DEVIATION 13.1 |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 10 Participants | 40 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Smoking No | 10 participants | 8 participants | 9 participants | 35 participants | 8 participants |
| Smoking Yes | 1 participants | 1 participants | 1 participants | 5 participants | 2 participants |
| Systolic blood pressure | 121.0 mmHg STANDARD_DEVIATION 14.2 | 119.8 mmHg STANDARD_DEVIATION 6.7 | 121.2 mmHg STANDARD_DEVIATION 12.4 | 120.8 mmHg STANDARD_DEVIATION 14.3 | 118.2 mmHg STANDARD_DEVIATION 20.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Change in Adenosine Deaminase Activity
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Adenosine Deaminase Activity | Week 12 | 43.11 U/L | Standard Deviation 20.21 |
| Control | Change in Adenosine Deaminase Activity | Baseline | 31.12 U/L | Standard Deviation 5.96 |
| Control | Change in Adenosine Deaminase Activity | Week 6 | 42.11 U/L | Standard Deviation 10.74 |
| 90 Minutes Per Week | Change in Adenosine Deaminase Activity | Week 6 | 42.54 U/L | Standard Deviation 10.07 |
| 90 Minutes Per Week | Change in Adenosine Deaminase Activity | Baseline | 29.94 U/L | Standard Deviation 11.72 |
| 90 Minutes Per Week | Change in Adenosine Deaminase Activity | Week 12 | 45.89 U/L | Standard Deviation 9.75 |
| 150 Minutes Per Week | Change in Adenosine Deaminase Activity | Week 12 | 37.83 U/L | Standard Deviation 10.51 |
| 150 Minutes Per Week | Change in Adenosine Deaminase Activity | Baseline | 31.83 U/L | Standard Deviation 5.84 |
| 150 Minutes Per Week | Change in Adenosine Deaminase Activity | Week 6 | 42.34 U/L | Standard Deviation 11.53 |
| 210 Minutes Per Week | Change in Adenosine Deaminase Activity | Week 6 | 45.03 U/L | Standard Deviation 9.05 |
| 210 Minutes Per Week | Change in Adenosine Deaminase Activity | Baseline | 25.91 U/L | Standard Deviation 8.45 |
| 210 Minutes Per Week | Change in Adenosine Deaminase Activity | Week 12 | 47.70 U/L | Standard Deviation 17.9 |
Primary
Change in Butyrylcholinesterase Activity
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Butyrylcholinesterase Activity | Baseline | 9.35 µmol BuSCh/h/mg of protein | Standard Deviation 2.79 |
| Control | Change in Butyrylcholinesterase Activity | Week 12 | 11.16 µmol BuSCh/h/mg of protein | Standard Deviation 1.65 |
| Control | Change in Butyrylcholinesterase Activity | Week 6 | 10.07 µmol BuSCh/h/mg of protein | Standard Deviation 0.83 |
| 90 Minutes Per Week | Change in Butyrylcholinesterase Activity | Baseline | 10.83 µmol BuSCh/h/mg of protein | Standard Deviation 2 |
| 90 Minutes Per Week | Change in Butyrylcholinesterase Activity | Week 12 | 9.49 µmol BuSCh/h/mg of protein | Standard Deviation 1.28 |
| 90 Minutes Per Week | Change in Butyrylcholinesterase Activity | Week 6 | 11.46 µmol BuSCh/h/mg of protein | Standard Deviation 2.83 |
| 150 Minutes Per Week | Change in Butyrylcholinesterase Activity | Week 6 | 9.40 µmol BuSCh/h/mg of protein | Standard Deviation 2.85 |
| 150 Minutes Per Week | Change in Butyrylcholinesterase Activity | Baseline | 7.44 µmol BuSCh/h/mg of protein | Standard Deviation 4.31 |
| 150 Minutes Per Week | Change in Butyrylcholinesterase Activity | Week 12 | 8.71 µmol BuSCh/h/mg of protein | Standard Deviation 1.78 |
| 210 Minutes Per Week | Change in Butyrylcholinesterase Activity | Baseline | 7.31 µmol BuSCh/h/mg of protein | Standard Deviation 4.23 |
| 210 Minutes Per Week | Change in Butyrylcholinesterase Activity | Week 12 | 10.34 µmol BuSCh/h/mg of protein | Standard Deviation 2.77 |
| 210 Minutes Per Week | Change in Butyrylcholinesterase Activity | Week 6 | 11.02 µmol BuSCh/h/mg of protein | Standard Deviation 2.83 |
Primary
Change in Glutathione Peroxidase Activity
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Glutathione Peroxidase Activity | Baseline | 87.32 U/mg protein | Standard Deviation 15.68 |
| Control | Change in Glutathione Peroxidase Activity | Week 12 | 93.08 U/mg protein | Standard Deviation 13.84 |
| Control | Change in Glutathione Peroxidase Activity | Week 6 | 90.24 U/mg protein | Standard Deviation 11.99 |
| 90 Minutes Per Week | Change in Glutathione Peroxidase Activity | Baseline | 63.69 U/mg protein | Standard Deviation 41.12 |
| 90 Minutes Per Week | Change in Glutathione Peroxidase Activity | Week 12 | 81.72 U/mg protein | Standard Deviation 12.52 |
| 90 Minutes Per Week | Change in Glutathione Peroxidase Activity | Week 6 | 91.26 U/mg protein | Standard Deviation 44.79 |
| 150 Minutes Per Week | Change in Glutathione Peroxidase Activity | Week 6 | 80.57 U/mg protein | Standard Deviation 43.76 |
| 150 Minutes Per Week | Change in Glutathione Peroxidase Activity | Baseline | 73.53 U/mg protein | Standard Deviation 40.56 |
| 150 Minutes Per Week | Change in Glutathione Peroxidase Activity | Week 12 | 80.04 U/mg protein | Standard Deviation 18.26 |
| 210 Minutes Per Week | Change in Glutathione Peroxidase Activity | Baseline | 65.31 U/mg protein | Standard Deviation 29.52 |
| 210 Minutes Per Week | Change in Glutathione Peroxidase Activity | Week 12 | 77.32 U/mg protein | Standard Deviation 13.01 |
| 210 Minutes Per Week | Change in Glutathione Peroxidase Activity | Week 6 | 98.87 U/mg protein | Standard Deviation 33.17 |
Primary
Change in Interleukin-6
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Change in Interleukin-6 | Week 12 | 4.47 pg/mL |
| Control | Change in Interleukin-6 | Week 6 | 3.62 pg/mL |
| Control | Change in Interleukin-6 | Baseline | 4.60 pg/mL |
| 90 Minutes Per Week | Change in Interleukin-6 | Week 12 | 3.82 pg/mL |
| 90 Minutes Per Week | Change in Interleukin-6 | Week 6 | 4.14 pg/mL |
| 90 Minutes Per Week | Change in Interleukin-6 | Baseline | 4.58 pg/mL |
| 150 Minutes Per Week | Change in Interleukin-6 | Baseline | 4.50 pg/mL |
| 150 Minutes Per Week | Change in Interleukin-6 | Week 12 | 4.71 pg/mL |
| 150 Minutes Per Week | Change in Interleukin-6 | Week 6 | 4.39 pg/mL |
| 210 Minutes Per Week | Change in Interleukin-6 | Week 12 | 5.55 pg/mL |
| 210 Minutes Per Week | Change in Interleukin-6 | Week 6 | 4.67 pg/mL |
| 210 Minutes Per Week | Change in Interleukin-6 | Baseline | 5.27 pg/mL |
Primary
Change in Superoxide Dismutase Activity
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Superoxide Dismutase Activity | Week 12 | 6.36 U/mg protein | Standard Deviation 0.31 |
| Control | Change in Superoxide Dismutase Activity | Baseline | 6.10 U/mg protein | Standard Deviation 1.33 |
| Control | Change in Superoxide Dismutase Activity | Week 6 | 6.04 U/mg protein | Standard Deviation 0.62 |
| 90 Minutes Per Week | Change in Superoxide Dismutase Activity | Week 6 | 5.04 U/mg protein | Standard Deviation 1.67 |
| 90 Minutes Per Week | Change in Superoxide Dismutase Activity | Baseline | 5.31 U/mg protein | Standard Deviation 0.79 |
| 90 Minutes Per Week | Change in Superoxide Dismutase Activity | Week 12 | 4.79 U/mg protein | Standard Deviation 1.29 |
| 150 Minutes Per Week | Change in Superoxide Dismutase Activity | Week 12 | 4.86 U/mg protein | Standard Deviation 1.06 |
| 150 Minutes Per Week | Change in Superoxide Dismutase Activity | Baseline | 5.72 U/mg protein | Standard Deviation 1.44 |
| 150 Minutes Per Week | Change in Superoxide Dismutase Activity | Week 6 | 4.20 U/mg protein | Standard Deviation 0.79 |
| 210 Minutes Per Week | Change in Superoxide Dismutase Activity | Week 6 | 5.02 U/mg protein | Standard Deviation 1.15 |
| 210 Minutes Per Week | Change in Superoxide Dismutase Activity | Baseline | 4.67 U/mg protein | Standard Deviation 1.11 |
| 210 Minutes Per Week | Change in Superoxide Dismutase Activity | Week 12 | 4.78 U/mg protein | Standard Deviation 1.46 |
Primary
Change in Thiobarbituric Acid Reactive Substances
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Thiobarbituric Acid Reactive Substances | Baseline | 0.100 nmol TBARS/mg protein | Standard Deviation 0.022 |
| Control | Change in Thiobarbituric Acid Reactive Substances | Week 12 | 0.073 nmol TBARS/mg protein | Standard Deviation 0.04 |
| Control | Change in Thiobarbituric Acid Reactive Substances | Week 6 | 0.119 nmol TBARS/mg protein | Standard Deviation 0.02 |
| 90 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Baseline | 0.144 nmol TBARS/mg protein | Standard Deviation 0.039 |
| 90 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Week 12 | 0.095 nmol TBARS/mg protein | Standard Deviation 0.02 |
| 90 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Week 6 | 0.159 nmol TBARS/mg protein | Standard Deviation 0.053 |
| 150 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Week 6 | 0.162 nmol TBARS/mg protein | Standard Deviation 0.049 |
| 150 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Baseline | 0.131 nmol TBARS/mg protein | Standard Deviation 0.028 |
| 150 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Week 12 | 0.062 nmol TBARS/mg protein | Standard Deviation 0.024 |
| 210 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Baseline | 0.137 nmol TBARS/mg protein | Standard Deviation 0.017 |
| 210 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Week 12 | 0.070 nmol TBARS/mg protein | Standard Deviation 0.019 |
| 210 Minutes Per Week | Change in Thiobarbituric Acid Reactive Substances | Week 6 | 0.149 nmol TBARS/mg protein | Standard Deviation 0.018 |
Primary
Change in Total Thiol Content
Time frame: Weeks 0, 6 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Total Thiol Content | Baseline | 9.00 nmol TNB/mg protein | Standard Deviation 1.45 |
| Control | Change in Total Thiol Content | Week 12 | 9.24 nmol TNB/mg protein | Standard Deviation 1.44 |
| Control | Change in Total Thiol Content | Week 6 | 12.26 nmol TNB/mg protein | Standard Deviation 2.5 |
| 90 Minutes Per Week | Change in Total Thiol Content | Baseline | 7.74 nmol TNB/mg protein | Standard Deviation 0.94 |
| 90 Minutes Per Week | Change in Total Thiol Content | Week 12 | 8.55 nmol TNB/mg protein | Standard Deviation 2.53 |
| 90 Minutes Per Week | Change in Total Thiol Content | Week 6 | 12.10 nmol TNB/mg protein | Standard Deviation 3.69 |
| 150 Minutes Per Week | Change in Total Thiol Content | Week 6 | 12.42 nmol TNB/mg protein | Standard Deviation 4.31 |
| 150 Minutes Per Week | Change in Total Thiol Content | Baseline | 7.73 nmol TNB/mg protein | Standard Deviation 1.85 |
| 150 Minutes Per Week | Change in Total Thiol Content | Week 12 | 7.80 nmol TNB/mg protein | Standard Deviation 1.51 |
| 210 Minutes Per Week | Change in Total Thiol Content | Baseline | 7.07 nmol TNB/mg protein | Standard Deviation 1.63 |
| 210 Minutes Per Week | Change in Total Thiol Content | Week 12 | 8.32 nmol TNB/mg protein | Standard Deviation 1.52 |
| 210 Minutes Per Week | Change in Total Thiol Content | Week 6 | 12.13 nmol TNB/mg protein | Standard Deviation 3.65 |
Secondary
Change in Handgrip Strength
Measured using a handgrip dynamometer and quantified in kilogram-force
Time frame: Weeks 0 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Handgrip Strength | Baseline | 23.61 kgf | Standard Deviation 3.91 |
| Control | Change in Handgrip Strength | Week 12 | 22.98 kgf | Standard Deviation 4.92 |
| 90 Minutes Per Week | Change in Handgrip Strength | Week 12 | 26.56 kgf | Standard Deviation 5.76 |
| 90 Minutes Per Week | Change in Handgrip Strength | Baseline | 23.80 kgf | Standard Deviation 5.46 |
| 150 Minutes Per Week | Change in Handgrip Strength | Baseline | 25.03 kgf | Standard Deviation 5.7 |
| 150 Minutes Per Week | Change in Handgrip Strength | Week 12 | 26.67 kgf | Standard Deviation 6.64 |
| 210 Minutes Per Week | Change in Handgrip Strength | Baseline | 24.81 kgf | Standard Deviation 4.23 |
| 210 Minutes Per Week | Change in Handgrip Strength | Week 12 | 30.39 kgf | Standard Deviation 4.19 |
Secondary
Change in Performance in the Six-minute Walk Test
Time frame: Weeks 0 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Performance in the Six-minute Walk Test | Baseline | 466.49 Meters | Standard Deviation 97.89 |
| Control | Change in Performance in the Six-minute Walk Test | Week 12 | 514.5 Meters | Standard Deviation 124.24 |
| 90 Minutes Per Week | Change in Performance in the Six-minute Walk Test | Week 12 | 581.02 Meters | Standard Deviation 76.02 |
| 90 Minutes Per Week | Change in Performance in the Six-minute Walk Test | Baseline | 515.78 Meters | Standard Deviation 69.08 |
| 150 Minutes Per Week | Change in Performance in the Six-minute Walk Test | Baseline | 552.62 Meters | Standard Deviation 62.29 |
| 150 Minutes Per Week | Change in Performance in the Six-minute Walk Test | Week 12 | 559.57 Meters | Standard Deviation 53.03 |
| 210 Minutes Per Week | Change in Performance in the Six-minute Walk Test | Baseline | 539.77 Meters | Standard Deviation 46.17 |
| 210 Minutes Per Week | Change in Performance in the Six-minute Walk Test | Week 12 | 586.69 Meters | Standard Deviation 66.53 |
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.
Time frame: Week 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Age | 70 years |
| 90 Minutes Per Week | Age | 62 years |
| 150 Minutes Per Week | Age | 61.5 years |
| 210 Minutes Per Week | Age | 63 years |
Other Pre-specified
Change in Body Mass Index
Time frame: Weeks 0 and 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Change in Body Mass Index | Baseline | 29.69 kg/m² |
| Control | Change in Body Mass Index | Week 12 | 28.09 kg/m² |
| 90 Minutes Per Week | Change in Body Mass Index | Week 12 | 28.03 kg/m² |
| 90 Minutes Per Week | Change in Body Mass Index | Baseline | 28.25 kg/m² |
| 150 Minutes Per Week | Change in Body Mass Index | Baseline | 28.62 kg/m² |
| 150 Minutes Per Week | Change in Body Mass Index | Week 12 | 28.97 kg/m² |
| 210 Minutes Per Week | Change in Body Mass Index | Baseline | 29.56 kg/m² |
| 210 Minutes Per Week | Change in Body Mass Index | Week 12 | 28.20 kg/m² |
Other Pre-specified
Change in Calories Intake
Measured by a 24-hour food recall and quantified in calories
Time frame: Weeks 0 and 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Calories Intake | Baseline | 1700.45 cal | Standard Deviation 178.56 |
| Control | Change in Calories Intake | Week 12 | 1873.03 cal | Standard Deviation 531.22 |
| 90 Minutes Per Week | Change in Calories Intake | Week 12 | 1720.32 cal | Standard Deviation 534.82 |
| 90 Minutes Per Week | Change in Calories Intake | Baseline | 1390.64 cal | Standard Deviation 687 |
| 150 Minutes Per Week | Change in Calories Intake | Week 12 | 1229.61 cal | Standard Deviation 550.19 |
| 150 Minutes Per Week | Change in Calories Intake | Baseline | 1461.53 cal | Standard Deviation 544.92 |
| 210 Minutes Per Week | Change in Calories Intake | Week 12 | 1322.39 cal | Standard Deviation 317.85 |
| 210 Minutes Per Week | Change in Calories Intake | Baseline | 1485.54 cal | Standard Deviation 474.46 |
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
Time frame: Week 0 and 12
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Change in Minutes Per Week of Physical Activity Out of Intervention | Baseline | 30 minutes per week |
| Control | Change in Minutes Per Week of Physical Activity Out of Intervention | Week 12 | 90 minutes per week |
| 90 Minutes Per Week | Change in Minutes Per Week of Physical Activity Out of Intervention | Week 12 | 90 minutes per week |
| 90 Minutes Per Week | Change in Minutes Per Week of Physical Activity Out of Intervention | Baseline | 35 minutes per week |
| 150 Minutes Per Week | Change in Minutes Per Week of Physical Activity Out of Intervention | Baseline | 60 minutes per week |
| 150 Minutes Per Week | Change in Minutes Per Week of Physical Activity Out of Intervention | Week 12 | 65 minutes per week |
| 210 Minutes Per Week | Change in Minutes Per Week of Physical Activity Out of Intervention | Baseline | 150 minutes per week |
| 210 Minutes Per Week | Change in Minutes Per Week of Physical Activity Out of Intervention | Week 12 | 150 minutes per week |
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.
Time frame: Week 0
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Chronic Use of Medication | No | 0 participants |
| Control | Chronic Use of Medication | Yes | 9 participants |
| 90 Minutes Per Week | Chronic Use of Medication | Yes | 9 participants |
| 90 Minutes Per Week | Chronic Use of Medication | No | 1 participants |
| 150 Minutes Per Week | Chronic Use of Medication | No | 1 participants |
| 150 Minutes Per Week | Chronic Use of Medication | Yes | 9 participants |
| 210 Minutes Per Week | Chronic Use of Medication | No | 1 participants |
| 210 Minutes Per Week | Chronic Use of Medication | Yes | 10 participants |
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.
Time frame: Week 0
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | Educational Level | Incomplete primary school | 1 participants |
| Control | Educational Level | Higher education | 1 participants |
| Control | Educational Level | Primary school | 3 participants |
| Control | Educational Level | High school | 3 participants |
| Control | Educational Level | Incomplete higher education | 0 participants |
| Control | Educational Level | Incomplete high school | 1 participants |
| 90 Minutes Per Week | Educational Level | Incomplete higher education | 0 participants |
| 90 Minutes Per Week | Educational Level | Higher education | 1 participants |
| 90 Minutes Per Week | Educational Level | Incomplete primary school | 4 participants |
| 90 Minutes Per Week | Educational Level | High school | 1 participants |
| 90 Minutes Per Week | Educational Level | Primary school | 3 participants |
| 90 Minutes Per Week | Educational Level | Incomplete high school | 1 participants |
| 150 Minutes Per Week | Educational Level | Primary school | 1 participants |
| 150 Minutes Per Week | Educational Level | Incomplete higher education | 0 participants |
| 150 Minutes Per Week | Educational Level | High school | 4 participants |
| 150 Minutes Per Week | Educational Level | Incomplete high school | 2 participants |
| 150 Minutes Per Week | Educational Level | Incomplete primary school | 3 participants |
| 150 Minutes Per Week | Educational Level | Higher education | 0 participants |
| 210 Minutes Per Week | Educational Level | Higher education | 1 participants |
| 210 Minutes Per Week | Educational Level | Incomplete higher education | 2 participants |
| 210 Minutes Per Week | Educational Level | Incomplete primary school | 4 participants |
| 210 Minutes Per Week | Educational Level | Primary school | 2 participants |
| 210 Minutes Per Week | Educational Level | Incomplete high school | 0 participants |
| 210 Minutes Per Week | Educational Level | High school | 2 participants |
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.
Time frame: Week 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Household Income | 846 US$ |
| 90 Minutes Per Week | Household Income | 538 US$ |
| 150 Minutes Per Week | Household Income | 867 US$ |
| 210 Minutes Per Week | Household Income | 423 US$ |