ProAFIM: The Effect of Different Volumes of Physical Exercise on the Immune System
Sponsor
Federal University of Pelotas (Other)
Overall Status
Completed
CT.gov ID
NCT02331446
Collaborator
(none)
42
4
6
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Study Type:
Interventional
Actual Enrollment
:
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Dose-response Effects of Different Volumes of Structured Exercise in the Inflammatory and Oxidative Stress Parameters in Postmenopausal Women: a Randomized Clinical Trial
Study Start Date
:
Mar 1, 2014
Actual Primary Completion Date
:
Sep 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control The control group will be oriented to maintain their normal activity and habits and will not receive the intervention. |
|
| Experimental: 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. |
Behavioral: Physical exercise intervention
|
| Experimental: 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. |
Behavioral: Physical exercise intervention
|
| Experimental: 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. |
Behavioral: Physical exercise intervention
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 Outcome Measures
- Change in Body Mass Index [Weeks 0 and 12]
- 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 Calories Intake [Weeks 0 and 12]
Measured by a 24-hour food recall and quantified in calories
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts 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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Federal University of Pelotas
Investigators
- Principal Investigator: Matheus P Freitas, Federal University of Pelotas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Matheus Pintanel Silva de Freitas,
Masters course student,
Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT02331446
Other Study ID Numbers:
- 27371214.4.0000.5313
First Posted:
Jan 6, 2015
Last Update Posted:
Sep 29, 2016
Last Verified:
Aug 1, 2016
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Period Title: Overall Study | ||||
| STARTED | 9 | 11 | 11 | 11 |
| COMPLETED | 5 | 6 | 8 | 8 |
| NOT COMPLETED | 4 | 5 | 3 | 3 |
Baseline Characteristics
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 | Total of all reporting groups |
| Overall Participants | 9 | 10 | 10 | 11 | 40 |
| Age (years) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [years] |
70
|
62
|
61.5
|
63
|
63
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
9
100%
|
10
100%
|
10
100%
|
11
100%
|
40
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
22.2%
|
2
20%
|
2
20%
|
3
27.3%
|
9
22.5%
|
| White |
7
77.8%
|
8
80%
|
8
80%
|
8
72.7%
|
31
77.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| Brazil |
9
100%
|
10
100%
|
10
100%
|
11
100%
|
40
100%
|
| Household Income (US$) [Median (Inter-Quartile Range) ] | |||||
| Median (Inter-Quartile Range) [US$] |
846
|
538
|
867
|
423
|
612
|
| Resting heart rate (bpm) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [bpm] |
65.8
(7.9)
|
64.7
(13.1)
|
64.5
(9.2)
|
68.1
(12.1)
|
65.5
(10.6)
|
| Systolic blood pressure (mmHg) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mmHg] |
119.8
(6.7)
|
118.2
(20.4)
|
121.2
(12.4)
|
121.0
(14.2)
|
120.8
(14.3)
|
| Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [mmHg] |
74.4
(8.8)
|
75.2
(17.2)
|
76.0
(7.0)
|
78.7
(7.1)
|
76.4
(10.6)
|
| Marital status (participants) [Number] | |||||
| Married |
4
44.4%
|
4
40%
|
7
70%
|
1
9.1%
|
16
40%
|
| Others |
5
55.6%
|
6
60%
|
3
30%
|
10
90.9%
|
24
60%
|
| Educational level (participants) [Number] | |||||
| Incomplete primary school |
1
11.1%
|
4
40%
|
3
30%
|
4
36.4%
|
12
30%
|
| Primary school |
3
33.3%
|
3
30%
|
1
10%
|
2
18.2%
|
9
22.5%
|
| Incomplete high school |
1
11.1%
|
1
10%
|
2
20%
|
0
0%
|
4
10%
|
| High school |
3
33.3%
|
1
10%
|
4
40%
|
2
18.2%
|
10
25%
|
| Incomplete higher education |
0
0%
|
0
0%
|
0
0%
|
2
18.2%
|
2
5%
|
| Higher education |
1
11.1%
|
1
10%
|
0
0%
|
1
9.1%
|
3
7.5%
|
| Chronic Use of Medication (participants) [Number] | |||||
| No |
0
0%
|
1
10%
|
1
10%
|
1
9.1%
|
3
7.5%
|
| Yes |
9
100%
|
9
90%
|
9
90%
|
10
90.9%
|
37
92.5%
|
| Smoking (participants) [Number] | |||||
| No |
8
88.9%
|
8
80%
|
9
90%
|
10
90.9%
|
35
87.5%
|
| Yes |
1
11.1%
|
2
20%
|
1
10%
|
1
9.1%
|
5
12.5%
|
| Alcohol intake (participants) [Number] | |||||
| Daily (one dose) |
0
0%
|
0
0%
|
1
10%
|
0
0%
|
1
2.5%
|
| Sporadically |
5
55.6%
|
4
40%
|
7
70%
|
5
45.5%
|
21
52.5%
|
| No |
4
44.4%
|
6
60%
|
2
20%
|
6
54.5%
|
18
45%
|
Outcome Measures
| Title | Change in Interleukin-6 |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
4.60
|
4.58
|
4.50
|
5.27
|
| Week 6 |
3.62
|
4.14
|
4.39
|
4.67
|
| Week 12 |
4.47
|
3.82
|
4.71
|
5.55
|
| Title | Change in Adenosine Deaminase Activity |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
31.12
(5.96)
|
29.94
(11.72)
|
31.83
(5.84)
|
25.91
(8.45)
|
| Week 6 |
42.11
(10.74)
|
42.54
(10.07)
|
42.34
(11.53)
|
45.03
(9.05)
|
| Week 12 |
43.11
(20.21)
|
45.89
(9.75)
|
37.83
(10.51)
|
47.70
(17.90)
|
| Title | Change in Butyrylcholinesterase Activity |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
9.35
(2.79)
|
10.83
(2.00)
|
7.44
(4.31)
|
7.31
(4.23)
|
| Week 6 |
10.07
(0.83)
|
11.46
(2.83)
|
9.40
(2.85)
|
11.02
(2.83)
|
| Week 12 |
11.16
(1.65)
|
9.49
(1.28)
|
8.71
(1.78)
|
10.34
(2.77)
|
| Title | Change in Thiobarbituric Acid Reactive Substances |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
0.100
(0.022)
|
0.144
(0.039)
|
0.131
(0.028)
|
0.137
(0.017)
|
| Week 6 |
0.119
(0.020)
|
0.159
(0.053)
|
0.162
(0.049)
|
0.149
(0.018)
|
| Week 12 |
0.073
(0.040)
|
0.095
(0.020)
|
0.062
(0.024)
|
0.070
(0.019)
|
| Title | Change in Total Thiol Content |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
9.00
(1.45)
|
7.74
(0.94)
|
7.73
(1.85)
|
7.07
(1.63)
|
| Week 6 |
12.26
(2.50)
|
12.10
(3.69)
|
12.42
(4.31)
|
12.13
(3.65)
|
| Week 12 |
9.24
(1.44)
|
8.55
(2.53)
|
7.80
(1.51)
|
8.32
(1.52)
|
| Title | Change in Glutathione Peroxidase Activity |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
87.32
(15.68)
|
63.69
(41.12)
|
73.53
(40.56)
|
65.31
(29.52)
|
| Week 6 |
90.24
(11.99)
|
91.26
(44.79)
|
80.57
(43.76)
|
98.87
(33.17)
|
| Week 12 |
93.08
(13.84)
|
81.72
(12.52)
|
80.04
(18.26)
|
77.32
(13.01)
|
| Title | Change in Performance in the Six-minute Walk Test |
|---|---|
| Description | |
| Time Frame | Weeks 0 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
466.49
(97.89)
|
515.78
(69.08)
|
552.62
(62.29)
|
539.77
(46.17)
|
| Week 12 |
514.5
(124.24)
|
581.02
(76.02)
|
559.57
(53.03)
|
586.69
(66.53)
|
| Title | Change in Handgrip Strength |
|---|---|
| Description | Measured using a handgrip dynamometer and quantified in kilogram-force |
| Time Frame | Weeks 0 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
23.61
(3.91)
|
23.80
(5.46)
|
25.03
(5.70)
|
24.81
(4.23)
|
| Week 12 |
22.98
(4.92)
|
26.56
(5.76)
|
26.67
(6.64)
|
30.39
(4.19)
|
| Title | Change in Body Mass Index |
|---|---|
| Description | |
| Time Frame | Weeks 0 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
29.69
|
28.25
|
28.62
|
29.56
|
| Week 12 |
28.09
|
28.03
|
28.97
|
28.20
|
| Title | Change in Minutes Per Week of Physical Activity Out of Intervention |
|---|---|
| Description | Measured by the commuting and leisure sections of the International Physical Activity Questionnaire |
| Time Frame | Week 0 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
30
|
35
|
60
|
150
|
| Week 12 |
90
|
90
|
65
|
150
|
| Title | Change in Calories Intake |
|---|---|
| Description | Measured by a 24-hour food recall and quantified in calories |
| Time Frame | Weeks 0 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
1700.45
(178.56)
|
1390.64
(687.00)
|
1461.53
(544.92)
|
1485.54
(474.46)
|
| Week 12 |
1873.03
(531.22)
|
1720.32
(534.82)
|
1229.61
(550.19)
|
1322.39
(317.85)
|
| Title | Educational Level |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 9 | 10 | 10 | 11 |
| Incomplete primary school |
1
11.1%
|
4
40%
|
3
30%
|
4
36.4%
|
| Primary school |
3
33.3%
|
3
30%
|
1
10%
|
2
18.2%
|
| Incomplete high school |
1
11.1%
|
1
10%
|
2
20%
|
0
0%
|
| High school |
3
33.3%
|
1
10%
|
4
40%
|
2
18.2%
|
| Incomplete higher education |
0
0%
|
0
0%
|
0
0%
|
2
18.2%
|
| Higher education |
1
11.1%
|
1
10%
|
0
0%
|
1
9.1%
|
| Title | Household Income |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 9 | 10 | 10 | 11 |
| Median (Inter-Quartile Range) [US$] |
846
|
538
|
867
|
423
|
| Title | Age |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 9 | 10 | 10 | 11 |
| Median (Inter-Quartile Range) [years] |
70
|
62
|
61.5
|
63
|
| Title | Chronic Use of Medication |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 9 | 10 | 10 | 11 |
| No |
0
0%
|
1
10%
|
1
10%
|
1
9.1%
|
| Yes |
9
100%
|
9
90%
|
9
90%
|
10
90.9%
|
| Title | Change in Superoxide Dismutase Activity |
|---|---|
| Description | |
| Time Frame | Weeks 0, 6 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week |
|---|---|---|---|---|
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 |
| Measure Participants | 5 | 6 | 8 | 8 |
| Baseline |
6.10
(1.33)
|
5.31
(0.79)
|
5.72
(1.44)
|
4.67
(1.11)
|
| Week 6 |
6.04
(0.62)
|
5.04
(1.67)
|
4.20
(0.79)
|
5.02
(1.15)
|
| Week 12 |
6.36
(0.31)
|
4.79
(1.29)
|
4.86
(1.06)
|
4.78
(1.46)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week | ||||
| Arm/Group Description | 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. Physical exercise intervention | 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 | 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 | ||||
All Cause Mortality |
||||||||
| Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Control | 90 Minutes Per Week | 150 Minutes Per Week | 210 Minutes Per Week | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) | ||||
Limitations/Caveats
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.
More Information
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 | Msc. Matheus Pintanel Freitas |
|---|---|
| Organization | Federal Universisty of Pelotas |
| Phone | |
| matheus.pintanel@hotmail.com |
Responsible Party:
Matheus Pintanel Silva de Freitas,
Masters course student,
Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT02331446
Other Study ID Numbers:
- 27371214.4.0000.5313
First Posted:
Jan 6, 2015
Last Update Posted:
Sep 29, 2016
Last Verified:
Aug 1, 2016