NCT Number: NCT02331446
The Effect of Different Volumes of Physical Exercise on the Immune System
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.
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Notify MeKey information
Conditions
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Change in Interleukin-6
Time frame: Weeks 0, 6 and 12
-
Change in Adenosine Deaminase Activity
Time frame: Weeks 0, 6 and 12
-
Change in Butyrylcholinesterase Activity
Time frame: Weeks 0, 6 and 12
-
Change in Thiobarbituric Acid Reactive Substances
Time frame: Weeks 0, 6 and 12
-
Change in Total Thiol Content
Time frame: Weeks 0, 6 and 12
-
Change in Glutathione Peroxidase Activity
Time frame: Weeks 0, 6 and 12
-
Change in Superoxide Dismutase Activity
Time frame: Weeks 0, 6 and 12
Secondary outcomes
-
Change in Performance in the Six-minute Walk Test
Time frame: Weeks 0 and 12
-
Change in Handgrip Strength
Time frame: Weeks 0 and 12
Measured using a handgrip dynamometer and quantified in kilogram-force
Other outcomes
-
Change in Body Mass Index
Time frame: Weeks 0 and 12
-
Change in Minutes Per Week of Physical Activity Out of Intervention
Time frame: Week 0 and 12
Measured by the commuting and leisure sections of the International Physical Activity Questionnaire
-
Change in Calories Intake
Time frame: Weeks 0 and 12
Measured by a 24-hour food recall and quantified in calories
-
Educational Level
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Sponsors and collaborators
Lead sponsor
Federal University of Pelotas
Other
Registry information
Official study title
Dose-response Effects of Different Volumes of Structured Exercise in the Inflammatory and Oxidative Stress Parameters in Postmenopausal Women: a Randomized Clinical Trial
Acronym: ProAFIM
Important dates
- Study start
- 2014
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Jan 6, 2015
- Registry last updated
- Sep 29, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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