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Completed

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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Key information

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

Physical Exercise Intervention

Behavioral

Primary outcomes

  1. Change in Interleukin-6

    Time frame: Weeks 0, 6 and 12

  2. Change in Adenosine Deaminase Activity

    Time frame: Weeks 0, 6 and 12

  3. Change in Butyrylcholinesterase Activity

    Time frame: Weeks 0, 6 and 12

  4. Change in Thiobarbituric Acid Reactive Substances

    Time frame: Weeks 0, 6 and 12

  5. Change in Total Thiol Content

    Time frame: Weeks 0, 6 and 12

  6. Change in Glutathione Peroxidase Activity

    Time frame: Weeks 0, 6 and 12

  7. Change in Superoxide Dismutase Activity

    Time frame: Weeks 0, 6 and 12

Secondary outcomes

  1. Change in Performance in the Six-minute Walk Test

    Time frame: Weeks 0 and 12

  2. Change in Handgrip Strength

    Time frame: Weeks 0 and 12

    Measured using a handgrip dynamometer and quantified in kilogram-force

Other outcomes

  1. Change in Body Mass Index

    Time frame: Weeks 0 and 12

  2. 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

  3. Change in Calories Intake

    Time frame: Weeks 0 and 12

    Measured by a 24-hour food recall and quantified in calories

  4. 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.

  5. 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.

  6. 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.

  7. 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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