The Effect of Different Volumes of Physical Exercise on the Immune System (ProAFIM)

Dose-response Effects of Different Volumes of Structured Exercise in the Inflammatory and Oxidative Stress Parameters in Postmenopausal Women: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Immune System Diseases; Oxidative Stress
• Intervention / Treatment: Behavioral: Physical exercise intervention

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Federal University of Pelotas
• Investigators: Principal Investigator: Matheus P Freitas, Federal University of Pelotas

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: January 2, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases
• Other Study ID Numbers: 27371214.4.0000.5313