The Effect of Different Volumes of Physical Exercise on the Immune System

Oxidative Stress Clinical Trial

— ProAFIM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331446
• Other study ID #: 27371214.4.0000.5313
• Status: Completed
• Phase: N/A
• First received: December 23, 2014
• Last updated: January 2, 2015
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Immune System Diseases
• Oxidative Stress

Intervention

Behavioral:
• Physical exercise intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Pelotas

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Body Mass Index		Weeks 0 and 12	Yes
Other	Change in kilocalories intake	Measured by a 24-hour food recall and quantified in kilocalories	Weeks 0, 6 and 12	Yes
Other	Educational level	Measured by a questionnaire and quantified in complete years of study	Week 0	Yes
Other	Family income	Measured by a questionnaire and quantified by the salary of all persons in the study participant's home	Week 0	Yes
Other	Age		Week 0	Yes
Other	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, 6 and 12	Yes
Other	Continuous use of drugs	Measured by a questionnaire and quantified by the name of the medicines people use	Week 0	Yes
Primary	Change in Interleukin-6		Weeks 0, 6 and 12	Yes
Primary	Change in adenosine deaminase activity		Weeks 0, 6 and 12	Yes
Primary	Change in thiobarbituric acid reactive substances		Weeks 0, 6 and 12	Yes
Primary	Change in total thiol content		Weeks 0, 6 and 12	Yes
Primary	Change in Catalase activity		Weeks 0, 6 and 12	Yes
Primary	Change in superoxide dismutase activity		Weeks 0, 6 and 12	Yes
Secondary	Change in performance in the six-minute walk test		Weeks 0, 6 and 12	Yes
Secondary	Change in handgrip strength	Measured using a handgrip dynamometer and quantified in kilogram-force	Weeks 0, 6 and 12	Yes