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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02331446
Other study ID # 27371214.4.0000.5313
Secondary ID
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


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
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