Oxidative Stress Clinical Trial
— ProAFIMOfficial title:
Dose-response Effects of Different Volumes of Structured Exercise in the Inflammatory and Oxidative Stress Parameters in Postmenopausal Women: a Randomized Clinical Trial
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 |
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Federal University of Pelotas |
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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