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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02681744
Other study ID # 487622/2012-0
Secondary ID
Status Recruiting
Phase N/A
First received February 10, 2016
Last updated February 11, 2016
Start date February 2016
Est. completion date August 2016

Study information

Verified date February 2016
Source University of Brasilia
Contact Ricardo M Lima, PhD
Phone +556184908490
Email gefsunb@gmail.com
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women.


Description:

To examine the effects of resistance training on sarcopenic obesity in older women, a representative sample of older women from Brasília, Brazil (n>244 subjects), will be recruited and invited to undergo body composition measurement using dual-energy x-ray absorptiometry. Moreover, the Sarcopenic Obesity index and isokinetic strength evaluations will be performed. It will be a single-blind randomized, controlled 24-week clinical trial, in which experimental group will receive a progressive resistance training program, meanwhile control group will receive instructions to maintain their lifestyle habits. Randomization will be conducted by computer-generated list in blocks of 10. Additionally, body composition, strength assessment, and sarcopenic index will collected and compared after the intervention period.


Recruitment information / eligibility

Status Recruiting
Enrollment 244
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- Community older women (aged between 60 and 80 years).

Exclusion Criteria:

- individuals with any metallic implant or artificial pacemaker, who had undergone hip surgery, who were unable to walk without assistance and those affected by metabolic or endocrine disorders that affect the muscular system.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Resistance Training
24-weeks of progressive strength training

Locations

Country Name City State
Brazil Faculdade de Educação Física Brasília Distrito Federal

Sponsors (1)

Lead Sponsor Collaborator
University of Brasilia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Laboratorial Body Composition assessment (DXA) DXA-derived body fat and DXA-derived fat free mass 30 minutes Yes
Secondary Isokinetic peak torque of leg extension (dynamometer isokinetic) Dominant leg extension peak torque will be recorded in three sets of maximal effort 20 minutes Yes
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