- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02681744
Sarcopenia, Obesity, and Resistance Training
February 11, 2016 updated by: Ricardo Moreno Lima, University of Brasilia
Effects of Resistance Training on Sarcopenic Obesity Index in Older Women: a RCT.
The purpose of this study was to examine the effects of resistance training on sarcopenic obesity in older women.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Anticipated)
244
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ricardo M Lima, PhD
- Phone Number: +556184908490
- Email: gefsunb@gmail.com
Study Contact Backup
- Name: André B Gadelha, MSc
- Phone Number: +556181880231
- Email: andrebonadias@gmail.com
Study Locations
-
-
Distrito Federal
-
Brasília, Distrito Federal, Brazil, 70910900
- Recruiting
- Faculdade de Educação Física
-
Contact:
- Silvia G Neri, MSc
- Phone Number: +556182055934
- Email: silvia_grn@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
These participants will be instructed to maintain their habits during 24 weeks.
Before and after the aforementioned period, they will be asked to perform body composition and strength assessments, using DXA and isokinetic dynamometer, respectively.
|
|
Experimental: Experimental group
Participants from the experimental group will assign to the resistance training program undergo physician screening at rest and under cardiopulmonary exercise test conditions before starting the program.
Following a three-week familiarization process, participants undergo one repetition maximum (1-RM) testing for each of the exercises of the training program.
This procedure intended to determine exercise load and will be systematically repeated in four-week intervals.
Volunteers will train thrice per week during 24 weeks.
The training program will involve the following exercises: chest press, lat pulldown, knee extension, hamstrings curl, leg press, hip abduction.
|
24-weeks of progressive strength training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Laboratorial Body Composition assessment (DXA)
Time Frame: 30 minutes
|
DXA-derived body fat and DXA-derived fat free mass
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isokinetic peak torque of leg extension (dynamometer isokinetic)
Time Frame: 20 minutes
|
Dominant leg extension peak torque will be recorded in three sets of maximal effort
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ricardo M Lima, PhD, University of Brasilia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
February 10, 2016
First Submitted That Met QC Criteria
February 10, 2016
First Posted (Estimate)
February 12, 2016
Study Record Updates
Last Update Posted (Estimate)
February 15, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 487622/2012-0 (Other Grant/Funding Number: CNPq)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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