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Sarcopenia, Obesity, and Resistance Training

Primary Purpose

Sarcopenia, Aging, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Resistance Training
Sponsored by
University of Brasilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcopenia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculdade de Educação FísicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Experimental group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Laboratorial Body Composition assessment (DXA)
DXA-derived body fat and DXA-derived fat free mass

Secondary Outcome Measures

Isokinetic peak torque of leg extension (dynamometer isokinetic)
Dominant leg extension peak torque will be recorded in three sets of maximal effort

Full Information

First Posted
February 10, 2016
Last Updated
February 11, 2016
Sponsor
University of Brasilia
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1. Study Identification

Unique Protocol Identification Number
NCT02681744
Brief Title
Sarcopenia, Obesity, and Resistance Training
Official Title
Effects of Resistance Training on Sarcopenic Obesity Index in Older Women: a RCT.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Aging, Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resistance Training
Other Intervention Name(s)
Strength Training
Intervention Description
24-weeks of progressive strength training
Primary Outcome Measure Information:
Title
Laboratorial Body Composition assessment (DXA)
Description
DXA-derived body fat and DXA-derived fat free mass
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Isokinetic peak torque of leg extension (dynamometer isokinetic)
Description
Dominant leg extension peak torque will be recorded in three sets of maximal effort
Time Frame
20 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo M Lima, PhD
Phone
+556184908490
Email
gefsunb@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
André B Gadelha, MSc
Phone
+556181880231
Email
andrebonadias@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo M Lima, PhD
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Educação Física
City
Brasília
State/Province
Distrito Federal
ZIP/Postal Code
70910900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia G Neri, MSc
Phone
+556182055934
Email
silvia_grn@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sarcopenia, Obesity, and Resistance Training

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