NCT02681744

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 15, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

February 10, 2016

Last Update Submit

February 11, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Laboratorial Body Composition assessment (DXA)

    DXA-derived body fat and DXA-derived fat free mass

    30 minutes

Secondary Outcomes (1)

  • Isokinetic peak torque of leg extension (dynamometer isokinetic)

    20 minutes

Study Arms (2)

Control Group

NO INTERVENTION

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 group

EXPERIMENTAL

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.

Behavioral: Resistance Training

Interventions

24-weeks of progressive strength training

Also known as: Strength Training
Experimental group

Eligibility Criteria

Age60 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Educação Física

Brasília, Federal District, 70910900, Brazil

RECRUITING

MeSH Terms

Conditions

SarcopeniaObesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ricardo M Lima, PhD

    University of Brasilia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo M Lima, PhD

CONTACT

André B Gadelha, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 12, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 15, 2016

Record last verified: 2016-02

Locations