The Bilateral Deficit Phenomenon, Functional and Dynamometric Assessment in Postmenopausal Women

October 10, 2018 updated by: Juan Diego Ruiz-Cárdenas, Universidad Católica San Antonio de Murcia
The bilateral deficit phenomenon (BLD) is defined as an inability of the neuromuscular system to generate maximal force when two homonymous limb operate simultaneously (bilateral contraction) with respect to the force developed when both limbs acts separately (unilateral contraction). From an applied perspective, movement patterns of bilateral homonymous limb are often developed during activities of day living, e.g. rising from a chair or opening a jar. The BLD can be considered an intrinsic property of the human neuromuscular system but could be enough important to constitute a performance-limiting factor for postmenopausal women that involves a degenerative loss of muscular strength. Therefore, a specific analysis of this phenomenon and its relation with activities of daily living, such as climbing a step and rising from a chair, is crucial for detecting variables of neuromuscular performance and develop strategies to minimize the loss of strength.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  • 20 postmenopausal women unexperience in strength training or resistance training, without musculoskeletal, neurological diseases, and cardiovascular limiting-diseases were recruited.
  • Maximum strength of lower limbs during leg-press exercise was measured for future analysis.
  • The force-time curves were measured during climbing a step and rising from a chair.
  • A fragility phenotype test was applied to the subjects to determine frailty phenotype classification, including; weight loss of greater than 10 lbs in the past 12 months, maximal handgrip strength, time to walk 15-ft at usual pace, self-reported leisure time physical activity, and self-reported exhaustion.
  • The anthropometric measurements were performed by dual energy X-ray absorptiometry.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • Catholic University of Murcia

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal women not experienced in strength training or resistance, without musculoskeletal, neurological diseases, and cardiovascular limiting-factor.

Description

Inclusion Criteria:

  • Postmenopausal women

Exclusion Criteria:

  • Unexperienced in strength training or resistance training.
  • Not musculoskeletal diseases.
  • Not neurological diseases.
  • Not cardiovascular limiting-diseases.
  • Not fragility or pre-fragility phenotype.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Assess the maximum force of lower limbs during bilateral and unilateral contraction
Time Frame: Screening visit
Screening visit
Assess the force-time curve during climbing a step
Time Frame: Screening visit
Screening visit
Assess the force-time curve during climbing rising from a chair
Time Frame: Screening visit
Screening visit
Assess bone mineral-free lean tissue mass by dual energy X-ray absorptiometry
Time Frame: Screening visit
Screening visit
Assess the fragility phenotype of the subjects
Time Frame: Screening visit
Screening visit
Assess the rate of force developed in time intervals (0-50, 50-100, 100-150ms) of lower limbs during bilateral and unilateral contraction
Time Frame: Screening visit
Screening visit
Assess fat-tissue mass and lean-tissue mass composition
Time Frame: Screening visit
Screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juan Diego JD Ruiz-Cárdenas, BSc, MSc, Universidad Católica San Antonio de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UCAM-BLD-1

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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