- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02434185
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
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-
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Murcia, Spain, 30107
- Catholic University of Murcia
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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
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
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.
Investigators
- 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.
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
March 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
April 30, 2015
First Submitted That Met QC Criteria
April 30, 2015
First Posted (Estimate)
May 5, 2015
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 10, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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