Postmenopausal SyndromeNCT02434185
The Bilateral Deficit Phenomenon, Functional and Dynamometric Assessment in Postmenopausal Women
An observational study of Postmenopausal Syndrome and Muscle Weakness, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Syndrome, Muscle Weakness
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Postmenopausal women not experienced in strength training or resistance, without musculoskeletal, neurological diseases, and cardiovascular limiting-factor.
Who may be able to join
- Postmenopausal women
Who cannot join
- Unexperienced in strength training or resistance training.
- Not musculoskeletal diseases.
- Not neurological diseases.
- Not cardiovascular limiting-diseases.
- Not fragility or pre-fragility phenotype.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Postmenopausal Syndrome, Muscle Weakness
- Keywords
- Musculoskeletal Physiological Phenomena, Postmenopause, Muscle Strength, Absorptiometry, Photon
- Medical subject headings
- Muscle Weakness
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the maximum force of lower limbs during bilateral and unilateral contraction
Measured: Screening visit
Assess the force-time curve during climbing a step
Measured: Screening visit
Assess the force-time curve during climbing rising from a chair
Measured: Screening visit
Assess bone mineral-free lean tissue mass by dual energy X-ray absorptiometry
Measured: Screening visit
Assess the fragility phenotype of the subjects
Measured: 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
Measured: Screening visit
Assess fat-tissue mass and lean-tissue mass composition
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Diego Ruiz-Cárdenas, Universidad Católica San Antonio de Murcia
- Investigators
- Juan Diego JD Ruiz-Cárdenas, BSc, MSc, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434185
- Sponsor's protocol ID
- UCAM-BLD-1
- Status last verified
- Oct 2018
- First submitted
- 30 Apr 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruiz-Cardenas JD, Rodriguez-Juan JJ, Jakobi JM, Rios-Diaz J, Marin-Cascales E, Rubio-Arias JA. Bilateral deficit in explosive force related to sit-to-stand performance in older postmenopausal women. Arch Gerontol Geriatr. 2018 Jan;74:145-149. doi: 10.1016/j.archger.2017.10.023. Epub 2017 Oct 31.
PubMed 29102831
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bilateral Deficit Phenomenon, Functional and Dynamometric Assessment in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT02434185
- Acronym / sponsor ID
- UCAM-BLD-1
- Conditions
- Postmenopausal Syndrome, Muscle Weakness
- Keywords
- Musculoskeletal Physiological Phenomena, Postmenopause, Muscle Strength, Absorptiometry, Photon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women not experienced in strength training or resistance, without musculoskeletal, neurological diseases, and cardiovascular limiting-factor.
Key inclusion criteria (1 listed)
- Postmenopausal women
Key exclusion criteria (5 listed)
- Unexperienced in strength training or resistance training.
- Not musculoskeletal diseases.
- Not neurological diseases.
- Not cardiovascular limiting-diseases.
- Not fragility or pre-fragility phenotype.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the maximum force of lower limbs during bilateral and unilateral contraction
Time frame: Screening visit
Assess the force-time curve during climbing a step
Time frame: Screening visit
Assess the force-time curve during climbing rising from a chair
Time frame: Screening visit
Assess bone mineral-free lean tissue mass by dual energy X-ray absorptiometry
Time frame: Screening visit
Assess the fragility phenotype of the subjects
Time frame: 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
Assess fat-tissue mass and lean-tissue mass composition
Time frame: Screening visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 29102831Ruiz-Cardenas JD, Rodriguez-Juan JJ, Jakobi JM, Rios-Diaz J, Marin-Cascales E, Rubio-Arias JA. Bilateral deficit in explosive force related to sit-to-stand performance in older postmenopausal women. Arch Gerontol Geriatr. 2018 Jan;74:145-149. doi: 10.1016/j.archger.2017.10.023. Epub 2017 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Diego JD Ruiz-Cárdenas, BSc, MSc principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Syndrome and Muscle Weakness, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the maximum force of lower limbs during bilateral and unilateral contraction (time frame: Screening visit). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.