Clinical trial NCT02434185: The Bilateral Deficit Phenomenon, Functional and Dynamometric Assessment in Postmenopausal Women
Official title: The Bilateral Deficit Phenomenon, Functional and Dynamometric Assessment in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Syndrome
Muscle Weakness
Keywords: Musculoskeletal Physiological Phenomena
Postmenopause
Muscle Strength
Absorptiometry, Photon
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal women not experienced in strength training or resistance, without musculoskeletal, neurological diseases, and cardiovascular limiting-factor.

Brief 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). 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess the maximum force of lower limbs during bilateral and unilateral contraction
timeFrame: Screening visit
measure: Assess the force-time curve during climbing a step
timeFrame: Screening visit
measure: Assess the force-time curve during climbing rising from a chair
timeFrame: Screening visit
measure: Assess bone mineral-free lean tissue mass by dual energy X-ray absorptiometry
timeFrame: Screening visit
measure: Assess the fragility phenotype of the subjects
timeFrame: Screening visit
measure: Assess the rate of force developed in time intervals (0-50, 50-100, 100-150ms) of lower limbs during bilateral and unilateral contraction
timeFrame: Screening visit
measure: Assess fat-tissue mass and lean-tissue mass composition
timeFrame: Screening visit
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Juan Diego JD Ruiz-Cárdenas, BSc, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.