NCT02434185

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
Last Updated

October 15, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

April 30, 2015

Last Update Submit

October 10, 2018

Conditions

Keywords

Musculoskeletal Physiological PhenomenaPostmenopauseMuscle StrengthAbsorptiometry, Photon

Outcome Measures

Primary Outcomes (7)

  • Assess the maximum force of lower limbs during bilateral and unilateral contraction

    Screening visit

  • Assess the force-time curve during climbing a step

    Screening visit

  • Assess the force-time curve during climbing rising from a chair

    Screening visit

  • Assess bone mineral-free lean tissue mass by dual energy X-ray absorptiometry

    Screening visit

  • Assess the fragility phenotype of the subjects

    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

    Screening visit

  • Assess fat-tissue mass and lean-tissue mass composition

    Screening visit

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Postmenopausal women

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Juan Diego JD Ruiz-Cárdenas, BSc, MSc

    Universidad Católica San Antonio de Murcia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc, MSc

Study Record Dates

First Submitted

April 30, 2015

First Posted

May 5, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

October 15, 2018

Record last verified: 2018-10

Locations