Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women

May 9, 2023 updated by: César Calvo Lobo, Universidad Complutense de Madrid

Effects of Different Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women

The aim of this study will be to determine the effects of different electrical muscle stimulation protocols on muscle stiffness and functional capacity in post-menopausal women. A randomized controlled clinical trial will be carried out. A total sample of 27 post-menopausal women will be recruited and divided into 3 groups which received high-frequency electrical muscle stimulation during 8 weeks, low-frequency electrical muscle stimulation during 8 weeks or no-intervention (control group). Outcome measurements will be stiffness assessed by sonoelastography and functional capacity assessed by the 30 seconds Chair-Stand Test before and after 8 weeks interventions.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

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
    • Madrid
      • Pozuelo De Alarcón, Madrid, Spain, 28223
        • Universidad Francisco de Vitoria

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Post-menopausal women

Exclusion Criteria:

  • Arrhythmias
  • Diabetes
  • Smokers

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: High-frequency electrical muscle stimulation
Other: High-frequency electrical muscle stimulation training
High-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks
Experimental: Low-frequency electrical muscle stimulation
Other: Low-frequency electrical muscle stimulation training
Low-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stiffness
Time Frame: Change from Baseline stiffness at 8 weeks
Quadriceps stiffness will be measured in Pascals by sonoelastography
Change from Baseline stiffness at 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity
Time Frame: Change from Baseline functional capacity at 8 weeks
Functional capacity will be measured in repetitions by the 30 seconds Chair Stand Test
Change from Baseline functional capacity at 8 weeks

Collaborators and Investigators

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

Sponsor

Universidad Complutense de Madrid

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 (Actual)

February 18, 2020

Primary Completion (Anticipated)

December 15, 2023

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 18, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMS_US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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