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

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04276077
• Other study ID #: EMS_US
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: December 30, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-menopausal women

Exclusion Criteria:

• Arrhythmias

• Diabetes

• Smokers

Related Conditions & MeSH terms

• Electric Stimulation Therapy
• Frailty
• Women

Intervention

Other:
• High-frequency electrical muscle stimulation training
High-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks
• Low-frequency electrical muscle stimulation training
Low-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks

Locations

Country	Name	City	State
Spain	Universidad Francisco de Vitoria	Pozuelo De Alarcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stiffness	Quadriceps stiffness will be measured in Pascals by sonoelastography	Change from Baseline stiffness at 8 weeks
Secondary	Functional capacity	Functional capacity will be measured in repetitions by the 30 seconds Chair Stand Test	Change from Baseline functional capacity at 8 weeks