NCT04276077

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 17, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

3.8 years

First QC Date

February 17, 2020

Last Update Submit

May 9, 2023

Conditions

Electric Stimulation TherapyFrailtyWomen

Outcome Measures

Primary Outcomes (1)

  • Stiffness

    Quadriceps stiffness will be measured in Pascals by sonoelastography

    Change from Baseline stiffness at 8 weeks

Secondary Outcomes (1)

  • Functional capacity

    Change from Baseline functional capacity at 8 weeks

Study Arms (3)

High-frequency electrical muscle stimulation

EXPERIMENTAL
Other: High-frequency electrical muscle stimulation training

Low-frequency electrical muscle stimulation

EXPERIMENTAL
Other: Low-frequency electrical muscle stimulation training

Control

NO INTERVENTION

Interventions

High-frequency electrical muscle stimulation trainingOTHER

High-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks

High-frequency electrical muscle stimulation
Low-frequency electrical muscle stimulation trainingOTHER

Low-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks

Low-frequency electrical muscle stimulation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Post-menopausal women

You may not qualify if:

  • Arrhythmias
  • Diabetes
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 19, 2020

Study Start

February 18, 2020

Primary Completion

December 15, 2023

Study Completion

December 30, 2023

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

ES(1)