Back to resultsElectrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
Primary Purpose
Electric Stimulation Therapy, Frailty, Women
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
High-frequency electrical muscle stimulation training
Low-frequency electrical muscle stimulation training
Sponsored by
About this trial
This is an interventional treatment trial for Electric Stimulation Therapy
Eligibility Criteria
Inclusion Criteria:
- Post-menopausal women
Exclusion Criteria:
- Arrhythmias
- Diabetes
- Smokers
Sites / Locations
- Universidad Francisco de Vitoria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
High-frequency electrical muscle stimulation
Low-frequency electrical muscle stimulation
Control
Arm Description
Outcomes
Primary Outcome Measures
Stiffness
Quadriceps stiffness will be measured in Pascals by sonoelastography
Secondary Outcome Measures
Functional capacity
Functional capacity will be measured in repetitions by the 30 seconds Chair Stand Test
Full Information
NCT ID
NCT04276077
First Posted
February 17, 2020
Last Updated
May 9, 2023
Sponsor
Universidad Complutense de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT04276077
Brief Title
Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
Official Title
Effects of Different Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Electric Stimulation Therapy, Frailty, Women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High-frequency electrical muscle stimulation
Arm Type
Experimental
Arm Title
Low-frequency electrical muscle stimulation
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
High-frequency electrical muscle stimulation training
Intervention Description
High-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks
Intervention Type
Other
Intervention Name(s)
Low-frequency electrical muscle stimulation training
Intervention Description
Low-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks
Primary Outcome Measure Information:
Title
Stiffness
Description
Quadriceps stiffness will be measured in Pascals by sonoelastography
Time Frame
Change from Baseline stiffness at 8 weeks
Secondary Outcome Measure Information:
Title
Functional capacity
Description
Functional capacity will be measured in repetitions by the 30 seconds Chair Stand Test
Time Frame
Change from Baseline functional capacity at 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-menopausal women
Exclusion Criteria:
Arrhythmias
Diabetes
Smokers
Facility Information:
Facility Name
Universidad Francisco de Vitoria
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
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