Electric Stimulation TherapyNCT04276077
Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
A study testing High-frequency electrical muscle stimulation training and Low-frequency electrical muscle stimulation training in people with Electric Stimulation Therapy and Frailty, run by Universidad Complutense de Madrid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Electric Stimulation Therapy, Frailty, Women
- What is being tested?
- High-frequency electrical muscle stimulation training and Low-frequency electrical muscle stimulation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 18 Feb 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women
Who cannot join
- Arrhythmias
- Diabetes
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Electric Stimulation Therapy, Frailty, Women
- Being tested
- High-frequency electrical muscle stimulation training, Low-frequency electrical muscle stimulation training
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency electrical muscle stimulation trainingOther
High-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks
Low-frequency electrical muscle stimulation trainingOther
Low-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-frequency electrical muscle stimulation | Experimental | Not described Receives: Other: High-frequency electrical muscle stimulation training |
| Low-frequency electrical muscle stimulation | Experimental | Not described Receives: Other: Low-frequency electrical muscle stimulation training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stiffness
Quadriceps stiffness will be measured in Pascals by sonoelastography
Measured: Change from Baseline stiffness at 8 weeks
Secondary outcomes (1)
Functional capacity
Functional capacity will be measured in repetitions by the 30 seconds Chair Stand Test
Measured: Change from Baseline functional capacity at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start18 Feb 2020
- Primary completion15 Dec 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric Stimulation TherapyStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, César Calvo Lobo, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276077
- Sponsor's protocol ID
- EMS_US
- Status last verified
- May 2023
- First submitted
- 17 Feb 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Electrical Muscle Stimulation on Muscle Stiffness and Functional Capacity in Post-menopausal Women
- ClinicalTrials.gov ID
- NCT04276077
- Acronym / sponsor ID
- EMS_US
- Conditions
- Electric Stimulation Therapy, Frailty, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 19 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-menopausal women
Key exclusion criteria (3 listed)
- Arrhythmias
- Diabetes
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency electrical muscle stimulation trainingHigh-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks | Other | High-frequency electrical muscle stimulation |
| Low-frequency electrical muscle stimulation trainingLow-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks | Other | Low-frequency electrical muscle stimulation |
Primary outcome
Stiffness
Time frame: Change from Baseline stiffness at 8 weeks
Quadriceps stiffness will be measured in Pascals by sonoelastography
1 secondary outcome
Functional capacity
Time frame: Change from Baseline functional capacity at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency electrical muscle stimulation training and Low-frequency electrical muscle stimulation training in people with Electric Stimulation Therapy and Frailty, run by Universidad Complutense de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stiffness (time frame: Change from Baseline stiffness at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.