Electric ImpedanceNCT04269291
An Investigation Into an Objective Measure of Muscle Quality, Function and Ability
An observational study of Electric Impedance and Healthy Volunteers, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
The assessment of muscular function, quality and ability is of high importance in a diverse range of clinical disciplines from anaesthetics to physiotherapy. This study will look at the range of measurement techniques currently in use and development and considers their effectiveness and objectivity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electric Impedance, Healthy Volunteers
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2020to 1 Sep 2021
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- be volunteers
- be over the age of 18
- no pre-existing neuromuscular disease
- not have an implanted cardiac device
- be well at the time of measurement
- be able to give informed consent
Who cannot join
- Any existing neuromuscular disorder (eg multiple sclerosis, ALS, MND, CP)
- Any existing cardiac disease (including having a pacemaker or ICD)
- Active arthritis
- Be pregnant
- Any other implanted electrical device
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cardiff and Vale University Health Board.
Cardiff, CF14 4XW
About this study
The assessment of muscular function, quality and ability is of high importance in a diverse range of clinical disciplines from anaesthetics to physiotherapy. This study will look at the range of measurement techniques currently in use and development and considers their effectiveness and objectivity. It will also investigate whether an objective measurement technique can be found or developed that can be used both in the clinical environment and the community setting. This will focus on upper limb function and ability; ability is used here instead of strength since ability better describes functions needed for daily living rather than the maximum output a muscle is capable of.
Read the detailed description
A literature review (available on request) explores what can be measured, the problems of measurement and its objectivity. The aim is to investigate whether there is a method of measuring muscle quality, function and ability that can be used objectively in the clinical environment or the community with equal ease or whether such a method can be developed.
The literature review identified electrical impedance myography (EIM) as a potentially objective technique to measure muscle quality and ability. Two hypotheses are proposed to test the objectivity:
The EIM measurement of passive and active muscle is not significantly different.
EIM measurements in younger and older adult volunteers is significantly different.
There is only one study visit for this study, so all study activities will occur on the same day at the Posture and Mobility Centre, Treforest or the Artificial Limb and Appliance Centre, Rookwood Hospital.
Eligibility for the study will be checked against the inclusion and exclusion criteria, including the requests to not have done heavy exercise for an hour before the measurements and also to have emptied their bladder before attending for the visit.
Any concerns will be also be addressed appropriately
Following the eligibility check, the CI will ensure the participant has read the PIS and fully understand it before obtaining informed consent.
Participants will be assigned a number in order to anonymise their data and only the main investigator will have access to this database of participants.
The following data will then be collected by the CI and written in a Case Report Form (CRF):
- Gender
- Date of birth (to ascertain age)
- Height (to calculate BMI)
- Weight (to calculate BMI)
- Waist measurement (to calculate RFM index, considered an alternative indicator of health).
- Medical history to ensure no existing neuromuscular, active arthritis or cardiac conditions or active implanted devices
- Perceived level of fitness - using the NHS scale https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/ (to gauge muscle ability)
- A quantitative measurement method will be used in conjunction with a structured initial questionnaire relating to physical characteristics (e.g. height, weight, waist measurement, date of birth to indicate age and perceived level of fitness https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/).
The CI will then attach electrodes to the arm of the participant and they will be asked to relax for 10 minutes.
The measurement device is an ImpediMed IMP SFB7 (CE 0129 marked) and is portable. EIM passes an imperceptible AC current (less than 1 mA) through the muscle under investigation and the impedance of that muscle is then recorded through a range of frequencies or at chosen frequencies.
Measurements of EIM of the relaxed muscles will be recorded in the CRF followed by measurements of EIM in the contracted muscle.
Electrodes will be carefully removed from the participant and they are invited to relax for a further 5 minutes and have a drink of water.
The participant's involvement in the study will end after the measurements have been taken.
- Conditions
- Electric Impedance, Healthy Volunteers
- Keywords
- electrical impedance, skeletal muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of healthy volunteer measurement of Electrical Impedance Myography in arm muscles.
Primary Objective To measure EIM in sketetal arm muscle. Measurements to be made when the muscles are passive and when they are contracted.
EIM measurements are reactance and resistance which are both measured in Ohms.
At least 20 eligible and consented volunteers to be recruited and measured.
To be measured at the one healthy volunteer visit. No other visits are part of the study.
Measured: One visit per volunteer. Data to be accumulated over approximately 1 year
Secondary outcomes (2)
Age of participants
DOB recorded to classify healthy volunteers into age ranges.
This will be recorded at the one visit.
Measured: through study completion, an average of 1 year
Fitness health measure of participants
To calculate an indication of the health of the volunteers the following will be measured and recorded.
Height (m) Weight (kg) waist size (cm) Measured to calculate BMI index and RFM index (considered an alternative indicator of health).
All will be measured at the one visit. .
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start18 Jun 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electric ImpedanceStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Stephanie Wentworth, Cardiff and Vale University Health Board
- Investigators
- Stephanie Wentworth, Principal investigator, stephanie.wentworth@wales.nhs.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269291
- Sponsor's protocol ID
- 7703
- Status last verified
- Mar 2022
- First submitted
- 15 Jan 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into an Objective Measure of Muscle Quality, Function and Ability
- ClinicalTrials.gov ID
- NCT04269291
- Acronym / sponsor ID
- 7703
- Conditions
- Electric Impedance, Healthy Volunteers
- Keywords
- electrical impedance, skeletal muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 13 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 assessment of muscular function, quality and ability is of high importance in a diverse range of clinical disciplines from anaesthetics to physiotherapy. This study will look at the range of measurement techniques currently in use and development and considers their effectiveness and objectivity. It will also investigate whether an objective measurement technique can be found or developed that can be used both in the clinical environment and the community setting. This will focus on upper limb function and ability; ability is used here instead of strength since ability better describes functions needed for daily living rather than the maximum output a muscle is capable of.
Detailed description
A literature review (available on request) explores what can be measured, the problems of measurement and its objectivity. The aim is to investigate whether there is a method of measuring muscle quality, function and ability that can be used objectively in the clinical environment or the community with equal ease or whether such a method can be developed.
The literature review identified electrical impedance myography (EIM) as a potentially objective technique to measure muscle quality and ability. Two hypotheses are proposed to test the objectivity:
The EIM measurement of passive and active muscle is not significantly different.
EIM measurements in younger and older adult volunteers is significantly different.
There is only one study visit for this study, so all study activities will occur on the same day at the Posture and Mobility Centre, Treforest or the Artificial Limb and Appliance Centre, Rookwood Hospital.
Eligibility for the study will be checked against the inclusion and exclusion criteria, including the requests to not have done heavy exercise for an hour before the measurements and also to have emptied their bladder before attending for the visit.
Any concerns will be also be addressed appropriately
Following the eligibility check, the CI will ensure the participant has read the PIS and fully understand it before obtaining informed consent.
Participants will be assigned a number in order to anonymise their data and only the main investigator will have access to this database of participants.
The following data will then be collected by the CI and written in a Case Report Form (CRF):
- Gender
- Date of birth (to ascertain age)
- Height (to calculate BMI)
- Weight (to calculate BMI)
- Waist measurement (to calculate RFM index, considered an alternative indicator of health).
- Medical history to ensure no existing neuromuscular, active arthritis or cardiac conditions or active implanted devices
- Perceived level of fitness - using the NHS scale https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/ (to gauge muscle ability)
- A quantitative measurement method will be used in conjunction with a structured initial questionnaire relating to physical characteristics (e.g. height, weight, waist measurement, date of birth to indicate age and perceived level of fitness https://www.nhs.uk/live-well/healthy-weight/bmi-calculator/).
The CI will then attach electrodes to the arm of the participant and they will be asked to relax for 10 minutes.
The measurement device is an ImpediMed IMP SFB7 (CE 0129 marked) and is portable. EIM passes an imperceptible AC current (less than 1 mA) through the muscle under investigation and the impedance of that muscle is then recorded through a range of frequencies or at chosen frequencies.
Measurements of EIM of the relaxed muscles will be recorded in the CRF followed by measurements of EIM in the contracted muscle.
Electrodes will be carefully removed from the participant and they are invited to relax for a further 5 minutes and have a drink of water.
The participant's involvement in the study will end after the measurements have been taken.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (6 listed)
- be volunteers
- be over the age of 18
- no pre-existing neuromuscular disease
- not have an implanted cardiac device
- be well at the time of measurement
Key exclusion criteria (6 listed)
- Any existing neuromuscular disorder (eg multiple sclerosis, ALS, MND, CP)
- Any existing cardiac disease (including having a pacemaker or ICD)
- Active arthritis
- Be pregnant
- Any other implanted electrical device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observation of healthy volunteer measurement of Electrical Impedance Myography in arm muscles.
Time frame: One visit per volunteer. Data to be accumulated over approximately 1 year
Primary Objective To measure EIM in sketetal arm muscle. Measurements to be made when the muscles are passive and when they are contracted. EIM measurements are reactance and resistance which are both measured in Ohms. At least 20 eligible and consented volunteers to be recruited and measured. To be measured at the one healthy volunteer visit. No other visits are part of the study.
2 secondary outcomes
Age of participants
Time frame: through study completion, an average of 1 year
Fitness health measure of participants
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
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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.
Stephanie Wentworth principal investigator
stephanie.wentworth@wales.nhs.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electric Impedance and Healthy Volunteers, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 14 Mar 2022. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Observation of healthy volunteer measurement of Electrical Impedance Myography in arm muscles. (time frame: One visit per volunteer. Data to be accumulated over approximately 1 year). 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 14 Mar 2022.