Phase AngleNCT05583500
Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise
A study testing Experimental: Single group: excentric exercise protocol in people with Phase Angle, run by Universidad Francisco de Vitoria at 1 site in Spain.
Trial summary
The purpose of this study will be to assess the effectiveness of bioimpedance device (BIA) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Phase Angle
- What is being tested?
- Experimental: Single group: excentric exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 19 Sep 2022to 10 Jan 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjets
- Sedentary subjects
Who cannot join
- Trained subjects
- Subjects with musculoskeletal pathology
- Previous Surgeries in the last 6 months
- Subjects under pharmacological treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universidad Francisco de Vitoria
Pozuelo de Alarcón, Madrid, 28223
About this study
The purpose of this study will be to assess the effectiveness of bioimpedance device (BIA) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods.
A sample of 28 sedentary subjects will be recruited, all participants will perform an eccentric exercise protocol.
Read more
Measurements will be done before performing the exercise protocol, immediately after finishing the protocol, 3h after the end of the exercise protocol, 24h after the end of the exercise protocol and 48h after the end of the exercise protocol.
The variables analyzed in all subjects will be phase angle, creatinkinase, jumping strength, VAS scale, white blood count cell, quadriceps muscle thickness, Borg scale and anxiety and depression questionnaires.
- Conditions
- Phase Angle
- Being tested
- Experimental: Single group: excentric exercise protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Single group: excentric exercise protocolOther
Excentric exercise protocol will be performed for all subjets, consisted of 10 sets of 20 repetitions of squats, jumping from a height of 50 cm
| Study group | Role | What they receive |
|---|---|---|
| Single group: excentric exercise protocol | Experimental | Excentric exercise protocol will be performed for all subjets, consisted of 10 sets of 20 repetitions of squats, jumping from a height of 50 cm Receives: Other: Experimental: Single group: excentric exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase angle
The phase angle, which is measured via bioelectrical impedance analysis (BIA), InBody 770 ,is a clinically important bioimpedance parameter used for nutritional assessment and evaluating the risk of various diseases. The phase angle was calculated automatically by the BIA device from these two components according to the following formula: phase angle (°) = (reactance/resistance) × (180°/π).
Measured: change from baseline to 72 hours
Secondary outcomes (5)
Pain: VAS
Visual Analogic Scale. Pain will be measured with a visual analog scale from 0 to 10. 0 points is no pain.
Measured: change from baseline to 72 hours
Quadriceps thickness
Quadriceps muscle thickness will be measures in mm. by an ultrasound device
Measured: change from baseline to 72 hours
Creatinkinase (CK concentration)
CK concentration will be measure in mg/dl with a portal analyzer (SpotchemTM EZ SP-4430), using test strips.
Measured: change from baseline to 72 hours
cellular inflammatory markers
Cellular inflammatory markers will be measured with hematology analyzer (Sysmex KX-21N Automed) in 10^9/L and % White blood count, lymphocytes, neutrophils, monocytes, eosinophils, basophils will be analyzed
Measured: change from baseline to 72 hours
Leg power
Leg power will be assessed using vertical jump test, with Chronojump platform (CHRONOJUMP Boscosystem)
Measured: change from baseline to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start19 Sep 2022
- Primary completion19 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase AngleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Buffet García, Principal investigator, Universidad Francisco de Vitoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583500
- Sponsor's protocol ID
- UFV-JB22
- Status last verified
- Sep 2022
- First submitted
- 29 Sep 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Angle as a Marker of Muscle Damage, Muscle Fatigue and Inflammation, After Eccentric Exercise
- ClinicalTrials.gov ID
- NCT05583500
- Acronym / sponsor ID
- UFV-JB22
- Conditions
- Phase Angle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 19 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 17 Oct 2022 (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 purpose of this study will be to assess the effectiveness of bioimpedance device (BIA) as a safe, rapid, and non-invasive method of analyzing muscle damage induced by high intensity induced eccentric exercise as an alternative measurement tool against traditional assessment methods.
A sample of 28 sedentary subjects will be recruited, all participants will perform an eccentric exercise protocol.
Measurements will be done before performing the exercise protocol, immediately after finishing the protocol, 3h after the end of the exercise protocol, 24h after the end of the exercise protocol and 48h after the end of the exercise protocol.
The variables analyzed in all subjects will be phase angle, creatinkinase, jumping strength, VAS scale, white blood count cell, quadriceps muscle thickness, Borg scale and anxiety and depression questionnaires.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group: excentric exercise protocol | Experimental | Other: Experimental: Single group: excentric exercise protocolExcentric exercise protocol will be performed for all subjets, consisted of 10 sets of 20 repetitions of squats, jumping from a height of 50 cm |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy subjets
- Sedentary subjects
Key exclusion criteria (4 listed)
- Trained subjects
- Subjects with musculoskeletal pathology
- Previous Surgeries in the last 6 months
- Subjects under pharmacological treatment
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 |
|---|---|---|
| Experimental: Single group: excentric exercise protocolExcentric exercise protocol will be performed for all subjets, consisted of 10 sets of 20 repetitions of squats, jumping from a height of 50 cm | Other | Single group: excentric exercise protocol |
Primary outcome
Phase angle
Time frame: change from baseline to 72 hours
The phase angle, which is measured via bioelectrical impedance analysis (BIA), InBody 770 ,is a clinically important bioimpedance parameter used for nutritional assessment and evaluating the risk of various diseases. The phase angle was calculated automatically by the BIA device from these two components according to the following formula: phase angle (°) = (reactance/resistance) × (180°/π).
5 secondary outcomes
Pain: VAS
Time frame: change from baseline to 72 hours
Quadriceps thickness
Time frame: change from baseline to 72 hours
Creatinkinase (CK concentration)
Time frame: change from baseline to 72 hours
cellular inflammatory markers
Time frame: change from baseline to 72 hours
Leg power
Time frame: change from baseline to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Jorge Buffet García principal investigator
Universidad Francisco de Vitoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Single group: excentric exercise protocol in people with Phase Angle, run by Universidad Francisco de Vitoria 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 2 inclusion and 4 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 17 Oct 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 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?
Contact Jorge Buffet García (+34619903972, j.buffet.prof@ufv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase angle (time frame: change from baseline to 72 hours). 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 17 Oct 2022.