Healthy PopulationCoFiKSaNCT03509818
Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population
A study testing plyometric exercise and Aerobic exercise in people with Healthy Population, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Exercise program in serum Klotho levels Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Population
- What is being tested?
- plyometric exercise and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2018to 26 Mar 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy people between 20 and 45 years old
Who cannot join
- acute and chronic disease, people who take medication and supplements, smoker.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Escuela de Doctorado e Invesitgacion, Universidad Europea
Madrid, Villaviciosa de Odon, 28670
About this study
Official title: Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation
Exercise program in serum Klotho levels
Read the detailed description
This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population
- Conditions
- Healthy Population
- Being tested
- plyometric exercise, Aerobic exercise
- Keywords
- Klotho, Exercise, Physical Fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plyometric exerciseOther
acute plyometric exercise
Aerobic exerciseOther
acute aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Plyometric | Experimental | Effects of plyometric acute exercise Receives: Other: plyometric exercise |
| Aerobic | Experimental | Effects of aerobic acute exercise Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum Klotho levels
Change from baseline to acute exercise session
Measured: Baseline and one hour
Secondary outcomes (6)
Change in Cardiorespiratory Fitness VO2max
For this Variable All people Will perform a exercise test on treadmill (Tecnhogym run race 1400HC; Gambettola, Italy), in this way we determinate the VO2max. Through the modifies Balke protocol. The gas Exchange data Will measured breath by breath using open circuit spirometry and specific face mask for Fitmate, Cosmed; Vmax 29C, Sensormedics machine.
Measured: Baseline
Change in Body Composition
The age in years; height in centimeters (tallimeter Ano Sayol SL, Barcelona, Spain); weight in kilograms (Inbody 720, Microcaya) and we can derive from this data the variable of Body Mass Index (BMI) calculated as weight (kg)/height (m2).
Measured: Baseline
Change in Body Composition, Body muscle mass Index
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)
Measured: Baseline
Change in Body Composition, % of Fat Mass
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)
Measured: Baseline
Change in Body Composition, Total Muscle Mass
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)
Measured: Baseline
Change in Body Composition, Visceral Fat Index.
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA). This value is really important to determine a cardiovascular risk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start21 Mar 2018
- Primary completion30 Oct 2018
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy PopulationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Description of the sample
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Perez, Universidad Europea de Madrid
- Investigators
- Valentin Fernandez Elias, Ph, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509818
- Sponsor's protocol ID
- Ref 47/764390.09/17
- Acronym
- CoFiKSa
- Status last verified
- Jul 2019
- First submitted
- 19 Mar 2018
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation
- ClinicalTrials.gov ID
- NCT03509818
- Acronym / sponsor ID
- CoFiKSa / Ref 47/764390.09/17
- Conditions
- Healthy Population
- Keywords
- Klotho, Exercise, Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 26 Apr 2018 (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.
Exercise program in serum Klotho levels
Detailed description
This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Description of the sample
| Arm | Type | Receives |
|---|---|---|
| Plyometric | Experimental | Other: plyometric exerciseEffects of plyometric acute exercise |
| Aerobic | Experimental | Other: Aerobic exerciseEffects of aerobic acute exercise |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy people between 20 and 45 years old
Key exclusion criteria (1 listed)
- acute and chronic disease, people who take medication and supplements, smoker.
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 |
|---|---|---|
| plyometric exerciseacute plyometric exercise | Other | Plyometric |
| Aerobic exerciseacute aerobic exercise | Other | Aerobic |
Primary outcome
Change in serum Klotho levels
Time frame: Baseline and one hour
Change from baseline to acute exercise session
6 secondary outcomes
Change in Cardiorespiratory Fitness VO2max
Time frame: Baseline
Change in Body Composition
Time frame: Baseline
Change in Body Composition, Body muscle mass Index
Time frame: Baseline
Change in Body Composition, % of Fat Mass
Time frame: Baseline
Change in Body Composition, Total Muscle Mass
Time frame: Baseline
Change in Body Composition, Visceral Fat Index.
Time frame: Baseline
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 23 Jul 2019.
- 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.
Valentin Fernandez Elias, Ph principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plyometric exercise and Aerobic exercise in people with Healthy Population, run by Universidad Europea 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 1 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 23 Jul 2019. 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?
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?
Change in serum Klotho levels (time frame: Baseline and one hour). 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 23 Jul 2019.