- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03509818
Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population (CoFiKSa)
July 22, 2019 updated by: Margarita Perez, Universidad Europea de Madrid
Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation
Exercise program in serum Klotho levels
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study aims to analiyze the effects of acute exercise in serum Klotho levels attending physical fitness in healthy population
Study Type
Interventional
Enrollment (Actual)
85
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Villaviciosa De Odon
-
Madrid, Villaviciosa De Odon, Spain, 28670
- Escuela de Doctorado e Invesitgacion, Universidad Europea
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- healthy people between 20 and 45 years old
Exclusion Criteria:
- acute and chronic disease, people who take medication and supplements, smoker.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Plyometric
Effects of plyometric acute exercise
|
acute plyometric exercise
|
Experimental: Aerobic
Effects of aerobic acute exercise
|
acute aerobic exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum Klotho levels
Time Frame: Baseline and one hour
|
Change from baseline to acute exercise session
|
Baseline and one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cardiorespiratory Fitness VO2max
Time Frame: Baseline
|
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.
|
Baseline
|
Change in Body Composition
Time Frame: Baseline
|
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).
|
Baseline
|
Change in Body Composition, Body muscle mass Index
Time Frame: Baseline
|
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)
|
Baseline
|
Change in Body Composition, % of Fat Mass
Time Frame: Baseline
|
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)
|
Baseline
|
Change in Body Composition, Total Muscle Mass
Time Frame: Baseline
|
For determinate this variable of the body composition will be use a Dual Densitometry X-Ray (DXA) (Hologic QDR Discovery, Bedford, MA, USA)
|
Baseline
|
Change in Body Composition, Visceral Fat Index.
Time Frame: Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Valentin Fernandez Elias, Ph, Universidad Europea de Madrid
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2018
Primary Completion (Actual)
October 30, 2018
Study Completion (Actual)
March 26, 2019
Study Registration Dates
First Submitted
March 19, 2018
First Submitted That Met QC Criteria
April 16, 2018
First Posted (Actual)
April 26, 2018
Study Record Updates
Last Update Posted (Actual)
July 23, 2019
Last Update Submitted That Met QC Criteria
July 22, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Ref 47/764390.09/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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