Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population (CoFiKSa)

• ClinicalTrials.gov Identifier: NCT03509818
• Recruitment Status: Completed
• First Posted: April 26, 2018
• Last Update Posted: July 23, 2019
• Sponsor: Universidad Europea de Madrid
• Information provided by (Responsible Party): Margarita Perez, Universidad Europea de Madrid

Tracking Information

• First Submitted Date: March 19, 2018
• First Posted Date: April 26, 2018
• Last Update Posted Date: July 23, 2019
• Actual Study Start Date: March 21, 2018
• Actual Primary Completion Date: October 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 22, 2019)

Change in serum Klotho levels [ Time Frame: Baseline and one hour ]

Change from baseline to acute exercise session

Original Primary Outcome Measures (submitted: April 16, 2018)

Change in serum Klotho levels [ Time Frame: Baseline, one hour and twelve week ]

Change from baseline to acute intervention and chronic intervention

Current Secondary Outcome Measures (submitted: July 22, 2019)

• 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.
• 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).
• 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)
• 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)
• 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)
• 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.

Original Secondary Outcome Measures (submitted: April 16, 2018)

• Change in Cardiorespiratory Fitness VO2max [ Time Frame: Baseline and twelve week ]
  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.
• Change in Cardiorespiratory Fitness Vo2peak [ Time Frame: Baseline and twelve week ]
  Other Variable derived from the cardiorespiratory fitness test is The VO2peak it Will be recorded as the highest value obtains for any continuous 20-s period. Will be performed in Tecnhogym run race 1400HC; Gambettola, Italy treadmill with specific face mask for Fitmate, Cosmed, Vmax29C, Sensormedics machine.
• Change in Cardiorespiratory Fitness Ventilatory Threshold (VT) [ Time Frame: Baseline and twelve week ]
  In relation with VT Will be determine using the criteria of fan increase in both the ventilatory equivalent of oxygen (Ve/VO2) and end-tidal preassure of oxygen with no increase in the ventilatory equivalent of carbon dioxide with Tecnhogym run race 1400HC; Gambettola, Italy treadmil using the modifies Balke protocol with and specific face mask for Fitmate, Cosmed; Vmax 29C, Sensormedics machine.
• Change Muscle Strength [ Time Frame: Baseline and twelve week ]
  We will measure all of the sample with Dynamic upper and lower body muscle strength endurance using the bench press and leg press machines that were using for training (Thecnogym. Italy). The 8RM value Will be measure in kilograms ans is define as the maximum strength capacity to perform eight repetitions until momentary muscular exhaustion. The protocol consist in 5 warm-up sets at 50%, 70%, and 90% of the perceived 8RM by 1 min rest period. A 2 min rest period follow the last warm-up set after which a 8RM attempt Will make at 100% - 105% of perceived 8RM. This last period is the value for maximum muscle strength.
• Change in Body Composition [ Time Frame: Baseline and twelve week ]
  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).
• Change in Body Composition, Body Fat Index [ Time Frame: Baseline and twelve week ]
  For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. The datas of Total Body Fat Index shown in percentage and kilograms.
• Change in Body Composition, Fat Mass by body segment [ Time Frame: Baseline and twelve week ]
  For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. The datas of Fat Mass shown in kilograms. This is divided in upper limb and lower limb on both side (left and right) and Trunk Fat Mass.
• Change in Body Composition, Total Muscle Mass [ Time Frame: Baseline and twelve week ]
  For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. The datas of Total Muscle Mass shown in kilograms. This is divided in upper limb and lower limb on both side (left and right) and Trunk Muscle Mass.
• Change in Body Composition, Visceral Fat Index. [ Time Frame: Baseline and twelve week ]
  For determinate this variable of the body composition will be use a Bioelectrical impedance machine Inbody 720, Microcaya. This value is really important to determine a cardiovascular risk.
• Change in biochemical parameters, Glucose [ Time Frame: Baseline and twelve week ]
  Glucose is variable of screening for metabolic diseases, which is another value of healthy condition. these are measured on a journey of photometric analysis in test strips with a capillary blood brand machine Accutrend Plus. Values vary between 20 - 600mg/dl.
• Change in biochemical parameters, Triglycerides [ Time Frame: Baseline and twelve week ]
  Triglycerides is variable of screening for metabolic diseases, which is another value of healthy condition. these are measured on a journey of photometric analysis in test strips with a capillary blood brand machine Accutrend Plus. Values vary between 70 - 600 mg/dl.
• Change in biochemical parameters, Cholesterol [ Time Frame: Baseline and twelve week ]
  Cholesterol is variable of screening for metabolic diseases, which is another value of healthy condition. these are measured on a journey of photometric analysis in test strips with a capillary blood brand machine accutrend plus. Values vary between 150 - 300 mg/dl.
• Diagnostic of lifestyle and health status, PREDIMED Test [ Time Frame: Baseline ]
  PREDIMED consists in 14 items that give a results of 0 to 14. More than 9 determines a correct adherence to the mediterranean diet.
• Diagnostic of lifestyle and health status, GPAQ Test [ Time Frame: Baseline ]
  GPAQ, this questionnaire determines how much time (in minutes) a person remains active in a week. WHO determine 150 minutes per week at least of vigorous-moderate activity.
• Health status, PARQ & YOU [ Time Frame: Baseline ]
  we use the PARQ & YOU questionnaire which must answer NO to 9 questions asked. To determine a healthy condition, if is not (The subjet answer at least one of a 9 questions "Yes", you must go to a doctor before practice any type of exercises).
• Functional test battery, Sit & Reach [ Time Frame: Baseline and twelve week ]
  We will measure functional mobility with flexibility with Sit & Reach test with valid box, and the values are determined according to the age of the subject, wich can " 0 " or above " 0 ".
• Functional test battery, Counter Movement Jump (CMJ) [ Time Frame: Baseline and twelve week ]
  Is a vertical jump with Counter movement jump (CMJ) digital application, thet determine in centimeters the elevation of a subject jumping with the right feet up, wich indicates power train.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population
• Official Title: Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population: Response and Adaptation
• Brief Summary: 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Description of the sample

Masking: Single (Participant)
Primary Purpose: Other

• Condition: Healthy Population

Intervention

• Other: plyometric exercise
  acute plyometric exercise
• Other: Aerobic exercise
  acute aerobic exercise

Study Arms

• Experimental: Plyometric
  Effects of plyometric acute exercise
  Intervention: Other: plyometric exercise
• Experimental: Aerobic
  Effects of aerobic acute exercise
  Intervention: Other: Aerobic exercise

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 22, 2019): 85
• Original Estimated Enrollment (submitted: April 16, 2018): 54
• Actual Study Completion Date: March 26, 2019
• Actual Primary Completion Date: October 30, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• healthy people between 20 and 45 years old

Exclusion Criteria:

• acute and chronic disease, people who take medication and supplements, smoker.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT03509818
• Other Study ID Numbers: Ref 47/764390.09/17
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Margarita Perez, Universidad Europea de Madrid
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Europea de Madrid
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Valentin Fernandez Elias, Ph; Universidad Europea de Madrid

• PRS Account: Universidad Europea de Madrid
• Verification Date: July 2019