Physical Fitness as Klotho Protein Stimulator. (FIT-AGING)

October 11, 2018 updated by: Manuel Castillo Garzón

Physical Fitness as Klotho Protein Stimulator; Antiaging Effects of New Training Methods (FIT-AGING).

FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological consequences of activating Klotho gene (secondary outcomes).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aims: The plasma Klotho protein concentration (α-Klotho protein), which is considered a powerful biomarker of longevity, makes it an attractive target as an anti-aging therapy against functional decline, sarcopenic obesity, metabolic and cardiovascular diseases, osteoporosis, and neurodegenerative disorders. Physical exercise and physical fitness, could be α-Klotho protein activators through biochemical process. FIT-AGING will determine the effect of different exercise modalities on α-Klotho protein (primary outcome) in sedentary healthy adults. FIT-AGING also investigate the physiological consequences of activating Klotho gene (secondary outcomes).

Methods: FIT-AGING will recruit 60 sedentary, healthy, adults (50% women) aged 40-65 years. Eligible participants will be randomly assigned to a non-exercise group to the usual control group (n=15), physical activity recommendation from American College of Sport Medicine, World Health Organization and American Heart Association group (n=15), High Intensity Interval Training group (n=15)) and Whole-Body Electromyostimulation group (n=15). Laboratory measures completed at baseline and 12 weeks later, include α-Klotho protein concentration, physical fitness (cardiorespiratory fitness, muscular strength), body composition, resting metabolic rate, hearth rate variability (HRV), health blood biomarkers, free-living physical activity, sleep habits reaction time, cognitive variables and health-related questionnaires. The investigators will also obtain dietary habits data and cardiovascular disease risk factors.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

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

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 40-65 years
  • BMI:18.5-35 kg/m2
  • Not engaged in regular physical activity >20min on >3days/week
  • Not participating in a weight loss programme
  • Stable weight over the last 5 months (body weight changes>5kg)
  • Participant must be capable and willing to provide consent, understand exclusion criteria and accept the randomized group assignment
  • Normal electrocardiogram

Exclusion Criteria:

  • History of cardiovascular disease
  • Diabetes
  • Pregnancy or planning to get pregnant during study period
  • Beta blockers or benzodiapezins use
  • Taking medication for thyroid
  • Other significant conditions that are life-threatening or that can interfere with or be aggravated by exercise
  • Unwillingness to either complete the study requirements or to be randomized into control or training group
  • A first-degree relative with history of cancer

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Non-Exercise group. We will provide general advices to control group participants thought an information meeting performed by a graduate in Sport Sciences. It will recommended to follow the physical activity recommendations for adults provided by World Health Organization
Experimental: PAR group

The volume in PAR is based on the minimum physical activity recommended (150min/week at moderate intensity).

Intensity selected for PAR aerobic training is 60-65% HRres. Strength intensity selected was 40-50% of 1 RM.

Frequency. PAR group will train 3 days/week, the minimum frequency recommended. Exercises programmed for the aerobic exercise are treadmill, cycle-ergometer and elliptical ergometer in aerobic training part and weight bearing and guided pneumatic machines (involved major upper and lower body muscle group) in resistance training.

Training load variation. We propose a gradual progression to control the exercise dose Training periodization divided in two phases of 5 weeks each one, starting with a familiarization phase (2 weeks).

Training sessions. Sessions start with a dynamic standardized warm up, which include several muscle activation exercises. Aerobic sessions include compensatory exercises. Training session will be ended with a cooling-down protocol
Other: PAR
Experimental: HIIT group.

The volume in HIIT 40-65 min/week at high intensity. Intensity. Two different protocols: HIIT with long intervals (Type A session), which intensity will be >95% VO2max and HIIT with short intervals (Type B session), >120% VO2max.

Training frequency two times/week. Type of exercise. Type A session are walking in treadmill with personalized slopes. Eight weight-bearing exercises in circuit form, type B session.

Training load variation. Gradual progression to control the exercise dose. Training periodization divided in: familiarization phase, phase I, phase II. Training sessions. Type A: 5 minutes in treadmill at 60% VO2max. After warm-up, participants complete sets corresponding to each training session following the corresponding characteristics. Type B: eight weight-bearing exercises (in circuit form) two times/set with an active rest (walking at 60%VO2max) as many times at as defined. Training session will be ended with a cooling-down protocol
Other: HIIT
Experimental: WB-EMS group.

WB-EMS training program will be the same than HIIT intervention related to volume, intensity, frequency, type of exercise, training load variation, training periodization and training session. However, electrical impulse will be included in order to assess if WB-EMS training will produce an added effect compared to HIIT.

Electrical parameters:

We will apply a frequency of 15-33 Hz in type A session. And, we will apply a frequency of 35-75 Hz in type B session.

Intensity will be 80-100 mA. Impulse Width adjusted in relation to body segment: thigh zone (400μsec), glute zone (350μsec), abdominal zone (300μsec), dorsal zone (250μsec), cervical (200μsec), chest zone (200μsec) and arm zone (200μsec).

Duty cycle. We have programmed a duty cycle of 50-67% in type B session, but duty cycle in type A session will be 99%.

RPE impulse: the impulse intensity was individually adapted to generate similar values of rate of perceived exertion (RPE) in Borg CR-10 Scale "5" of "9"
Other: WB-EMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
α-Klotho protein
Time Frame: Baseline and through study completion, an average of 12 weeks.
Plasma Klotho concentrations will be measured by ELISA using a soluble α-Klotho ELISA assay kit.
Baseline and through study completion, an average of 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical fitness: cardiorespiratory fitness
Time Frame: Baseline and through study completion, an average of 12 weeks.
Cardiorespiratory fitness measure through a maximum treadmill test (VO2max.).
Baseline and through study completion, an average of 12 weeks.
Physical fitness: muscular strength.
Time Frame: Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.
Muscle strength measure through: Isokinetic strength, Handgrip strength and Core resistance stability.
Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.
Body composition.
Time Frame: Baseline and through study completion, an average of 12 weeks.
Measure by DXA.
Baseline and through study completion, an average of 12 weeks.
Resting energy expenditure.
Time Frame: Baseline and through study completion, an average of 12 weeks.
Evaluated by indirect calorimetry with gas analyzer breath by breath.
Baseline and through study completion, an average of 12 weeks.
Hearth Rate Variability (HRV).
Time Frame: Baseline and through study completion, an average of 12 weeks.
Measure by Polar RS800CX.
Baseline and through study completion, an average of 12 weeks.
Biochemical profile.
Time Frame: Baseline and through study completion, an average of 12 weeks.
General biochemical profile in blood samples
Baseline and through study completion, an average of 12 weeks.
Physical activity.
Time Frame: Baseline and through study completion, an average of 12 weeks.
The amount of physical activity will be measured by accelerometer.
Baseline and through study completion, an average of 12 weeks.
Reaction time.
Time Frame: Baseline and through study completion, an average of 12 weeks.
Measure by Vienna System.
Baseline and through study completion, an average of 12 weeks.
Cognitive test.
Time Frame: Baseline and through study completion, an average of 12 weeks.
Auditory memory tests
Baseline and through study completion, an average of 12 weeks.
Dietary assessment.
Time Frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Measure by 24h recall and Food Frecuency Questionnaire.
Baseline and post-Baseline and through study completion, an average of 12 weeks..
Anthopometric measures.
Time Frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Measure by stadiometer and scale.
Baseline and post-Baseline and through study completion, an average of 12 weeks..
Sleep quality.
Time Frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
The quality of sleep will be measured by accelerometer.
Baseline and post-Baseline and through study completion, an average of 12 weeks..
Hormones profile
Time Frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
Hormones profile measure in blood samples.
Baseline and post-Baseline and through study completion, an average of 12 weeks..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuel Castillo Garzón

Investigators

  • Principal Investigator: Manuel J Castillo Garzón, Professor, Universidad de Granada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2016

Primary Completion (Actual)

December 23, 2017

Study Completion (Actual)

December 23, 2017

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FPU14/04172

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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