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

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ClinicalTrials.gov Identifier: NCT03334357
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Manuel Castillo Garzón, Universidad de Granada

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Physical Activity Aging Other: PAR Other: HIIT Other: WB-EMS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Physical Fitness as Klotho Protein Stimulator; Antiaging Effects of New Training Methods (FIT-AGING).
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : December 23, 2017
Actual Study Completion Date : December 23, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.).

  2. 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.

  3. Body composition. [ Time Frame: Baseline and through study completion, an average of 12 weeks. ]
    Measure by DXA.

  4. 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.

  5. Hearth Rate Variability (HRV). [ Time Frame: Baseline and through study completion, an average of 12 weeks. ]
    Measure by Polar RS800CX.

  6. Biochemical profile. [ Time Frame: Baseline and through study completion, an average of 12 weeks. ]
    General biochemical profile in blood samples

  7. Physical activity. [ Time Frame: Baseline and through study completion, an average of 12 weeks. ]
    The amount of physical activity will be measured by accelerometer.

  8. Reaction time. [ Time Frame: Baseline and through study completion, an average of 12 weeks. ]
    Measure by Vienna System.

  9. Cognitive test. [ Time Frame: Baseline and through study completion, an average of 12 weeks. ]
    Auditory memory tests

  10. 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.

  11. Anthopometric measures. [ Time Frame: Baseline and post-Baseline and through study completion, an average of 12 weeks.. ]
    Measure by stadiometer and scale.

  12. 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.

  13. Hormones profile [ Time Frame: Baseline and post-Baseline and through study completion, an average of 12 weeks.. ]
    Hormones profile measure in blood samples.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334357


Sponsors and Collaborators
Manuel Castillo Garzón
Investigators
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Principal Investigator: Manuel J Castillo Garzón, Professor Universidad de Granada

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Responsible Party: Manuel Castillo Garzón, University professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03334357     History of Changes
Other Study ID Numbers: FPU14/04172
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Manuel Castillo Garzón, Universidad de Granada:
Physical fitness
Klotho
Training
HIIT
WB-EMS