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CompletedNCT03334357FIT-AGINGUpdated Oct 12, 2018

Physical Fitness as Klotho Protein Stimulator.

An interventional study of PAR and HIIT in Physical Activity and Aging, sponsored by Manuel Castillo Garzón. Completed. Open to participants aged 40 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-12.

Sponsored by Manuel Castillo Garzón · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Physical Activity
  • Aging

Keywords

  • Physical fitness
  • Klotho
  • Training
  • HIIT
  • WB-EMS
03

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • 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

Interventions

  • OtherPAR
  • OtherHIIT
  • OtherWB-EMS
05

What researchers measure

Primary outcomes

  1. α-Klotho protein

    Plasma Klotho concentrations will be measured by ELISA using a soluble α-Klotho ELISA assay kit.

    Time frame: Baseline and through study completion, an average of 12 weeks.

Secondary outcomes

  1. Physical fitness: cardiorespiratory fitness

    Cardiorespiratory fitness measure through a maximum treadmill test (VO2max.).

    Time frame: Baseline and through study completion, an average of 12 weeks.

  2. Physical fitness: muscular strength.

    Muscle strength measure through: Isokinetic strength, Handgrip strength and Core resistance stability.

    Time frame: Baseline and post-intervention.Baseline and through study completion, an average of 12 weeks.

  3. Body composition.

    Measure by DXA.

    Time frame: Baseline and through study completion, an average of 12 weeks.

  4. Resting energy expenditure.

    Evaluated by indirect calorimetry with gas analyzer breath by breath.

    Time frame: Baseline and through study completion, an average of 12 weeks.

  5. Hearth Rate Variability (HRV).

    Measure by Polar RS800CX.

    Time frame: Baseline and through study completion, an average of 12 weeks.

  6. Biochemical profile.

    General biochemical profile in blood samples

    Time frame: Baseline and through study completion, an average of 12 weeks.

  7. Physical activity.

    The amount of physical activity will be measured by accelerometer.

    Time frame: Baseline and through study completion, an average of 12 weeks.

  8. Reaction time.

    Measure by Vienna System.

    Time frame: Baseline and through study completion, an average of 12 weeks.

  9. Cognitive test.

    Auditory memory tests

    Time frame: Baseline and through study completion, an average of 12 weeks.

  10. Dietary assessment.

    Measure by 24h recall and Food Frecuency Questionnaire.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

  11. Anthopometric measures.

    Measure by stadiometer and scale.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

  12. Sleep quality.

    The quality of sleep will be measured by accelerometer.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

  13. Hormones profile

    Hormones profile measure in blood samples.

    Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Navarro-Lomas G, Dote-Montero M, Alcantara JMA, Plaza-Florido A, Castillo MJ, Amaro-Gahete FJ. Different exercise training modalities similarly improve heart rate variability in sedentary middle-aged adults: the FIT-AGEING randomized controlled trial. Eur J Appl Physiol. 2022 Aug;122(8):1863-1874. doi: 10.1007/s00421-022-04957-9. Epub 2022 May 10. PubMed 35538242 ↗
  • Dote-Montero M, De-la-O A, Jurado-Fasoli L, Ruiz JR, Castillo MJ, Amaro-Gahete FJ. The effects of three types of exercise training on steroid hormones in physically inactive middle-aged adults: a randomized controlled trial. Eur J Appl Physiol. 2021 Aug;121(8):2193-2206. doi: 10.1007/s00421-021-04692-7. Epub 2021 Apr 22. PubMed 33890158 ↗
  • Jurado-Fasoli L, Amaro-Gahete FJ, Merchan-Ramirez E, Labayen I, Ruiz JR. Relationships between diet and basal fat oxidation and maximal fat oxidation during exercise in sedentary adults. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1087-1101. doi: 10.1016/j.numecd.2020.11.021. Epub 2020 Dec 1. PubMed 33549436 ↗
  • De-la-O A, Jurado-Fasoli L, Castillo MJ, Gutierrez A, Amaro-Gahete FJ. 1,25-Dihydroxyvitamin D and S-Klotho Plasma Levels: The Relationship Between Two Renal Antiaging Biomarkers Mediated by Bone Mineral Density in Middle-Aged Sedentary Adults. Rejuvenation Res. 2021 Jun;24(3):227-233. doi: 10.1089/rej.2020.2384. Epub 2021 Mar 5. PubMed 33487127 ↗
  • Amaro-Gahete FJ, Sanchez-Delgado G, Ara I, R Ruiz J. Cardiorespiratory Fitness May Influence Metabolic Inflexibility During Exercise in Obese Persons. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5780-5790. doi: 10.1210/jc.2019-01225. PubMed 31322652 ↗
  • Jurado-Fasoli L, Amaro-Gahete FJ, De-la-O A, Castillo MJ. Impact of different exercise training modalities on energy and nutrient intake and food consumption in sedentary middle-aged adults: a randomised controlled trial. J Hum Nutr Diet. 2020 Feb;33(1):86-97. doi: 10.1111/jhn.12673. Epub 2019 Jul 3. PubMed 31270896 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03334357
Lead sponsor
Manuel Castillo Garzón
Responsible party
Manuel Castillo Garzón (University professor, Universidad de Granada) — Sponsor-investigator
First posted
Nov 7, 2017
Start date
Jun 1, 2016
Primary completion
Dec 23, 2017
Completion
Dec 23, 2017
Last update
Oct 12, 2018

Study contacts

Manuel J Castillo Garzón, Professor
principal investigator · Universidad de Granada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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