Physical Fitness as Klotho Protein Stimulator.

NCT03334357 | Completed

• 1 other identifier: FPU14/04172
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Physical Activity; Aging

Keywords

Physical fitness; Klotho; Training; HIIT; WB-EMS

Outcome Measures

Primary Outcomes (1)

• α-Klotho protein

  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 Outcomes (13)

• Physical fitness: cardiorespiratory fitness

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

• Physical fitness: muscular strength.

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

• Body composition.

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

• Resting energy expenditure.

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

• Hearth Rate Variability (HRV).

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

Study Arms (4)

Control

NO INTERVENTION

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

PAR group

EXPERIMENTAL

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

HIIT group.

EXPERIMENTAL

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

WB-EMS group.

EXPERIMENTAL

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

PAR OTHER

PAR group

HIIT OTHER

HIIT group.

WB-EMS OTHER

WB-EMS group.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Normal electrocardiogram
• 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

Sponsors & Collaborators

• Manuel Castillo Garzón: lead

Related Publications (6)

• 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.

  PMID: 35538242 DERIVED

• 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.

  PMID: 33890158 DERIVED

• 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.

  PMID: 33549436 DERIVED

• 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.

  PMID: 33487127 DERIVED

• 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.

  PMID: 31322652 DERIVED

• 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.

  PMID: 31270896 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Manuel J Castillo Garzón, Professor

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University professor

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: June 1, 2016
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share