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
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).
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's enrollment of 74 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →This is the only study on the registry with Manuel Castillo Garzón as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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
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.
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.
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.
Body composition.
Measure by DXA.
Time frame: Baseline and through study completion, an average of 12 weeks.
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.
Hearth Rate Variability (HRV).
Measure by Polar RS800CX.
Time frame: Baseline and through study completion, an average of 12 weeks.
Biochemical profile.
General biochemical profile in blood samples
Time frame: Baseline and through study completion, an average of 12 weeks.
Physical activity.
The amount of physical activity will be measured by accelerometer.
Time frame: Baseline and through study completion, an average of 12 weeks.
Reaction time.
Measure by Vienna System.
Time frame: Baseline and through study completion, an average of 12 weeks.
Cognitive test.
Auditory memory tests
Time frame: Baseline and through study completion, an average of 12 weeks.
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..
Anthopometric measures.
Measure by stadiometer and scale.
Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
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..
Hormones profile
Hormones profile measure in blood samples.
Time frame: Baseline and post-Baseline and through study completion, an average of 12 weeks..
No study locations are listed for this record.
Plan to share: No
Ran from Jun 2016 to primary completion in Dec 2017, 18 months.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 18 months is close to that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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