- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04118478
Effect of a Multi-component Training Program With Progressive Phases on the Elderly
Effects of Multicomponent Exercise Program With Progressive Phases on Functional Capacity, Fitness, Quality of Life, Dual-Task and Physiological Variables in Older Adults: Randomized Controlled Trial Protocol
The increase in life expectancy worldwide, added to the decrease in birth rates, has resulted in an increase in the aging population. In the case of Chile, 11.4% of its inhabitants are older adults and specifically, in the Til-Til commune, 14.65% of the total population is over 60 years of age, directly affecting the neuromuscular system and mainly cardiorespiratory. Therefore, the older person lives longer, but with a lower quality of life. Physical exercise appears as a non-pharmacological alternative to improve the quality of life, physical and cognitive functions. The "multi-component training" consists of a program that combines strength, resistance, balance and gait training, and is the one that presents the greatest improvements in the functional capacity of the elderly person.
The objective of the present investigation is to relate the effects of a multi-component training schedule by phases on the quality of life, functional capacity and physiological parameters in a group of people over 60 to 80 years of age in the commune of Til-Til.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Murcia, Spain, 30109
- Universidad Católica de Murcia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Multi-component phased training program
The intervention of the program consists of conducting a multi-component training in a neighborhood unit. The intervention will consist of the realization of a multi-component program in a training center adapted for the elderly. The duration of the program will be 27 weeks with a frequency of two weekly sessions and an intervention duration of 45 to 60 minutes |
The experimental group will develop a program that consists of three progressive phases with the predominance of one physical quality over the others.
The first phase will have as its main objective to develop strength, through exercises with overload and in turn, it will be subdivided into 3 blocks of 3 weeks each: Neuromuscular adaptation, muscular power, muscular resistance.
The second phase will have as its main objective to develop cardiorespiratory capacity through intermittent gait training and, in turn, will be subdivided into 3 blocks of 3 weeks each: Static gait, dynamic gait and dynamic gait with changes of direction.
The last phase will have as its main objective to develop balance and flexibility, by strengthening the stabilizing muscles and range of motion.
In turn, this phase will be subdivided into 3 blocks of 3 weeks each: Balance / static flexibility, balance / dynamic flexibility and balance / flexibility with a double task.
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NO_INTERVENTION: CONTROL
Older people assigned to the GC do not do any training programming.
Only attend the measurement dates.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the quality of life
Time Frame: Change from Baseline quality life at 2, 4 and at 6 month
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The quality of life will be assessed through the SF-36 health questionnaire, which represents a generic scale that provides a profile of the state of health and is applicable to both patients and the general population.
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Change from Baseline quality life at 2, 4 and at 6 month
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Heart rate variability
Time Frame: Change from Baseline Heart rate variability at 2, 4 and at 6 month
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The heart rate variability (CRV) corresponds to an indicator of the modulation exerted by the autonomic nervous system, which will be analyzed in the frequency and time domains and represents an adequate analysis of the variation from beat to beat, from a point of temporal view, expressing differences in the consecutive RR intervals of the QRS complexes of an electrocardiogram.
The VRC will be registered using the HRV Expert Cardiomood® smartphone application, which is capable of recording the RR intervals for analysis of the VRC indexes with high level of reliability (R = 0.97) and the H7® POLAR model heart rate monitor capable of recording these intervals as reliably (r = 0.99) as an electrocardiogram (ECG) test
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Change from Baseline Heart rate variability at 2, 4 and at 6 month
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Spirometry, forced expiratory volume in one second (FEV1)
Time Frame: Change from Baseline Spirometry FEV1 at 2, 4 and at 6 month
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Spirometry is a fundamental test in functional respiratory evaluation, which is frequently used in clinical practice and in population studies, due to its good reproducibility, ease of measurement and its degree of correlation with the stage of the disease, functional condition , morbidity and mortality. Forced Espiratory Volume1, (FEV1): Amount of air that mobilizes in the first second of an expiration forced. It is a flow, not a volume (milliliters / 1 sg), so which can be expressed as ml / s or as a percentage in front of his theoretical figures. Its normal value is greater than 80% The device used to measure this pulmonary parameter will be the Manual Spirometer CMS-SP10® of small volume and easy application. |
Change from Baseline Spirometry FEV1 at 2, 4 and at 6 month
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Spirometry, peak expiratory flow (PEF)
Time Frame: Change from Baseline Spirometry PEF at 2, 4 and at 6 month
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Spirometry is a fundamental test in functional respiratory evaluation, which is frequently used in clinical practice and in population studies, due to its good reproducibility, ease of measurement and its degree of correlation with the stage of the disease, functional condition , morbidity and mortality. Peak Espiratory Flow, (PEF): Maximum amount of air that can be exhaled by second in a forced expiration. It is the maximum peak of flow which is obtained (flow - volume curve), and is produced before having expelled 15% of the FVC. It is a marker especially useful in the diagnosis of asthma and in crises asthmatics, where predictive target value of gravity. It is measured in liters / sec, or as a percentage of the reference value. The device used to measure this pulmonary parameter will be the Manual Spirometer CMS-SP10® of small volume and easy application. |
Change from Baseline Spirometry PEF at 2, 4 and at 6 month
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Resting Heart rate
Time Frame: Change from Baseline Resting Heart rate at 2, 4 and at 6 month
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The heart rate (HR) is determined by the balance between the sympathetic and parasympathetic systems, which responds to the body's needs at all times.
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Change from Baseline Resting Heart rate at 2, 4 and at 6 month
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Resting blood pressure
Time Frame: Change from resting blood pressure at 2, 4 and at 6 month
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Blood pressure (BP) shows a progressive increase with age and it is observed that systolic blood pressure shows a continuous increase, while diastolic pressure begins to decline after the age of 50 in both sexes.
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Change from resting blood pressure at 2, 4 and at 6 month
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Short Physical Performance Battery (SPPB)
Time Frame: Change from Baseline SPPB at 2, 4 and at 6 month
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It is a battery widely used in research and covers a wide spectrum of functional levels.
It has proven its validity, reproducibility and sensitivity to change in different American and European populations with good results.
It is composed of three subtests: one of balance (balance with feet together, in semi-tandem and in tandem), another of leg thrust (getting up and sitting from a chair without armrests five times as quickly as possible) and a third, consisting of measuring the normal speed of walking along 4 and 6 meters.
The score ranges between 0 and 12 points, and scores between 4 and 9 are suggestive of fragility.
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Change from Baseline SPPB at 2, 4 and at 6 month
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Walking speed in 4 and 6 meters
Time Frame: Change from Baseline Walking speed in 4 and 6 meters at 2, 4 and at 6 month
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Evaluation method that has taken great relevance recently and is even advocated as the simplest and most valid way of evaluation in the elderly.
For its measurement, the time it takes for the older person to travel a certain distance is calculated (in the case of the present investigation it will be in 4 and 6 meters), and then it is passed to meters / second.
It is usually evaluated at a normal pace, although it can also be done at a fast pace.
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Change from Baseline Walking speed in 4 and 6 meters at 2, 4 and at 6 month
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Time Up and Go
Time Frame: Change from Baseline Time Up and Go at 2, 4 and at 6 month
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It is a tool to assess the mobility and function of the lower limb, which proves to be useful, practical, fast and simple, without requiring a special team or specific training by the evaluator.
Measure the time in seconds the subject takes to get up from a chair, walk 3 meters, turn, walk back to normal pace and sit down.
This test has a good correlation with the measures of balance, walking speed, functionality and cognition, especially with the executive functions, memory and processing speed.
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Change from Baseline Time Up and Go at 2, 4 and at 6 month
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Dynamometry
Time Frame: Change from Baseline Dynamometry at 2, 4 and at 6 month
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The use of the dynamometer allows to determine the maximum isometric force in different muscle groups.
Among them, the measurement of the pressing force of the dominant hand is especially important, given that it is a simple and non-invasive marker of muscular strength of the upper extremities.
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Change from Baseline Dynamometry at 2, 4 and at 6 month
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Walking While Talking (WWT)
Time Frame: Change from Baseline Walking While Talking at 2, 4 and at 6 month
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This test will evaluate the speed of travel under the condition of counting backwards (from number 20 backwards) while walking at a distance of 6 meters, which has been proposed as a better instrument for measuring the speed of travel, because to which adds conditions of stress, difficulty or distraction, which presents a greater sensitivity to detect early mobility problems or preclinical disability
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Change from Baseline Walking While Talking at 2, 4 and at 6 month
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Two minutes "Step test"
Time Frame: Change from Baseline Two minutes "Step test" at 2, 4 and at 6 month
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The test consists of performing the greatest number of steps marching in place for two minutes, each knee reaching an intermediate point between the patella and the anterior superior iliac spine.
Although both knees must reach the correct height, only the number of times the right knee reaches the determined height is counted
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Change from Baseline Two minutes "Step test" at 2, 4 and at 6 month
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Sit and reach test
Time Frame: Change from Baseline Sit and reach test at 2, 4 and at 6 month
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This test will measure the flexibility of the lower body, mainly the biceps femoris and the lower back.
It is an adapted version of the Wells test that measures the flexibility of both legs simultaneously, to an alternative consisting of evaluating only one lower limb sitting in a chair.
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Change from Baseline Sit and reach test at 2, 4 and at 6 month
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Back scratch test
Time Frame: Change from Baseline Back scratch test at 2, 4 and at 6 month
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This test will assess the flexibility of the upper body, specifically the mobility of the shoulder joint and validly shows the expected reduction in shoulder flexibility in subjects aged 60 to 80 years.
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Change from Baseline Back scratch test at 2, 4 and at 6 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation for the exercise
Time Frame: Change from Baseline Motivation for the exercise at 6 month
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The motivation for the physical exercise will be evaluated through the Questionnaire of the Regulation of the Conduct in the Exercise (BREQ-3), which is headed by the sentence "I do physical exercise ..." in 23 items: Four for intrinsic regulation , four for integrated regulation ("because it agrees with my way of life", "because I consider that physical exercise is part of me", "because I see physical exercise as a fundamental part of who I am", "because I consider that the physical exercise is in accordance with my values "), three for identified regulation, four for introjected regulation, four for external regulation and four for demotivation.
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Change from Baseline Motivation for the exercise at 6 month
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"Physical Activity Vital Sign" (PAVS)
Time Frame: Change from Baseline "Physical Activity Vital Sign" at 6 month
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The level of physical activity will be recorded through two questionnaire: "Vital Sign of Physical Activity" (SVAF).
The SVAF was developed as a simple questionnaire for use in a clinical setting with the objective of assessing moderate to vigorous physical activity (AFMV) of the last week and of a typical (usual) week.
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Change from Baseline "Physical Activity Vital Sign" at 6 month
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"Stanford Short Activity Survey"
Time Frame: Change from Baseline "Stanford Short Activity Survey" at 6 month
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"Stanford Short Activity Survey" was developed to classify the levels of physical activity at work and during leisure time.
The study used five brief descriptions of physical activity profiles, which are named inactive at high levels of commitment to exercise.
Respondents select one profile for work and another for free time.
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Change from Baseline "Stanford Short Activity Survey" at 6 month
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Abdominal circumference
Time Frame: Change from Baseline Abdominal circumference at 2, 4 and at 6 month
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The measurement will be performed with a SECA S201® measuring tape with an accuracy of 0.1 cm.
The tape will be located in the midpoint between the internal rib edge of the last rib intercepted with the anterior axillary line and the iliac crest and it will be verified that the person is not inspired or forced expiration, registering the waist circumference obtained in centimeters .
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Change from Baseline Abdominal circumference at 2, 4 and at 6 month
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Electrical impedance
Time Frame: Change from Baseline Electrical impedance at 2, 4 and at 6 month
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It is a safe, fast, simple, non-invasive procedure and with a good correlation with more complex techniques.
Studies have shown that electrical bioimpedance is a safe, reproducible and reliable method to assess body composition.
The instrument to be used for research is the OMRON HBF-514® model.
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Change from Baseline Electrical impedance at 2, 4 and at 6 month
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Collaborators and Investigators
Investigators
- Principal Investigator: Emilio Jofré-Saldía, MSc, UCAM
- Study Director: Gemma García, Phd, UCAM
- Principal Investigator: Alvaro Villalobos, Msc, UCH
Publications and helpful links
General Publications
- Ball TJ, Joy EA, Gren LH, Shaw JM. Concurrent Validity of a Self-Reported Physical Activity "Vital Sign" Questionnaire With Adult Primary Care Patients. Prev Chronic Dis. 2016 Feb 4;13:E16. doi: 10.5888/pcd13.150228. Erratum In: Prev Chronic Dis. 2016;13:E30.
- Bouaziz W, Vogel T, Schmitt E, Kaltenbach G, Geny B, Lang PO. Health benefits of aerobic training programs in adults aged 70 and over: a systematic review. Arch Gerontol Geriatr. 2017 Mar-Apr;69:110-127. doi: 10.1016/j.archger.2016.10.012. Epub 2016 Oct 31.
- Cabrero-Garcia J, Munoz-Mendoza CL, Cabanero-Martinez MJ, Gonzalez-Llopis L, Ramos-Pichardo JD, Reig-Ferrer A. [Short physical performance battery reference values for patients 70 years-old and over in primary health care]. Aten Primaria. 2012 Sep;44(9):540-8. doi: 10.1016/j.aprim.2012.02.007. Epub 2012 May 16. Spanish.
- Cadore EL, Menger E, Teodoro JL, da Silva LXN, Boeno FP, Umpierre D, Botton CE, Ferrari R, Cunha GDS, Izquierdo M, Pinto RS. Functional and physiological adaptations following concurrent training using sets with and without concentric failure in elderly men: A randomized clinical trial. Exp Gerontol. 2018 Sep;110:182-190. doi: 10.1016/j.exger.2018.06.011. Epub 2018 Jun 13.
- Chan WC, Yeung JW, Wong CS, Lam LC, Chung KF, Luk JK, Lee JS, Law AC. Efficacy of physical exercise in preventing falls in older adults with cognitive impairment: a systematic review and meta-analysis. J Am Med Dir Assoc. 2015 Feb;16(2):149-54. doi: 10.1016/j.jamda.2014.08.007. Epub 2014 Oct 7.
- Coelho-Junior HJ, de Oliveira Goncalvez I, Sampaio RAC, Sewo Sampaio PY, Cadore EL, Izquierdo M, Marzetti E, Uchida MC. Periodized and non-periodized resistance training programs on body composition and physical function of older women. Exp Gerontol. 2019 Jul 1;121:10-18. doi: 10.1016/j.exger.2019.03.001. Epub 2019 Mar 9.
- Fragala MS, Cadore EL, Dorgo S, Izquierdo M, Kraemer WJ, Peterson MD, Ryan ED. Resistance Training for Older Adults: Position Statement From the National Strength and Conditioning Association. J Strength Cond Res. 2019 Aug;33(8):2019-2052. doi: 10.1519/JSC.0000000000003230.
- Gomez-Morales A, Miranda JMA, Pergola-Marconato AM, Mansano-Schlosser TC, Mendes FRP, Torres GV. [The influence of activities on the quality of life of the elderly: a systematic review]. Cien Saude Colet. 2019 Jan;24(1):189-202. doi: 10.1590/1413-81232018241.05452017. Spanish.
- Guizelini PC, de Aguiar RA, Denadai BS, Caputo F, Greco CC. Effect of resistance training on muscle strength and rate of force development in healthy older adults: A systematic review and meta-analysis. Exp Gerontol. 2018 Feb;102:51-58. doi: 10.1016/j.exger.2017.11.020. Epub 2017 Nov 28.
- Izquierdo M. [Multicomponent physical exercise program: Vivifrail]. Nutr Hosp. 2019 Jul 1;36(Spec No2):50-56. doi: 10.20960/nh.02680. Spanish.
- Joseph RP, Keller C, Adams MA, Ainsworth BE. Validity of two brief physical activity questionnaires with accelerometers among African-American women. Prim Health Care Res Dev. 2016 May;17(3):265-76. doi: 10.1017/S1463423615000390. Epub 2015 Jul 16.
- Kim BS, Kim JH, Park SH, Seo HS, Lee HS, Lee MM. Effect of a Respiratory Training Program Using Wind Instruments on Cardiopulmonary Function, Endurance, and Quality of Life of Elderly Women. Med Sci Monit. 2018 Jul 29;24:5271-5278. doi: 10.12659/MSM.909492.
- Lu WC, Tzeng NS, Kao YC, Yeh CB, Kuo TB, Chang CC, Chang HA. Correlation between health-related quality of life in the physical domain and heart rate variability in asymptomatic adults. Health Qual Life Outcomes. 2016 Oct 21;14(1):149. doi: 10.1186/s12955-016-0555-y.
- Marcos-Pardo PJ, Orquin-Castrillon FJ, Gea-Garcia GM, Menayo-Antunez R, Gonzalez-Galvez N, Vale RGS, Martinez-Rodriguez A. Effects of a moderate-to-high intensity resistance circuit training on fat mass, functional capacity, muscular strength, and quality of life in elderly: A randomized controlled trial. Sci Rep. 2019 May 24;9(1):7830. doi: 10.1038/s41598-019-44329-6.
- Mendonca GV, Pezarat-Correia P, Vaz JR, Silva L, Almeida ID, Heffernan KS. Impact of Exercise Training on Physiological Measures of Physical Fitness in the Elderly. Curr Aging Sci. 2016;9(4):240-259. doi: 10.2174/1874609809666160426120600.
- Millor N, Lecumberri P, Gomez M, Martinez A, Martinikorena J, Rodriguez-Manas L, Garcia-Garcia FJ, Izquierdo M. Gait Velocity and Chair Sit-Stand-Sit Performance Improves Current Frailty-Status Identification. IEEE Trans Neural Syst Rehabil Eng. 2017 Nov;25(11):2018-2025. doi: 10.1109/TNSRE.2017.2699124. Epub 2017 Apr 27.
- Perez-Sousa MA, Venegas-Sanabria LC, Chavarro-Carvajal DA, Cano-Gutierrez CA, Izquierdo M, Correa-Bautista JE, Ramirez-Velez R. Gait speed as a mediator of the effect of sarcopenia on dependency in activities of daily living. J Cachexia Sarcopenia Muscle. 2019 Oct;10(5):1009-1015. doi: 10.1002/jcsm.12444. Epub 2019 May 8.
- Raffin J, Barthelemy JC, Dupre C, Pichot V, Berger M, Feasson L, Busso T, Da Costa A, Colvez A, Montuy-Coquard C, Bouvier R, Bongue B, Roche F, Hupin D. Exercise Frequency Determines Heart Rate Variability Gains in Older People: A Meta-Analysis and Meta-Regression. Sports Med. 2019 May;49(5):719-729. doi: 10.1007/s40279-019-01097-7.
- Ramirez-Campillo R, Alvarez C, Garcia-Hermoso A, Celis-Morales C, Ramirez-Velez R, Gentil P, Izquierdo M. Reply to the commentary on: High-speed resistance training in elderly women: Effects of cluster training sets on functional performance and quality of life. Exp Gerontol. 2019 Aug;123:34-35. doi: 10.1016/j.exger.2019.05.012. Epub 2019 May 25. No abstract available.
- Ramirez-Velez R, Correa-Bautista JE, Garcia-Hermoso A, Cano CA, Izquierdo M. Reference values for handgrip strength and their association with intrinsic capacity domains among older adults. J Cachexia Sarcopenia Muscle. 2019 Apr;10(2):278-286. doi: 10.1002/jcsm.12373. Epub 2019 Mar 6.
- Ramirez-Velez R, Izquierdo M. Editorial: Precision Physical Activity and Exercise Prescriptions for Disease Prevention: The Effect of Interindividual Variability Under Different Training Approaches. Front Physiol. 2019 May 24;10:646. doi: 10.3389/fphys.2019.00646. eCollection 2019. No abstract available.
- Rodriguez-Manas L, Laosa O, Vellas B, Paolisso G, Topinkova E, Oliva-Moreno J, Bourdel-Marchasson I, Izquierdo M, Hood K, Zeyfang A, Gambassi G, Petrovic M, Hardman TC, Kelson MJ, Bautmans I, Abellan G, Barbieri M, Pena-Longobardo LM, Regueme SC, Calvani R, De Buyser S, Sinclair AJ; European MID-Frail Consortium. Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus. J Cachexia Sarcopenia Muscle. 2019 Aug;10(4):721-733. doi: 10.1002/jcsm.12432. Epub 2019 Apr 23.
- Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Casas-Herrero A, Ramirez-Velez R, Izquierdo M. Role of muscle power output as a mediator between gait variability and gait velocity in hospitalized older adults. Exp Gerontol. 2019 Sep;124:110631. doi: 10.1016/j.exger.2019.110631. Epub 2019 Jun 12.
- Saez de Asteasu ML, Martinez-Velilla N, Zambom-Ferraresi F, Casas-Herrero A, Izquierdo M. Role of physical exercise on cognitive function in healthy older adults: A systematic review of randomized clinical trials. Ageing Res Rev. 2017 Aug;37:117-134. doi: 10.1016/j.arr.2017.05.007. Epub 2017 Jun 3.
- Tan JPH, Beilharz JE, Vollmer-Conna U, Cvejic E. Heart rate variability as a marker of healthy ageing. Int J Cardiol. 2019 Jan 15;275:101-103. doi: 10.1016/j.ijcard.2018.08.005. Epub 2018 Aug 3.
- Taylor-Piliae RE, Fair JM, Haskell WL, Varady AN, Iribarren C, Hlatky MA, Go AS, Fortmann SP. Validation of the Stanford Brief Activity Survey: examining psychological factors and physical activity levels in older adults. J Phys Act Health. 2010 Jan;7(1):87-94. doi: 10.1123/jpah.7.1.87.
- Teodoro JL, da Silva LXN, Fritsch CG, Baroni BM, Grazioli R, Boeno FP, Lopez P, Gentil P, Bottaro M, Pinto RS, Izquierdo M, Cadore EL. Concurrent training performed with and without repetitions to failure in older men: A randomized clinical trial. Scand J Med Sci Sports. 2019 Aug;29(8):1141-1152. doi: 10.1111/sms.13451. Epub 2019 May 22.
- Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM, Santed R, Valderas JM, Ribera A, Domingo-Salvany A, Alonso J. [The Spanish version of the Short Form 36 Health Survey: a decade of experience and new developments]. Gac Sanit. 2005 Mar-Apr;19(2):135-50. doi: 10.1157/13074369. Spanish.
- Ball TJ, Joy EA, Goh TL, Hannon JC, Gren LH, Shaw JM. Validity of two brief primary care physical activity questionnaires with accelerometry in clinic staff. Prim Health Care Res Dev. 2015 Jan;16(1):100-8. doi: 10.1017/S1463423613000479. Epub 2014 Jan 28.
- Jofre-Saldia E, Villalobos-Gorigoitia A, Gea-Garcia G. Effects of multicomponent exercise program with progressive phases on functional capacity, fitness, quality of life, dual-task and physiological variables in older adults: Randomized controlled trial protocol. Rev Esp Geriatr Gerontol. 2021 Sep-Oct;56(5):272-278. doi: 10.1016/j.regg.2021.04.006. Epub 2021 Jun 8.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EJofre
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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