NEUROmuscular Training for Enhanced AGE Longevity (NEUROAGE)

Improvement of Biological and Functional Longevity Through Advanced Neuromuscular Training Protocols and Resources in Adulthood.

In recent years the research group on Prevention and Health in Exercise and Sport (PHES) has carried out numerous studies that have provided current and convincing evidence of the benefits of physical activity and exercise for chronic health, but unfortunately it has also shown that if physical exercise is not properly prescribed it can impair health, as well as accelerating the ageing process.

The research proposal presented here aims to reveal some of the forms of physical exercise and resources for its application that may be most beneficial for people's health, thus trying to find reliable evidence that will increase healthy longevity and quality of life in society.

Based on the above, and taking into account that the possible beneficial adaptations for health are specific to the applied form of physical exercise and the equipment used during its development, the PHES research group wishes to investigate the most appropriate strategies to ensure an active and positive ageing process.

With these relevant findings the researchers can create specific action plans for prevention and promotion through physical exercise in order to improve both health and quality of life expectancy.

The general objective of the project is to identify the most advanced methods and material resources with which to guarantee a beneficial process of active and healthy ageing with chronic training, so that with these relevant findings, concrete action plans can be created for prevention and promotion through physical exercise in order to improve both health and quality of life expectancy.

The specific objectives are the following:

• To validate new, specific, safe, and efficient tools to monitor the intensity of neuromuscular strength training activities in older adults.
• To analyze and compare the chronic effects of different cardiovascular and neuromuscular strength training modalities applied with different materials on cellular ageing, body composition, metabolic, and immune profiles, cognitive function, motor function, quality of life and well-being in older adults.
• To evaluate the efficacy of the use of dietary supplements to reduce or even stop the chronic adverse effects that different physical activity levels and/or physical exercise programs can have on the oxidative and inflammatory profile, body composition and metabolic profile, muscle and DNA damage, and physical performance in older adults.

Study Overview

• Status: Active, not recruiting
• Conditions: Physical Activity; Aging; Training
• Intervention / Treatment: Dietary supplement: Water-based power resistance training + Dietary supplement I (WPowDSI); Dietary supplement: Water-based power resistance training + Placebo (WPowPl); Dietary supplement: Elastic band-based power resistance training + Dietary supplement I (EBPowDSI); Dietary supplement: Elastic band-based power resistance training + Placebo (EBPowPl); Dietary supplement: Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII); Dietary supplement: Elastic band-based eccentric resistance training + Placebo (EBEccPl); Dietary supplement: Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII); Dietary supplement: Elastic band-based maximum strength resistance training + Placebo (EBMaxPl); Dietary supplement: Control + Dietary supplement I (CDSI); Dietary supplement: Control + Dietary supplement (CDSII); Dietary supplement: Control + Placebo (CPl); Dietary supplement: Active Comparator: Aerobic training + Placebo (AerPl)

Detailed Description

The project presented here will consist of two stages:

(i) Stage 1 "Validation studies": They consist in the development of validation of perceptual tools for pre-exercise quantification of the intensity of the training protocols with different training materials and methodologies; The research in this first stage will take the form of a descriptive cross-sectional perceptual estimation studies. Therefore, this first stage of research will be performed prior to the application of the chronic studies, and they will focus on validating resources for the proper control of intensity during the application of resistance training in elderly individuals by using measures of pre-exercise perceived exertion. If these concepts are validated, the researchers could state that will have created easily applicable and universal tools that will help to extend the appropriate use resistance training in older adults with highly accessible materials and conditions that can be applied internationally.

(ii) Stage 2 "Chronic studies": They consist in the development of different intervention protocols to analyze the chronic effects of different regime of methodologies, materials, and food supplementation. The research project presented here will continue in these second stages with prospective experimental studies of randomized intervention with older adults with pre-, and post-treatment measurements. The study population will be older adults belonging to a convenience sample who will participate voluntarily. The study at this stage will consist of carrying out different intervention protocols over a period of 12-16 weeks.

All the training programs of the chronic studies will start with familiarization sessions. During the first familiarization sessions, participants will be instructed on how to obtain the measure of the perceived exertion scale appropriate to the exercise intensity to be developed and also how to correctly perform the exercises of the training program. As for the training plan, in the different experimental groups, participants will complete a list of exercises prescribed by the technicians, which will be repeated in each session throughout the training plan. Participants assigned to the sedentary control groups will be asked to continue with their normal diet and activities during the weeks of the study and will be prohibited from participating in any physical activity program or weight loss plan. In contrast, the experimental groups will perform a strength training program with the modality-specific method developed and with the type of material and/or dietary supplement that corresponds to them according to the experimental design at a frequency of 2-3 days per week for 12-16 weeks. The standard exercise session will have a protocolized structure with a warm-up, a main exercise part and a cool-down.

• Study Type: Interventional
• Enrollment (Actual): 390
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia
    • Valencia, Valencia, Spain, 46020
      • Physical Activity and Sport Science Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Sedentary adults (≥ 60 years), i.e., no physical exercise.
• Physically independent (able to walk 100 m without a walking aid and climb 10 steps without rest).
• Medical certificate of suitability or fitness to practice resistance training activities.
• Cognitive ability to understand and follow the instructions and sign the informed consent form.
• Free of any antioxidant supplements for at least six weeks before the start of this study: Vitamin C, Vitamin E, Vitamin A (beta-carotene), Zinc, Coenzyme Q (CoenzymeQ10), turmeric, Omega 3, creatine monohydrate or multivitamin products containing any of these compounds.
• Do not smoke more than 5 cigarettes per day or consume distilled alcoholic beverages on a daily basis.

Exclusion Criteria:

• Presence of cardiovascular, musculoskeletal, renal, liver, pulmonary, or neuromuscular and neurological disorders that would prevent the participant from performing the exercises.
• A history of malignant neoplasms.
• Terminal illness with life expectancy of less than one year.
• Mini mental State Examination lower than 23/30.
• Severe visual or hearing impairment.
• Body weight changes at 10% in the previous year.
• Intake of prescription medications or supplements (e.g., vitamins C, E) that were expected to alter the results of the study (ergogenic, dietary aids, estrogen, beta-blockers, steroid hormones, calcitonin, corticosteroids, glucocorticoids, thiazide diuretics, anticonvulsants, bisphosphonates, raloxifene).
• Current or prior (past six months) use of hormone replacement therapy.
• Engagement in regular strength training (more than once a week) during the previous six months.
• Participation in another research project (within the last six months) involving dietary, exercise, and/or pharmaceutical intervention.
• Not be under pharmacological treatment with allopurinol (trade name Zyloric).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Water-based power resistance training + Dietary supplement I (WPowDSI)	Dietary supplement: Water-based power resistance training + Dietary supplement I (WPowDSI); The WPowDSI group will perform 8 repetitions per exercise (arm fly and swing, small and big kick, and a combined upper and lower limb exercise). Regarding the perceived exertion rating, a value of 4 (1º repetition) and 7 (last repetition) was recorded, accorded to an adaptation of the OMNI-RES scale in water in the remaining 12-16 weeks. The number of sets throughout the entire intervention was 4 sets per exercise, with 90s of active recovery (slow rhythmic swinging of the extremities) between sets. The speed of execution of the exercises was controlled using a metronome marking the cadence (concentric phase as fast as possible; eccentric phase 2s). Devices were used according to individual needs. Regarding supplementation, participants were randomly assigned to receive their daily dose.
Active Comparator: Water-based power resistance training + Placebo (WPowPl)	Dietary supplement: Water-based power resistance training + Placebo (WPowPl); The WPowCr group will perform 8 repetitions per exercise (arm fly and swing, small and big kick, and a combined upper and lower limb exercise). Regarding the perceived exertion rating, a value of 4 (1º repetition) and 7 (last repetition) was recorded, accorded to an adaptation of the OMNI-RES scale in water in the remaining 12-16 weeks. The number of sets throughout the entire intervention was 4 sets per exercise, with 90s of active recovery (slow rhythmic swinging of the extremities) between sets. The speed of execution of the exercises was controlled using a metronome marking the cadence (concentric phase as fast as possible; eccentric phase 2s). Devices were used according to individual needs. Regarding placebo, participants were randomly assigned to receive their daily dose.
Experimental: Elastic band-based power resistance training + Dietary supplement I (EBPowDSI)	Dietary supplement: Elastic band-based power resistance training + Dietary supplement I (EBPowDSI); The EBPowDSI group will perform 8 repetitions per exercise (militar press, squat, upright row, lunge, and push-press). Regarding the perceived exertion rating, a value of 4 (1º repetition) and 7 (last repetition), according to an adaptation of the OMNI-RES EB scale in the remaining 12-16 weeks. The number of sets throughout the entire intervention was 4 sets per exercise, with 90s of active recovery (slow rhythmic swinging of the extremities) between sets and 90s of rest between exercises. The speed of execution of the exercises was controlled using a metronome marking the cadence (concentric phase: as fast as possible; eccentric phase: 2s). Regarding supplementation, participants were randomly assigned to receive their daily dose.
Active Comparator: Elastic band-based power resistance training + Placebo (EBPowPl)	Dietary supplement: Elastic band-based power resistance training + Placebo (EBPowPl); The EBPotPl group will perform 8 repetitions per exercise (militar press, squat, upright row, lunge, and push-press). Regarding the perceived exertion rating, a value of 4 (1º repetition,) and 7 (last repetition), according to an adaptation of the OMNI-RES EB scale in the remaining 16 weeks. The number of sets throughout the entire intervention was 4 sets per exercise, with 90s of active recovery (slow rhythmic swinging of the extremities) between sets and 90s of rest between exercises. The speed of execution of the exercises was controlled using a metronome marking the cadence (concentric phase: as fast as possible; eccentric phase: 2s). Regarding placebo, participants were randomly assigned to receive their daily dose.
Experimental: Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII)	Dietary supplement: Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII); The EBEccDSII group will perform 6 repetitions per exercise (lunge, chest press, hiptrust and standing row). The exercises were performed at maximum intensity until the point where stability or technique was lost, prior the stretching of the band. The number of sets throughout the entire intervention was 4 sets per exercise, with 120s of active recovery between sets and 90s of rest between exercises. The pace of execution of the exercises was controlled using a metronome marking the cadence (concentric phase: until reaching the stretching of the band; eccentric phase: 5s). Regarding supplementation, participants were randomly assigned to receive their daily dose.
Active Comparator: Elastic band-based eccentric resistance training + Placebo (EBEccPl)	Dietary supplement: Elastic band-based eccentric resistance training + Placebo (EBEccPl); The EBEccPl group will perform 6 repetitions per exercise (lunge, chest press, hiptrust and standing row). The exercises were performed at maximum intensity until the point where stability or technique was lost, prior the stretching of the band. The number of sets throughout the entire intervention was 4 sets per exercise, with 120s of active recovery between sets and 90s of rest between exercises. The pace of execution of the exercises was controlled using a metronome marking the cadence (concentric phase: until reaching the stretching of the band; eccentric phase: 5s). Regarding placebo, participants were randomly assigned to receive their daily dose.
Experimental: Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII)	Dietary supplement: Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII); The EBMaxDSII group will perform 6 repetitions per exercise (lunge, chest press, hiptrust and standing row). Regarding the perceived exertion rating, a value of 7 (1º repetition,) and 9 (last repetition), according to an adaptation of the OMNI-RES EB scale in the remaining 16 weeks. The number of sets throughout the entire intervention was 4 sets per exercise, with 120s of active recovery between sets and 90s of rest between exercises. The pace of execution of the exercises was controlled using a metronome marking the cadence (concentric-eccentric phase: 2s). Regarding supplementation, participants were randomly assigned to receive their daily dose.
Active Comparator: Elastic band-based maximum strength resistance training + Placebo (EBMaxPl)	Dietary supplement: Elastic band-based maximum strength resistance training + Placebo (EBMaxPl); The EBMaxPl group will perform 6 repetitions per exercise (lunge, chest press, hiptrust and standing row). Regarding the perceived exertion rating, a value of 7 (1º repetition,) and 9 (last repetition), according to an adaptation of the OMNI-RES EB scale in the remaining 16 weeks. The number of sets throughout the entire intervention was 4 sets per exercise, with 120s of active recovery between sets and 90s of rest between exercises. The pace of execution of the exercises was controlled using a metronome marking the cadence (concentric-eccentric phase: 2s). Regarding placebo, participants were randomly assigned to receive their daily dose.
Active Comparator: Control + Dietary supplement I (CDSI)	Dietary supplement: Control + Dietary supplement I (CDSI); Participants randomized into the control group will not undertake any formal intervention and will be asked to maintain their usual physical activity habits and diet. Regarding supplementation, participants were randomly assigned to receive their daily dose.
Active Comparator: Control + Dietary supplement II (CDSII)	Dietary supplement: Control + Dietary supplement (CDSII); Participants randomized into the control group will not undertake any formal intervention and will be asked to maintain their usual physical activity habits and diet. Regarding supplementation, participants were randomly assigned to receive their daily dose.
Placebo Comparator: Control + Placebo (CPl)	Dietary supplement: Control + Placebo (CPl); Participants randomized into the control group will not undertake any formal intervention and will be asked to maintain their usual physical activity habits and diet. Regarding placebo, participants were randomly assigned to receive their daily dose.
Active Comparator: Aerobic training + Placebo (AerPl)	Dietary supplement: Active Comparator: Aerobic training + Placebo (AerPl); The group will perform aerobic exercise for 20-40 minutes with easy execution exercise. Regarding placebo, participants were randomly assigned to receive their daily dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lipid peroxidation	The lipid peroxidation will be assessed via blood collections of 8-isoprostaglandin (nmol /mmol)	Baseline and 12-16 weeks
Change in antioxidants enzymes	The antioxidants enzymes will be assessed via blood collections of glutathione peroxidase (IU/g Hb).	Baseline and 12-16 weeks
Change in brain neuroplasticity	The brain neuroplasticity will be assessed via blood collections of brain-derived neurotrophic factor (BDNF) (ng/ml)	Baseline and 12-16 weeks
Change in inflammatory profile	The interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-α) (pg/mL) will be assessed via blood collections.	Baseline and 12-16 weeks
Change in bone metabolism I (Formation)	The bone metabolism will be assessed via blood collections of Type I procollagen N-terminal propeptide (P1NP) are marker of bone formation.	Baseline and 12-16 weeks
Change in bone metabolism II (Resorption)	The bone metabolism will be assessed via blood collections of terminal telopeptide of collagen type I (β-CTX- 1) which is a marker of bone resoption.	Baseline and 12-16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood pressure	Systolic and diastolic blood pressure (mmHg) will be measured	Baseline and 12-16 weeks
Change in renal and hepatic profile I	Glutamic-oxaloacetic transaminase (U/L) will be measured.	Baseline and 12-16 weeks
Change in renal and hepatic profile II	Creatine (mg/dL) will be measured.	Baseline and 12-16 weeks
Change in lipid profile	The lipid profile will be assessed via blood collections: total cholesterol (mg/dL), high-density lipoprotein cholesterol (mg/dL), low-density lipoprotein cholesterol (mg/dL) and triglycerides (mg/dL).	Baseline and 12-16 weeks
Change in metabolic profile I	The metabolic profile will be assessed via blood collections of basal glucose (mmol/l).	Baseline and 12-16 weeks
Change in metabolic profile II	The metabolic profile will be assessed via blood collections of human ghrelin (GHRL) (pg/ml), human acylated ghrelin (AG) (pg/ml), human glucagon like peptide 1 (GLP1) (pg/ml), and human cholecystokinin (CCK) (pg/ml).	Baseline and 12-16 weeks
Change in metabolic profile III	The metabolic profile will be assessed via blood collections of leptin (ng/mL).	Baseline and 12-16 weeks
Change in metabolic profile IV	The metabolic profile will be assessed via blood collections of human peptide YY (PYY) (10 µCi).	Baseline and 12-16 weeks
Change in cognitive function I	The cognitive function will be assessed by the Trail Making Test (TMT) questionnaire (seconds; mistakes).	Baseline and 12-16 weeks
Change in cognitive function II	It will be assessed through the application of the MMSE. This test evaluates cognitive impairment, it contains 28 closed questions that measure 8 of the 11 main aspects of cognitive status.	Baseline and 12-16 weeks
Change in cognitive function III	It will be measured by Wisconsin Card Sorting Test (WCST). This test measures abstraction ability, concept formation, and cognitive strategy change in response to changes in environmental contingencies.	Baseline and 12-16 weeks
Change in cognitive function IV	It will be measured by Vienna Test System (VTS). Specifically, will be use the Determination Test (DT), and Reaction Test (RT). This tests are used to check the capacity of observation and visual control, as well as the visual capacity of orientation and the speed of comprehension.	Baseline and 12-16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in isokinetic muscle strength	The dynamic maximal concentric muscle strength of the dominant side of knee, elbow, and shoulder (flexion and extension muscle groups) will be measured with an isokinetic dynamometer (Biodex System 4 Pro; Biodex, Shirley, NY) at two angular velocities, 60°/s and 180°/s. Maximal voluntary concentric isokinetic torque will be assessed in Newton-meters (N-m).	Baseline and 12-16 weeks
Change in maximal muscle hand grip strength	The isometric maximal muscle hand grip strength of both hands will be measured with a dynamometer (kg).	Baseline and 12-16 weeks
Change in fracture risk	Will be assessed via the FRAX ® tool (%).	Baseline and 12-16 weeks
Change T-Score	T-Score (SD) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Wards triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline and 12-16 weeks
Change in bone mineral density (BMD)	BMD (g/cm2) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Wards triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline and 12-16 weeks
Change bone mineral content (BMC)	BMC(g) will be assessed for whole body, proximal femur on the non-dominant side (femoral nech, trochanter, intertrochanter, Wards triangle and total hip) and lumbar spine segments (L1-L4) (L2-L4) (L1-L3) and single vertebrae (L1, L2, L3, L4) will be assessed using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA).	Baseline and 12-16 weeks
Change in self-reported quality of life	Will be assessed via Short form quality of life questionnaire (SF36) (0-100 points).	Baseline and 12-16 weeks
State of instrumental activities of daily living	Will be assessed via Lawton and Brody instrumental activities of daily living scale. There are eight domains of function measured with the Lawton and Brody scale. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent).	Baseline
State of basic activities of daily living	Will be assessed via Barthel index of activities of daily living (score 0-100).	Baseline
Attendance to training program	Adherence levels (%) will be calculated at the end of the training period. Nonadherence is define as those not attending at follow-up and have not attend for 4 weeks during the training period, and have not given a reason for nonattendance or those who have stated they are dropping out.	12-16 weeks
State of eye health I	The eye health will be measured with Visual Function index (VF14) (0-100 points). This test provides an subjective assessment of visual quality.	Baseline and 12-16 weeks
State of eye health II	The state of eye health will be measured with Functional Acuity Contrast Test (FACT) (log) associated with contrast sensitivity.	Baseline and 12-16 weeks
State of eye health III	The intraocular pressure will be measured using an iCare rebound tonometer (mmHg).	Baseline and 12-16 weeks
State of eye health IV	The ocular perfusion pressure (mmHg) will be calculate with a formula that includes intraocular pressure and blood pressure.	Baseline and 12-16 weeks
Change in neuropathic pain I	Neuropathic pain will be measured with Western Ontario and McMaster Universities Arthritis Index (WOMAC). This index is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: a) pain (0-20 points); b) stiffness (0-8 points); c) physical function (0-68 points).	Baseline and 12-16 weeks
Change in neuropathic pain II	Neuropathic pain will be measured with Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. This scale can be used to identify pain of predominantly neuropathic origin, thus distinguishing between neuropathic pain and nociceptive pain. The LANSS scale comprises of a 7-item pain scale (5 are symptom related, and 2 are examination items) (more than 12 points on the scale might also be suffering from neuropathic pain; less than 12 points on the scale might not be suffering from neuropathic pain).	Baseline and 12-16 weeks
Change in neuropathic pain III	Neuropathic pain will be measured with Visual Analogue Scale (VAS) scale. This scale measure the intensity or frequency of various symptoms (0-100 points; A higher score indicates greater pain intensity).	Baseline and 12-16 weeks
Change in neuropathic pain IV	Neuropathic pain will be measured with Neuropathic pain scale (NPS). This scale measures 10 specific qualities associated with neuropathic pain (0-10 points; A higher score indicates greater pain intensity).	Baseline and 12-16 weeks
Height	Height (cm) will be recorded to the nearest 0.01 cm using a stadiometer (Seca 711, Hamburg, Germany)	Baseline and 12-16 weeks
Weight	Weight (kg) will be measured with a bioelectrical impedance scale (Tanita model Tanita MC 780-P MA, Tokyo, Japan; precision 0.01 kg).	Baseline and 12-16 weeks
Body Mass Index	Weight and height will be combined to report body mass index (BMI) (kg/m^2 ).	Baseline and 12-16 weeks
Change in body composition I (Fat mass)	Fat mass (kg) will be assessed for whole body and appendicular/visceral regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). Furthermore, the same variable will be assessed using a bioelectrical impedance scale (Tanita model Tanita MC 780-P MA, Tokyo, Japan; precision 0.01 kg).	Baseline and 12-16 weeks
Change in body composition II (% Fat mass)	Percentage of fat mass (%) will be assessed for whole body and appendicular/visceral regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). Furthermore, the same variable will be assessed using a bioelectrical impedance scale (Tanita model Tanita MC 780-P MA, Tokyo, Japan; precision 0.01 kg).	Baseline and 12-16 weeks
Change in body composition III (Fat-free mass)	Fat-free mass (kg) will be assessed for whole body and appendicular/visceral regions using a dual-energy-X ray fan beam absorptiometry (QDR® Hologic Discovery Wi, Hologic Inc., Waltham, MA, USA) equipped with APEX software (APEX Corp., version 12.4, Waltham, MA, USA). Furthermore, the same variable will be assessed using a bioelectrical impedance scale (Tanita model MC 780-P MA, Tokyo, Japan; precision 0.01 kg).	Baseline and 12-16 weeks
State of nutritional status	Dietary intake will be assessed by applying the Mini Nutritional Assessment-short form (MNA-f1). This brief questionnaire consists of six items, which correspond to questions about decreased food consumption, weight loss, mobility, presence of acute illness, neuropsychological problems and anthropometry.	Baseline and 12-16 weeks
Change in balance I	Balance will be measured with Romberg test (points).	Baseline and 12-16 weeks
Change in balance II	Balance will be measured with Functional Reach Test (FRT) (cm).	Baseline and 12-16 weeks
Change in functional performance I	The functional performance will be assessed with Senior Fitness tests that involve 3 tests: Chair Stand (stand up from a chair as often as possible within 30s); Up-and-Go (for dynamic balance, time for got up from the chair, walk as quickly as possible around a cone placed 2.4 m from the chair, and resume the seated position); and Six-Minute walking test (for aerobic capacity, distance walked in 6 minutes).	Baseline and 12-16 weeks
Change in functional performance II	It will be measured by Short Physical Performance Battery (SPPB): This is a performance instrument that includes 3 tests: balance, walking speed and getting up and sitting down from a chair 5 times. Each test is scored from 0 (worst performance) to 4 (best performance). A total score is obtained for the entire battery, which is the sum of the 3 tests and ranges from 0 to 12 and is classified as: low performance (0-6 points); intermediate (7-9 points) and high performance (10-12 points)	Baseline and 12-16 weeks
Change in functional performance III	It will be measured by 2-Minute Step Test: The test considers the number of times the right knee reaches the individual reference height. If it does not reach the indicated height, the speed will be reduced so that the test is valid without stopping time. The score at the end will be given according to the number of steps taken, where the right knee reached the set height.	Baseline and 12-16 weeks
Change in depressive symptoms	It will be measured through the GDS-15 test, the most widely used screening scale for depression in older people, consisting of 15 questions, with a dichotomous yes/no response. Scores from 0 to 4 points are considered normal, 5-10 indicates mild depression, and scores greater than 10 indicate established depression	Baseline and 12-16 weeks
State of level of physical activity I	The level of physical activity (low, medium, high) of the participants will be assessed by Global Physical Activity Questionnaire (GPAQ) (min/week; MET/week).	Baseline and 12-16 weeks
State of level of physical activity II	The level of physical activity (low, medium, high) of the participants will be assessed by International Physical Activity Questionnaires (IPAQ) (min/week; MET/week).	Baseline and 12-16 weeks
Working heart rate	Working heart rate will be assessed with a Polar FT1 (Polar Electro, Tampere, Finland) (bpm). This variable will be measured in the first stage of the project (Validation studies.	Baseline and 12-16 weeks
Neuromuscular activation	Neuromuscular activation will be measured using electromyographic (EMG). The EMG signal will be obtained using two two-channel handheld devices (RealtimeTechnologies Ltd., Dublin, Ireland) with 16-bit analog-to-digital (A/D) conversion. EMGdata will be monitored using validated mDurance software for Android (mDuranceSolutions S.L., Granada, Spain). This variable will be measured in the first stage of the project (Validation studies).	Baseline and 4 weeks
Total repetitions performed	Total repetitions performed will be recorded for later analysis with photogrammetry and video techniques. This variable will be measured in the first stage of the project (Validation studies).	Baseline and 4 weeks
Maximum oxygen consumption	Will be measured using a portable metabolimeter (VO2 Master Health Sensors Inc., Canada) (ml/kg/min).	Baseline and 4 weeks
Capillary blood lactate	Blood lactate concentrations will be measured from capillary blood obtained from the fingertips. The samples were analyzed using a portablel actate analyzer (Lactate Pro 2, Arkray Inc., Kyoto, Japan) (mmol/L).	Baseline and 4 weeks
Rating of perceived exertion	Rating of perceived exertion will be measured with OMNI-Resistance Exercise Scale in the elderly (0-10 points). This variable will be measured in the first stage of the project (Validation studies).	Baseline and 4 weeks
Change in sleep quality	It will be assessed by the Pittsburgh Sleep Quality Questionnaire. This instrument provides an overall score of subjects sleep quality and 7 partial scores belonging to different partial scores pertaining to different components: subjective sleep quality, latency, duration, habitual efficiency, disturbances, use of hypnotic medication and daytime dysfunction. The questions refer to the last month. The score for each of the seven components ranges from 0 (no difficulty) to 3 (severe difficulty); the overall score ranges between 0 (no difficulty) and 21 (difficulties in all areas), with a cut-off point at score 5 to differentiate between good and bad sleepers.	Baseline and 12-16 weeks

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Generalitat Valenciana; Indiex Sport Nutrition Spail SL

Publications and helpful links

General Publications

• Fernandez-Garrido J, Martin EG, Saez-Berlanga A, Gargallo-Bayo P, Gene-Morales J, Alix-Fages C, Jimenez-Martinez P, Caballero O, Salvador-Palmer R, Colado JC. Effects of high-load, velocity-intentional variable resistance training combined with creatine supplementation on neuroplasticity, oxidative stress, inflammation, physical function, cognitive performance and quality of life in older adults: A randomized, double-blind, placebo-controlled trial. Exp Gerontol. 2026 Jun 1;218:113122. doi: 10.1016/j.exger.2026.113122. Epub 2026 Apr 4.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Oxidative stress; Physical activity; Body composition; Aging; Cognitive function; DNA damage; Dose-response; Bone health; Strength training; Dietary supplements; Physical performance; Metabolic profile; Immunological profile; Inflammatory profile; Variable resistance training; Exercise modalities; Exercise intensities; Neuromuscular physiology; Cellular aging; Training devices
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements
• Other Study ID Numbers: 1861154; CIACIF/2021/189 (Other Grant/Funding Number: Department of Education, Culture, Universities, and Employment of the Valencian Government (Spain))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No