AgingNEUROAGENCT06620666
NEUROmuscular Training for Enhanced AGE Longevity
A study testing Water-based power resistance training + Dietary supplement I (WPowDSI), Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) and Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) in people with Aging and Physical Activity, run by University of Valencia at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Physical Activity, Training
- What is being tested?
- Water-based power resistance training + Dietary supplement I (WPowDSI), Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) and Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jan 2024to 15 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Physical Activity and Sport Science Faculty
Valencia, Valencia, 46020
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Aging, Physical Activity, Training
- Being tested
- Water-based power resistance training + Dietary supplement I (WPowDSI), Water-based power resistance training + Placebo (WPowPl), Elastic band-based power resistance training + Dietary supplement I (EBPowDSI), Elastic band-based power resistance training + Placebo (EBPowPl), Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII)
- Keywords
- Aging, Dose-response, Variable resistance training, Exercise modalities, Exercise intensities, Oxidative stress, Bone health, Neuromuscular physiology, Physical activity, Cellular aging, Training devices, Dietary supplements, Strength training, Cognitive function, Body composition, Metabolic profile, Inflammatory profile, Immunological profile, Physical performance, DNA damage
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-based power resistance training + Dietary supplement I (WPowDSI)Dietary supplement
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.
Water-based power resistance training + Placebo (WPowPl)Dietary supplement
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.
Elastic band-based power resistance training + Dietary supplement I (EBPowDSI)Dietary supplement
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.
Elastic band-based power resistance training + Placebo (EBPowPl)Dietary supplement
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.
Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII)Dietary supplement
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.
Elastic band-based eccentric resistance training + Placebo (EBEccPl)Dietary supplement
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.
Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII)Dietary supplement
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.
Elastic band-based maximum strength resistance training + Placebo (EBMaxPl)Dietary supplement
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.
Control + Placebo (CPl)Dietary supplement
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.
Control + Dietary supplement I (CDSI)Dietary supplement
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.
Control + Dietary supplement (CDSII)Dietary supplement
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: Aerobic training + Placebo (AerPl)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Water-based power resistance training + Dietary supplement I (WPowDSI) | Experimental | Not described Receives: Dietary Supplement: Water-based power resistance training + Dietary supplement I (WPowDSI) |
| Water-based power resistance training + Placebo (WPowPl) | Active comparator | Not described Receives: Dietary Supplement: Water-based power resistance training + Placebo (WPowPl) |
| Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) | Experimental | Not described Receives: Dietary Supplement: Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) |
| Elastic band-based power resistance training + Placebo (EBPowPl) | Active comparator | Not described Receives: Dietary Supplement: Elastic band-based power resistance training + Placebo (EBPowPl) |
| Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) | Experimental | Not described Receives: Dietary Supplement: Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) |
| Elastic band-based eccentric resistance training + Placebo (EBEccPl) | Active comparator | Not described Receives: Dietary Supplement: Elastic band-based eccentric resistance training + Placebo (EBEccPl) |
| Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII) | Experimental | Not described Receives: Dietary Supplement: Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII) |
| Elastic band-based maximum strength resistance training + Placebo (EBMaxPl) | Active comparator | Not described Receives: Dietary Supplement: Elastic band-based maximum strength resistance training + Placebo (EBMaxPl) |
| Control + Dietary supplement I (CDSI) | Active comparator | Not described Receives: Dietary Supplement: Control + Dietary supplement I (CDSI) |
| Control + Dietary supplement II (CDSII) | Active comparator | Not described Receives: Dietary Supplement: Control + Dietary supplement (CDSII) |
| Control + Placebo (CPl) | Placebo comparator | Not described Receives: Dietary Supplement: Control + Placebo (CPl) |
| Aerobic training + Placebo (AerPl) | Active comparator | Not described Receives: Dietary Supplement: Active Comparator: Aerobic training + Placebo (AerPl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipid peroxidation
The lipid peroxidation will be assessed via blood collections of 8-isoprostaglandin (nmol /mmol)
Measured: Baseline and 12-16 weeks
Change in antioxidants enzymes
The antioxidants enzymes will be assessed via blood collections of glutathione peroxidase (IU/g Hb).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12-16 weeks
Secondary outcomes (12)
Change in blood pressure
Systolic and diastolic blood pressure (mmHg) will be measured
Measured: Baseline and 12-16 weeks
Change in renal and hepatic profile I
Glutamic-oxaloacetic transaminase (U/L) will be measured.
Measured: Baseline and 12-16 weeks
Change in renal and hepatic profile II
Creatine (mg/dL) will be measured.
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).
Measured: Baseline and 12-16 weeks
Change in metabolic profile I
The metabolic profile will be assessed via blood collections of basal glucose (mmol/l).
Measured: 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).
Measured: Baseline and 12-16 weeks
Change in metabolic profile III
The metabolic profile will be assessed via blood collections of leptin (ng/mL).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start24 Jan 2024
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, duoble-blind (sport scientiest assistance/care assistance-outcome assessor), 12 arms prospective parallel design clinical trial. The older adults will be recruited from the researchers setting and will be randomized in a prospective clinical trial study with a 12 parallel arms study design to a resistance training modalities performed at different intensities or a control groups over a 12-16 weeks period.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Generalitat Valenciana, Indiex Sport Nutrition Spail SL
- Responsible party
- Principal investigator, Juan C. Colado, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620666
- Sponsor's protocol ID
- 1861154
- Other IDs
- CIACIF/2021/189
- Acronym
- NEUROAGE
- Status last verified
- May 2026
- First submitted
- 18 Sep 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 41941966
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Biological and Functional Longevity Through Advanced Neuromuscular Training Protocols and Resources in Adulthood.
- ClinicalTrials.gov ID
- NCT06620666
- Acronym / sponsor ID
- NEUROAGE / 1861154
- Conditions
- Aging, Physical Activity, Training
- Keywords
- Aging, Dose-response, Variable resistance training, Exercise modalities, Exercise intensities, Oxidative stress, Bone health, Neuromuscular physiology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 390 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Generalitat Valenciana, Indiex Sport Nutrition Spail SL
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 12
- Model description
- This is a randomized, duoble-blind (sport scientiest assistance/care assistance-outcome assessor), 12 arms prospective parallel design clinical trial. The older adults will be recruited from the researchers setting and will be randomized in a prospective clinical trial study with a 12 parallel arms study design to a resistance training modalities performed at different intensities or a control groups over a 12-16 weeks period.
| Arm | Type | Receives |
|---|---|---|
| Water-based power resistance training + Dietary supplement I (WPowDSI) | Experimental | Dietary Supplement: Water-based power resistance training + Dietary supplement I (WPowDSI) |
| Water-based power resistance training + Placebo (WPowPl) | Active comparator | Dietary Supplement: Water-based power resistance training + Placebo (WPowPl) |
| Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) | Experimental | Dietary Supplement: Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) |
| Elastic band-based power resistance training + Placebo (EBPowPl) | Active comparator | Dietary Supplement: Elastic band-based power resistance training + Placebo (EBPowPl) |
| Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) | Experimental | Dietary Supplement: Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) |
| Elastic band-based eccentric resistance training + Placebo (EBEccPl) | Active comparator | Dietary Supplement: Elastic band-based eccentric resistance training + Placebo (EBEccPl) |
| Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII) | Experimental | Dietary Supplement: Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII) |
| Elastic band-based maximum strength resistance training + Placebo (EBMaxPl) | Active comparator | Dietary Supplement: Elastic band-based maximum strength resistance training + Placebo (EBMaxPl) |
| Control + Dietary supplement I (CDSI) | Active comparator | Dietary Supplement: Control + Dietary supplement I (CDSI) |
| Control + Dietary supplement II (CDSII) | Active comparator | Dietary Supplement: Control + Dietary supplement (CDSII) |
| Control + Placebo (CPl) | Placebo comparator | Dietary Supplement: Control + Placebo (CPl) |
| Aerobic training + Placebo (AerPl) | Active comparator | Dietary Supplement: Active Comparator: Aerobic training + Placebo (AerPl) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Water-based power resistance training + Dietary supplement I (WPowDSI) |
| 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. | Dietary supplement | Water-based power resistance training + Placebo (WPowPl) |
| 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. | Dietary supplement | Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) |
| 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. | Dietary supplement | Elastic band-based power resistance training + Placebo (EBPowPl) |
| 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. | Dietary supplement | Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) |
| 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. | Dietary supplement | Elastic band-based eccentric resistance training + Placebo (EBEccPl) |
| 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. | Dietary supplement | Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII) |
| 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. | Dietary supplement | Elastic band-based maximum strength resistance training + Placebo (EBMaxPl) |
| 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. | Dietary supplement | Control + Placebo (CPl) |
| 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. | Dietary supplement | Control + Dietary supplement I (CDSI) |
| 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. | Dietary supplement | Control + Dietary supplement II (CDSII) |
| 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. | Dietary supplement | Aerobic training + Placebo (AerPl) |
Primary outcome
Change in lipid peroxidation
Time frame: Baseline and 12-16 weeks
The lipid peroxidation will be assessed via blood collections of 8-isoprostaglandin (nmol /mmol)
Change in antioxidants enzymes
Time frame: Baseline and 12-16 weeks
The antioxidants enzymes will be assessed via blood collections of glutathione peroxidase (IU/g Hb).
Change in brain neuroplasticity
Time frame: Baseline and 12-16 weeks
The brain neuroplasticity will be assessed via blood collections of brain-derived neurotrophic factor (BDNF) (ng/ml)
Change in inflammatory profile
Time frame: Baseline and 12-16 weeks
The interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF-α) (pg/mL) will be assessed via blood collections.
Change in bone metabolism I (Formation)
Time frame: Baseline and 12-16 weeks
The bone metabolism will be assessed via blood collections of Type I procollagen N-terminal propeptide (P1NP) are marker of bone formation.
Change in bone metabolism II (Resorption)
Time frame: Baseline and 12-16 weeks
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.
12 secondary outcomes
Change in blood pressure
Time frame: Baseline and 12-16 weeks
Change in renal and hepatic profile I
Time frame: Baseline and 12-16 weeks
Change in renal and hepatic profile II
Time frame: Baseline and 12-16 weeks
Change in lipid profile
Time frame: Baseline and 12-16 weeks
Change in metabolic profile I
Time frame: Baseline and 12-16 weeks
Change in metabolic profile II
Time frame: Baseline and 12-16 weeks
Change in metabolic profile III
Time frame: Baseline and 12-16 weeks
Change in metabolic profile IV
Time frame: Baseline and 12-16 weeks
Change in cognitive function I
Time frame: Baseline and 12-16 weeks
Change in cognitive function II
Time frame: Baseline and 12-16 weeks
Change in cognitive function III
Time frame: Baseline and 12-16 weeks
Change in cognitive function IV
Time frame: Baseline and 12-16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Derived from this study: PubMed 41941966Fernandez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-based power resistance training + Dietary supplement I (WPowDSI), Elastic band-based power resistance training + Dietary supplement I (EBPowDSI) and Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII) in people with Aging and Physical Activity, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipid peroxidation (time frame: Baseline and 12-16 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.