NEUROmuscular Training for Enhanced AGE Longevity (NEUROAGE)

University of Valencia

Status: Active, not recruiting

Conditions: Aging; Physical Activity; Training

Treatments: Dietary Supplement: Control + Dietary supplement (CDSII); 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 maximum strength resistance training + Placebo (EBMaxPl); Dietary Supplement: Active Comparator: Aerobic training + Placebo (AerPl); Dietary Supplement: Water-based power resistance training + Dietary supplement I (WPowDSI); Dietary Supplement: Water-based power resistance training + Placebo (WPowPl); Dietary Supplement: Control + Placebo (CPl); 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: Control + Dietary supplement I (CDSI)

Study type: Interventional

Funder types: Other

Identifiers

NCT06620666

CIACIF/2021/189 (Other Grant/Funding Number)

1861154

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 12 patient groups, including a placebo group

Water-based power resistance training + Dietary supplement I (WPowDSI)

Experimental group

Treatment:

Dietary Supplement: Water-based power resistance training + Dietary supplement I (WPowDSI)

Water-based power resistance training + Placebo (WPowPl)

Active Comparator group

Treatment:

Dietary Supplement: Water-based power resistance training + Placebo (WPowPl)

Elastic band-based power resistance training + Dietary supplement I (EBPowDSI)

Experimental group

Treatment:

Dietary Supplement: Elastic band-based power resistance training + Dietary supplement I (EBPowDSI)

Elastic band-based power resistance training + Placebo (EBPowPl)

Active Comparator group

Treatment:

Dietary Supplement: Elastic band-based power resistance training + Placebo (EBPowPl)

Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII)

Experimental group

Treatment:

Dietary Supplement: Elastic band-based eccentric resistance training + Dietary supplement II (EBEccDSII)

Elastic band-based eccentric resistance training + Placebo (EBEccPl)

Active Comparator group

Treatment:

Dietary Supplement: Elastic band-based eccentric resistance training + Placebo (EBEccPl)

Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII)

Experimental group

Treatment:

Dietary Supplement: Elastic band-based maximum strength resistance training + Dietary supplement II (EBMaxDSII)

Elastic band-based maximum strength resistance training + Placebo (EBMaxPl)

Active Comparator group

Treatment:

Dietary Supplement: Elastic band-based maximum strength resistance training + Placebo (EBMaxPl)

Control + Dietary supplement I (CDSI)

Active Comparator group

Treatment:

Dietary Supplement: Control + Dietary supplement I (CDSI)

Control + Dietary supplement II (CDSII)

Active Comparator group

Treatment:

Dietary Supplement: Control + Dietary supplement (CDSII)

Control + Placebo (CPl)

Placebo Comparator group

Treatment:

Dietary Supplement: Control + Placebo (CPl)

Aerobic training + Placebo (AerPl)

Active Comparator group

Treatment:

Dietary Supplement: Active Comparator: Aerobic training + Placebo (AerPl)