Clinical trial NCT06620666: NEUROmuscular Training for Enhanced AGE Longevity
Official title: Improvement of Biological and Functional Longevity Through Advanced Neuromuscular Training Protocols and Resources in Adulthood.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aging
Physical Activity
Training
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
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Generalitat Valenciana
name: Indiex Sport Nutrition Spail SL
First posted: 2024-10-01
Enrollment: 390
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in lipid peroxidation
timeFrame: Baseline and 12-16 weeks
measure: Change in antioxidants enzymes
timeFrame: Baseline and 12-16 weeks
measure: Change in brain neuroplasticity
timeFrame: Baseline and 12-16 weeks
measure: Change in inflammatory profile
timeFrame: Baseline and 12-16 weeks
measure: Change in bone metabolism I (Formation)
timeFrame: Baseline and 12-16 weeks
measure: Change in bone metabolism II (Resorption)
timeFrame: Baseline and 12-16 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline and 12-16 weeks
measure: Change in renal and hepatic profile I
timeFrame: Baseline and 12-16 weeks
measure: Change in renal and hepatic profile II
timeFrame: Baseline and 12-16 weeks
measure: Change in lipid profile
timeFrame: Baseline and 12-16 weeks
measure: Change in metabolic profile I
timeFrame: Baseline and 12-16 weeks
measure: Change in metabolic profile II
timeFrame: Baseline and 12-16 weeks
measure: Change in metabolic profile III
timeFrame: Baseline and 12-16 weeks
measure: Change in metabolic profile IV
timeFrame: Baseline and 12-16 weeks
measure: Change in cognitive function I
timeFrame: Baseline and 12-16 weeks
measure: Change in cognitive function II
timeFrame: Baseline and 12-16 weeks
measure: Change in cognitive function III
timeFrame: Baseline and 12-16 weeks
measure: Change in cognitive function IV
timeFrame: Baseline and 12-16 weeks
Other outcomes:
measure: Change in isokinetic muscle strength
timeFrame: Baseline and 12-16 weeks
measure: Change in maximal muscle hand grip strength
timeFrame: Baseline and 12-16 weeks
measure: Change in fracture risk
timeFrame: Baseline and 12-16 weeks
measure: Change T-Score
timeFrame: Baseline and 12-16 weeks
measure: Change in bone mineral density (BMD)
timeFrame: Baseline and 12-16 weeks
measure: Change bone mineral content (BMC)
timeFrame: Baseline and 12-16 weeks
measure: Change in self-reported quality of life
timeFrame: Baseline and 12-16 weeks
measure: State of instrumental activities of daily living
timeFrame: Baseline
measure: State of basic activities of daily living
timeFrame: Baseline
measure: Attendance to training program
timeFrame: 12-16 weeks
measure: State of eye health I
timeFrame: Baseline and 12-16 weeks
measure: State of eye health II
timeFrame: Baseline and 12-16 weeks
measure: State of eye health III
timeFrame: Baseline and 12-16 weeks
measure: State of eye health IV
timeFrame: Baseline and 12-16 weeks
measure: Change in neuropathic pain I
timeFrame: Baseline and 12-16 weeks
measure: Change in neuropathic pain II
timeFrame: Baseline and 12-16 weeks
measure: Change in neuropathic pain III
timeFrame: Baseline and 12-16 weeks
measure: Change in neuropathic pain IV
timeFrame: Baseline and 12-16 weeks
measure: Height
timeFrame: Baseline and 12-16 weeks
measure: Weight
timeFrame: Baseline and 12-16 weeks
measure: Body Mass Index
timeFrame: Baseline and 12-16 weeks
measure: Change in body composition I (Fat mass)
timeFrame: Baseline and 12-16 weeks
measure: Change in body composition II (% Fat mass)
timeFrame: Baseline and 12-16 weeks
measure: Change in body composition III (Fat-free mass)
timeFrame: Baseline and 12-16 weeks
measure: State of nutritional status
timeFrame: Baseline and 12-16 weeks
measure: Change in balance I
timeFrame: Baseline and 12-16 weeks
measure: Change in balance II
timeFrame: Baseline and 12-16 weeks
measure: Change in functional performance I
timeFrame: Baseline and 12-16 weeks
measure: Change in functional performance II
timeFrame: Baseline and 12-16 weeks
measure: Change in functional performance III
timeFrame: Baseline and 12-16 weeks
measure: Change in depressive symptoms
timeFrame: Baseline and 12-16 weeks
measure: State of level of physical activity I
timeFrame: Baseline and 12-16 weeks
measure: State of level of physical activity II
timeFrame: Baseline and 12-16 weeks
measure: Working heart rate
timeFrame: Baseline and 12-16 weeks
measure: Neuromuscular activation
timeFrame: Baseline and 4 weeks
measure: Total repetitions performed
timeFrame: Baseline and 4 weeks
measure: Maximum oxygen consumption
timeFrame: Baseline and 4 weeks
measure: Capillary blood lactate
timeFrame: Baseline and 4 weeks
measure: Rating of perceived exertion
timeFrame: Baseline and 4 weeks
measure: Change in sleep quality
timeFrame: Baseline and 12-16 weeks
Locations:
city: Valencia
country: Spain
facility: Physical Activity and Sport Science Faculty
Study officials:
References: