NCT06620666

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jan 2024Jul 2027

Study Start

First participant enrolled

January 24, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

March 30, 2025

Status Verified

September 1, 2024

Enrollment Period

3.5 years

First QC Date

September 18, 2024

Last Update Submit

March 25, 2025

Conditions

Keywords

AgingDose-responseVariable resistance trainingExercise modalitiesExercise intensitiesOxidative stressBone healthNeuromuscular physiologyPhysical activityCellular agingTraining devicesDietary supplementsStrength trainingCognitive functionBody compositionMetabolic profileInflammatory profileImmunological profilePhysical performanceDNA damage

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (12)

  • Change in blood pressure

    Baseline and 12-16 weeks

  • Change in renal and hepatic profile I

    Baseline and 12-16 weeks

  • Change in renal and hepatic profile II

    Baseline and 12-16 weeks

  • Change in lipid profile

    Baseline and 12-16 weeks

  • Change in metabolic profile I

    Baseline and 12-16 weeks

  • +7 more secondary outcomes

Other Outcomes (40)

  • Change in isokinetic muscle strength

    Baseline and 12-16 weeks

  • Change in maximal muscle hand grip strength

    Baseline and 12-16 weeks

  • Change in fracture risk

    Baseline and 12-16 weeks

  • +37 more other outcomes

Study Arms (12)

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)

Interventions

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 + Dietary supplement I (WPowDSI)

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.

Water-based power resistance training + Placebo (WPowPl)

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 + Dietary supplement I (EBPowDSI)

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 power resistance training + Placebo (EBPowPl)

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 + Dietary supplement II (EBEccDSII)

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 eccentric resistance training + Placebo (EBEccPl)

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 + Dietary supplement II (EBMaxDSII)

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.

Elastic band-based maximum strength resistance training + Placebo (EBMaxPl)
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 + 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 supplementation, participants were randomly assigned to receive their daily dose.

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.

Control + Dietary supplement II (CDSII)

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.

Aerobic training + Placebo (AerPl)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Activity and Sport Science Faculty

Valencia, Valencia, 46020, Spain

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
For masking the participants, the investigators will not inform participants of what group they will be in. For outcome assessor, data collectors and data analysts independent people will be use, and if this is not possible, a random code will be created for each participant so that it is not possible to identify which group belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Chaired Full Professor of Physical Education and Sports

Study Record Dates

First Submitted

September 18, 2024

First Posted

October 1, 2024

Study Start

January 24, 2024

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Last Updated

March 30, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations