AgingNCT07914270
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
A study testing Time-Based Aquatic Power Training + Creatine in people with Aging and Supplementation, run by University of Valencia at 1 site in Spain.
Trial summary
This randomized controlled trial will investigate the effects of different aquatic power training dosing strategies and creatine supplementation on functional and multisystem adaptations in community-dwelling older adults. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Aging, Supplementation, Exercise
- What is being tested?
- Time-Based Aquatic Power Training + Creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 15 Oct 2026to 15 May 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60 years at enrollment.
- Community-dwelling and functionally independent in basic activities of daily living.
- Able to ambulate independently, with or without usual assistive devices, and able to safely perform the physical assessments included in the study.
- Clinically stable; participants with chronic diseases must have maintained stable pharmacological treatment for at least three months before the intervention.
- Not currently participating in a structured moderate- or high-intensity strength or power training program or another systematic supervised exercise program.
- Available and willing to participate throughout the 16-week intervention and complete all scheduled assessments.
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- Willing to accept random allocation to any study group and creatine or placebo supplementation when applicable.
- Willing to maintain stable dietary habits throughout the intervention.
- Able and willing to provide written informed consent
Who cannot join
- Uncontrolled cardiovascular, respiratory, metabolic, neurological, or musculoskeletal disease contraindicating exercise or limiting safe participation.
- Unfavorable medical assessment for participation in supervised exercise.
- Uncontrolled hypertension at screening.
- Known kidney disease, renal failure, or clinically relevant impairment of renal function.
- Active liver disease or clinically relevant impairment of liver function.
- Active malignant neoplasm or current cancer treatment.
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- Endocrine or metabolic disorders considered by the research team to substantially interfere with the study's primary outcomes.
- Current use, or use during the previous three months, of creatine or other supplements with potential ergogenic or anabolic effects.
- Pharmacological treatment considered likely to substantially modify the study's primary outcomes.
- Participation during the previous three months in a systematic moderate- or high-intensity strength or power training program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Physical activity and Sport Science Faculty
Valencia, Valencia, 46010
Juan Carlos Colado Sánchez, Chair full professor, (9639) 83470, juan.colado@uv.es
About this study
Official title: Optimization of Aquatic Power Training Dosing Strategies and the Effects of Creatine Supplementation on Functional and Multisystem Adaptations in Older Adults: A Randomized Controlled Trial
This randomized controlled trial will investigate the effects of different aquatic power training dosing strategies and creatine supplementation on functional and multisystem adaptations in community-dwelling older adults.
Participants will be randomly allocated to one of five parallel groups: (1) aquatic power training regulated according to rating of perceived exertion during the first repetition (RPE-1) plus placebo; (2) aquatic power training using a conventional time-based dosing strategy plus placebo; (3) time-based aquatic power training plus creatine supplementation; (4) sedentary control plus placebo; or (5) sedentary control plus creatine supplementation.
Read more
The intervention will last 16 weeks. Aquatic training will be performed three times per week for approximately 60 minutes per session. Participants allocated to creatine supplementation will receive 3 g/day of creatine monohydrate, whereas the corresponding placebo groups will receive a visually indistinguishable placebo following the same supplementation schedule.
The primary outcomes will assess body composition, muscle strength, and functional capacity. Additional outcomes will examine bone health, cardiometabolic health, inflammatory and oxidative stress biomarkers, immune function, neurobiological and cognitive function, quality of life, sleep quality, psychological status, fatigue, and affective state.
Assessments will be performed before and after the 16-week intervention.
Read the detailed description
Participants will be randomly allocated to one of five parallel groups and will complete a 16-week intervention period. The study is designed to evaluate two complementary research questions: (1) whether an aquatic power training program regulated using rating of perceived exertion during the first repetition (RPE-1) produces different adaptations compared with a conventional time-based aquatic power training strategy; and (2) whether daily creatine supplementation enhances the adaptations associated with aquatic power training and/or modifies outcomes in sedentary older adults.
Aquatic Power Training
Participants allocated to either aquatic training condition will complete a 16-week supervised aquatic power training program consisting of three sessions per week, with each session lasting approximately 60 minutes.
The exercise program will focus on the development of muscular power using aquatic exercise. The two training conditions will follow the same overall intervention period and training frequency but will differ in the strategy used to regulate exercise dosage.
In the RPE-1 aquatic power training condition, exercise dosage will be regulated according to the participant's rating of perceived exertion during the first repetition (RPE-1). This strategy will be used to individualize and regulate the exercise stimulus during the training program.
In the time-based aquatic power training condition, exercise dosage will be prescribed using a conventional time-based strategy. Participants will therefore perform the aquatic power training according to the predefined temporal prescription rather than using RPE-1 to regulate exercise dosage.
Aquatic training sessions will be conducted under supervision at the Piscina Cubierta de Benimàmet (Fundación Deportiva Municipal, Valencia, Spain).
Creatine and Placebo Supplementation
Participants assigned to creatine supplementation will receive 3 g/day of creatine monohydrate throughout the 16-week intervention. Supplementation will be taken daily, including non-training days, and no loading phase will be used.
Participants assigned to placebo supplementation will receive a visually indistinguishable placebo following the same daily supplementation schedule.
Creatine and placebo supplementation will be administered under double-blind conditions. Neither participants nor investigators responsible for supplementation administration will know the supplementation allocation until completion of the study.
Study Groups
Participants will be randomly allocated to one of the following five groups:
- RPE-1 Aquatic Power Training + Placebo: 16 weeks of aquatic power training, three sessions per week, with exercise dosage regulated according to RPE-1, combined with daily placebo supplementation.
- Time-Based Aquatic Power Training + Placebo: 16 weeks of aquatic power training, three sessions per week, using a conventional time-based dosing strategy, combined with daily placebo supplementation.
- Time-Based Aquatic Power Training + Creatine: 16 weeks of aquatic power training, three sessions per week, using the conventional time-based dosing strategy, combined with 3 g/day of creatine monohydrate.
- Sedentary Control + Placebo: Participants will not participate in the aquatic power training intervention and will receive placebo supplementation daily throughout the 16-week study period.
- Sedentary Control + Creatine: Participants will not participate in the aquatic power training intervention and will receive 3 g/day of creatine monohydrate throughout the 16-week study period.
Participants allocated to the sedentary control conditions will be instructed to maintain their usual lifestyle during the intervention period and not to initiate a structured moderate- or high-intensity strength or power training program.
Assessment Schedule
Outcome assessments will be performed before the intervention and immediately after completion of the 16-week intervention. Assessments will include body composition, muscle strength, functional capacity, bone metabolism, cardiometabolic health, inflammatory and oxidative stress biomarkers, immune function, neurobiological and cognitive function, quality of life, sleep quality, psychological status, fatigue, affective state, and clinical safety measures.
Questionnaires and cognitive assessments will be administered in person and distributed across two assessment sessions at each evaluation period to reduce participant fatigue.
Because of the nature of the exercise intervention, participants and personnel supervising the training cannot be blinded to the aquatic power training dosing strategy. However, outcome assessors and investigators responsible for statistical analyses will remain blinded to group allocation.
- Conditions
- Aging, Supplementation, Exercise
- Being tested
- RPE-1 Aquatic Power Training-Placebo, Time-Based Aquatic Power Training-Placebo, Time-Based Aquatic Power Training + Creatine, Sedentary Control + Placebo, Sedentary Control + Creatine
- Keywords
- older adults, Nutritional Supplement, Aquatic training, Power training, Healthy aging, Non-Pharmacological intervention, Randomized controlled trial
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPE-1 Aquatic Power Training-PlaceboOther
Participants will complete a 16-week supervised aquatic power training program, consisting of three sessions per week, with each session lasting approximately 60 minutes. Exercises will be performed at maximal intended movement velocity.
For each exercise, participants will perform 4 sets of 8 repetitions. Exercise intensity will be regulated using ratings of perceived exertion (RPE) obtained during the set. During the first repetition (RPE-1), the target RPE will be 4 for the active muscles or 3 for the overall body. By the last repetition of the set, the target RPE will be 6 for the active muscles or 5 for the overall body.
Participants will perform active recovery for 120 seconds between sets and 90 seconds between exercises.
This RPE-based dosing strategy will be used to individualize the aquatic power training stimulus according to each participant's perceived exertion while maintaining maximal intended movement velocity.
Time-Based Aquatic Power Training-PlaceboOther
Participants will complete a 16-week supervised aquatic power training program, consisting of three sessions per week, with each session lasting approximately 60 minutes. Exercises will be performed at maximal intended movement velocity.
The training structure will follow the same general protocol as the RPE-1 aquatic power training condition. However, instead of prescribing exercise volume according to a fixed number of repetitions regulated by RPE-1, participants will perform each exercise for an execution time equivalent to that required to complete the RPE-1 protocol.
Participants will be instructed to perform the exercises at maximal intended movement velocity throughout the prescribed execution period. The maximu
Participants will receive a placebo visually indistinguishable from the creatine supplement. The placebo will be administered daily throughout the 16-week intervention, including non-training days, following the same supplementation schedule as the creatine condition.
Time-Based Aquatic Power Training + CreatineDietary supplement
Participants will complete a 16-week supervised aquatic power training program, consisting of three sessions per week, with each session lasting approximately 60 minutes. Exercises will be performed at maximal intended movement velocity.
The training structure will follow the same general protocol as the RPE-1 aquatic power training condition. However, instead of prescribing exercise volume according to a fixed number of repetitions regulated by RPE-1, participants will perform each exercise for an execution time equivalent to that required to complete the RPE-1 protocol.
Participants will be instructed to perform the exercises at maximal intended movement velocity throughout the prescribed execution period. The maxi
Participants will additionally receive 3 g/day of creatine monohydrate throughout the 16-week intervention. Participants will receive 3 g/day of creatine monohydrate for 16 weeks. Creatine will be administered daily, including non-training days, without a loading phase.
Sedentary Control + PlaceboDietary supplement
Participants allocated to this group will not participate in the aquatic power training intervention and will receive placebo supplementation daily throughout the 16-week study period. Participants will be instructed to maintain their usual lifestyle and habitual physical activity and not to initiate a structured moderate- or high-intensity strength or power training program during the intervention period. Participants will receive a placebo visually indistinguishable from the creatine supplement. The placebo will be administered daily throughout the 16-week intervention following the same supplementation schedule as the creatine condition.
Sedentary Control + CreatineDietary supplement
Participants allocated to this group will not participate in the aquatic power training intervention and will receive 3 g/day of creatine monohydrate throughout the 16-week study period. Participants will be instructed to maintain their usual lifestyle and habitual physical activity and not to initiate a structured moderate- or high-intensity strength or power training program during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - RPE-1 Aquatic Power Training + Placebo | Experimental | Participants will complete a 16-week aquatic power training program, three sessions per week, with each session lasting approximately 60 minutes. Training intensity will be regulated according to the participant's rating of perceived exertion during the first repetition (RPE-1). Participants will receive placebo supplementation daily throughout the 16-week intervention. Receives: Other: RPE-1 Aquatic Power Training-Placebo |
| Arm 2 - Time-Based Aquatic Power Training + Placebo | Active comparator | Participants will complete a 16-week aquatic power training program, three sessions per week, with each session lasting approximately 60 minutes. Exercise dosing will follow a conventional strategy based on work duration. Participants will receive placebo supplementation daily throughout the intervention. Receives: Other: Time-Based Aquatic Power Training-Placebo |
| Arm 3 - Time-Based Aquatic Power Training + Creatine | Active comparator | Participants will complete the same 16-week time-based aquatic power training program and will receive 3 g/day of creatine monohydrate throughout the intervention, including non-training days. Receives: Dietary Supplement: Time-Based Aquatic Power Training + Creatine |
| Arm 4 - Sedentary Control + Placebo | Placebo comparator | Participants allocated to the sedentary control group will not participate in the aquatic power training program and will receive placebo supplementation daily throughout the 16-week intervention. Receives: Dietary Supplement: Sedentary Control + Placebo |
| Arm 5 - Sedentary Control + Creatine | Experimental | Participants allocated to the sedentary control group will not participate in the aquatic power training program and will receive 3 g/day of creatine monohydrate throughout the 16-week intervention. Receives: Dietary Supplement: Sedentary Control + Creatine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Composition via Dual-Energy X-ray Absorptiometry (DXA)
Whole body and segmental composition will be assessed through Dual-Energy X-ray Absorptiometry (DXA). Parameters analyzed will be: total and regional fat mass and lean mass and % of fat mass.
Measured: Pre and post-intervention of 16 weeks
Change in handgrip strength
Handgrip strength (Kg) will be assessed using hand-held dynamometry. Higher values indicate greater muscle strength
Measured: Pre and post-intervention of 16 weeks
Change in lower limb Isokinetic muscle strength
knee flexo-extension muscle strength will be assessed using an isokinetic dynamometer (Biodex®) at an angular velocity of 180°/s. Peak torque will be recorded in Newton-meters (Nm), with higher values indicating greater strength
Measured: Pre and post-intervention of 16 weeks
Change in upper limb Isokinetic muscle Strength
Elbow flexo-extension muscle strength will be assessed using an isokinetic dynamometer (Biodex®) at an angular velocity of 180°/s. Peak torque will be recorded in Newton-meters (Nm), with higher values indicating greater strength
Measured: Pre and post-intervention of 16 weeks
Change in functional mobility and agility performance
Functional mobility and agility will be assessed using the Timed Up and Go Test. The time required to stand from a chair, walk the standardized distance, turn, return, and sit down will be recorded in seconds. Lower values indicate better functional performance.
Measured: Pre and post-intervention of 16 weeks
Change in lower body functional performance
Lower-body functional capacity (resistance strength) will be assessed using the 30-Second Chair Stand Test. The number of complete sit-to-stand repetitions performed within 30 seconds will be recorded. Higher values indicate better functional performance.
Measured: Pre and post-intervention of 16 weeks
Change in aerobic performance
Functional aerobic capacity will be assessed using the 6-Minute Walk Test. The total distance walked during six minutes will be recorded in meters. Higher values indicate better functional capacity.
Measured: Pre and post-intervention of 16 weeks
Secondary outcomes (26)
Change in bone health (bone formation)
Serum procollagen type I N-terminal propeptide (P1NP) will be measured as a marker of bone formation.
Measured: Pre and post-intervention of 16 weeks
Change in bone health (bone resorption)
Serum C-terminal telopeptide of type I collagen (β-CTX) will be measured as a marker of bone resorption
Measured: Pre and post-intervention of 16 weeks
Change in cardiometabolic health (systolic blood pressure)
Resting systolic blood pressure will be assessed and expressed in millimeters of mercury (mmHg), with lower values generally indicating lower cardiovascular risk.
Measured: Pre and post-intervention of 16 weeks
Change in cardiometabolic health (diastolic blood pressure)
Resting diastolic blood pressure will be assessed and expressed in millimeters of mercury (mmHg), with lower values generally indicating lower cardiovascular risk.
Measured: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (total cholesterol)
Total cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (HDL cholesterol)
HDL cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (LDL cholesterol)
LDL cholesterol levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (Triglycerides)
Triglycerides levels will be collected through a blood sample in the morning in a fasted state to assess metabolic state.
Measured: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (fasting plasma glucose)
Fasting plasma glucose concentration will be measured from blood samples collected after an overnight fasting period to assess changes in glucose homeostasis and metabolic state
Measured: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (GLP-1 Concentration)
Circulating glucagon-like peptide-1 (GLP-1) concentration will be measured from blood samples to assess changes in this gut-derived metabolic hormone involved in glucose regulation
Measured: Pre and post-intervention of 16 weeks
Change in inflammation biomarkers (Interleukin-6 Concentration)
Circulating interleukin-6 (IL-6) concentration will be measured from blood samples as a biomarker of systemic low-grade inflammation.
Measured: Pre and post-intervention of 16 weeks
Change in inflammation biomarkers (Tumor Necrosis Factor-Alpha Concentration)
Circulating tumor necrosis factor-alpha (TNF-α) will be measured from blood samples as a biomarker of systemic low-grade inflammation.
Measured: Pre and post-intervention of 16 weeks
Change in Oxidative stress biomarkers (F2-Isoprostane Concentration)
F2-isoprostanes will be measured from blood samples as biomarkers of oxidative stress and lipid peroxidation.
Measured: Pre and post-intervention of 16 weeks
Change in Oxidative stress biomarkers (Glutathione Peroxidase Activity)
Glutathione peroxidase (GPx) activity will be measured from blood samples as a marker of antioxidant defense.
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Total Leukocyte Count)
Total circulating leukocyte count will be measured from peripheral blood samples to assess changes in overall immune cell status
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Neutrophil Count)
Circulating neutrophil count will be measured from peripheral blood samples to assess changes in the neutrophil component of the immune response
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Lymphocyte Count)
Circulating lymphocyte count will be measured from peripheral blood samples to assess changes in the lymphocyte component of immune function
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Monocyte Count)
Circulating monocyte count will be measured from peripheral blood samples to assess changes in this component of the innate immune system
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Eosinophil Count)
Circulating eosinophil count will be measured from peripheral blood samples to assess changes in this leukocyte population
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Basophil Count)
Circulating basophil count will be measured from peripheral blood samples to assess changes in this leukocyte population
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Platelet Count)
Circulating platelet count will be measured from peripheral blood samples to assess changes in platelet levels
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Neutrophil-to-Lymphocyte Ratio)
The neutrophil-to-lymphocyte ratio (NLR) will be calculated by dividing the absolute neutrophil count by the absolute lymphocyte count. NLR will be used as an integrated hematological marker of systemic inflammatory and immune status.
Measured: Pre and post-intervention of 16 weeks
Change in Immune system (Systemic Immune-Inflammation Index )
The Systemic Immune-Inflammation Index (SII) will be calculated from peripheral blood platelet, neutrophil, and lymphocyte counts as an integrated marker of systemic immune-inflammatory status.
Measured: Pre and post-intervention of 16 weeks
Change in Neurobiological function (Brain-Derived Neurotrophic Factor concentration)
Circulating brain-derived neurotrophic factor (BDNF) concentration will be measured from blood samples to assess changes in a neurotrophic factor involved in neuronal function and neuroplasticity .
Measured: Pre and post-intervention of 16 weeks
Change in Cognitive function (Trail Making Test Part A Completion Time)
Cognitive performance will be assessed using the Trail Making Test Part A (TMT-A), which primarily evaluates visual attention, processing speed, and visuomotor tracking. Participants will be instructed to connect numbered targets sequentially as quickly and accurately as possible. Completion time will be recorded in seconds, with lower completion times indicating better performance.
Measured: Pre and post-intervention of 16 weeks
Change in Cognitive function (Trail Making Test Part B Completion Time)
Executive and attentional performance will be assessed using the Trail Making Test Part B (TMT-B), which requires participants to alternate sequentially between numbered and lettered targets. The test primarily assesses cognitive flexibility, set-shifting, divided attention, and executive function. Completion time will be recorded in seconds, with lower completion times indicating better performance.
Measured: Pre and post-intervention of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start15 Oct 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- CIAICO/2023/056 Project (Generalitat Valenciana AICO Grants), Generalitat Valenciana
- Responsible party
- Principal investigator, Juan C. Colado, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914270
- Sponsor's protocol ID
- 2026-FIS-4574602
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Aquatic Power Training Dosing Strategies and the Effects of Creatine Supplementation on Functional and Multisystem Adaptations in Older Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07914270
- Acronym / sponsor ID
- 2026-FIS-4574602
- Conditions
- Aging, Supplementation, Exercise
- Keywords
- older adults, Nutritional Supplement, Aquatic training, Power training, Healthy aging, Non-Pharmacological intervention, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- CIAICO/2023/056 Project (Generalitat Valenciana AICO Grants), Generalitat Valenciana
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
This randomized controlled trial will investigate the effects of different aquatic power training dosing strategies and creatine supplementation on functional and multisystem adaptations in community-dwelling older adults.
Participants will be randomly allocated to one of five parallel groups: (1) aquatic power training regulated according to rating of perceived exertion during the first repetition (RPE-1) plus placebo; (2) aquatic power training using a conventional time-based dosing strategy plus placebo; (3) time-based aquatic power training plus creatine supplementation; (4) sedentary control plus placebo; or (5) sedentary control plus creatine supplementation.
The intervention will last 16 weeks. Aquatic training will be performed three times per week for approximately 60 minutes per session. Participants allocated to creatine supplementation will receive 3 g/day of creatine monohydrate, whereas the corresponding placebo groups will receive a visually indistinguishable placebo following the same supplementation schedule.
The primary outcomes will assess body composition, muscle strength, and functional capacity. Additional outcomes will examine bone health, cardiometabolic health, inflammatory and oxidative stress biomarkers, immune function, neurobiological and cognitive function, quality of life, sleep quality, psychological status, fatigue, and affective state.
Assessments will be performed before and after the 16-week intervention.
Detailed description
Participants will be randomly allocated to one of five parallel groups and will complete a 16-week intervention period. The study is designed to evaluate two complementary research questions: (1) whether an aquatic power training program regulated using rating of perceived exertion during the first repetition (RPE-1) produces different adaptations compared with a conventional time-based aquatic power training strategy; and (2) whether daily creatine supplementation enhances the adaptations associated with aquatic power training and/or modifies outcomes in sedentary older adults.
Aquatic Power Training
Participants allocated to either aquatic training condition will complete a 16-week supervised aquatic power training program consisting of three sessions per week, with each session lasting approximately 60 minutes.
The exercise program will focus on the development of muscular power using aquatic exercise. The two training conditions will follow the same overall intervention period and training frequency but will differ in the strategy used to regulate exercise dosage.
In the RPE-1 aquatic power training condition, exercise dosage will be regulated according to the participant's rating of perceived exertion during the first repetition (RPE-1). This strategy will be used to individualize and regulate the exercise stimulus during the training program.
In the time-based aquatic power training condition, exercise dosage will be prescribed using a conventional time-based strategy. Participants will therefore perform the aquatic power training according to the predefined temporal prescription rather than using RPE-1 to regulate exercise dosage.
Aquatic training sessions will be conducted under supervision at the Piscina Cubierta de Benimàmet (Fundación Deportiva Municipal, Valencia, Spain).
Creatine and Placebo Supplementation
Participants assigned to creatine supplementation will receive 3 g/day of creatine monohydrate throughout the 16-week intervention. Supplementation will be taken daily, including non-training days, and no loading phase will be used.
Participants assigned to placebo supplementation will receive a visually indistinguishable placebo following the same daily supplementation schedule.
Creatine and placebo supplementation will be administered under double-blind conditions. Neither participants nor investigators responsible for supplementation administration will know the supplementation allocation until completion of the study.
Study Groups
Participants will be randomly allocated to one of the following five groups:
- RPE-1 Aquatic Power Training + Placebo: 16 weeks of aquatic power training, three sessions per week, with exercise dosage regulated according to RPE-1, combined with daily placebo supplementation.
- Time-Based Aquatic Power Training + Placebo: 16 weeks of aquatic power training, three sessions per week, using a conventional time-based dosing strategy, combined with daily placebo supplementation.
- Time-Based Aquatic Power Training + Creatine: 16 weeks of aquatic power training, three sessions per week, using the conventional time-based dosing strategy, combined with 3 g/day of creatine monohydrate.
- Sedentary Control + Placebo: Participants will not participate in the aquatic power training intervention and will receive placebo supplementation daily throughout the 16-week study period.
- Sedentary Control + Creatine: Participants will not participate in the aquatic power training intervention and will receive 3 g/day of creatine monohydrate throughout the 16-week study period.
Participants allocated to the sedentary control conditions will be instructed to maintain their usual lifestyle during the intervention period and not to initiate a structured moderate- or high-intensity strength or power training program.
Assessment Schedule
Outcome assessments will be performed before the intervention and immediately after completion of the 16-week intervention. Assessments will include body composition, muscle strength, functional capacity, bone metabolism, cardiometabolic health, inflammatory and oxidative stress biomarkers, immune function, neurobiological and cognitive function, quality of life, sleep quality, psychological status, fatigue, affective state, and clinical safety measures.
Questionnaires and cognitive assessments will be administered in person and distributed across two assessment sessions at each evaluation period to reduce participant fatigue.
Because of the nature of the exercise intervention, participants and personnel supervising the training cannot be blinded to the aquatic power training dosing strategy. However, outcome assessors and investigators responsible for statistical analyses will remain blinded to group allocation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - RPE-1 Aquatic Power Training + Placebo | Experimental | Other: RPE-1 Aquatic Power Training-PlaceboParticipants will complete a 16-week aquatic power training program, three sessions per week, with each session lasting approximately 60 minutes. Training intensity will be regulated according to the participant's rating of perceived exertion during the first repetition (RPE-1). Participants will receive placebo supplementation daily throughout the 16-week intervention. |
| Arm 2 - Time-Based Aquatic Power Training + Placebo | Active comparator | Other: Time-Based Aquatic Power Training-PlaceboParticipants will complete a 16-week aquatic power training program, three sessions per week, with each session lasting approximately 60 minutes. Exercise dosing will follow a conventional strategy based on work duration. Participants will receive placebo supplementation daily throughout the intervention. |
| Arm 3 - Time-Based Aquatic Power Training + Creatine | Active comparator | Dietary Supplement: Time-Based Aquatic Power Training + CreatineParticipants will complete the same 16-week time-based aquatic power training program and will receive 3 g/day of creatine monohydrate throughout the intervention, including non-training days. |
| Arm 4 - Sedentary Control + Placebo | Placebo comparator | Dietary Supplement: Sedentary Control + PlaceboParticipants allocated to the sedentary control group will not participate in the aquatic power training program and will receive placebo supplementation daily throughout the 16-week intervention. |
| Arm 5 - Sedentary Control + Creatine | Experimental | Dietary Supplement: Sedentary Control + CreatineParticipants allocated to the sedentary control group will not participate in the aquatic power training program and will receive 3 g/day of creatine monohydrate throughout the 16-week intervention. |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥60 years at enrollment.
- Community-dwelling and functionally independent in basic activities of daily living.
- Able to ambulate independently, with or without usual assistive devices, and able to safely perform the physical assessments included in the study.
- Clinically stable; participants with chronic diseases must have maintained stable pharmacological treatment for at least three months before the intervention.
- Not currently participating in a structured moderate- or high-intensity strength or power training program or another systematic supervised exercise program.
Key exclusion criteria (10 listed)
- Uncontrolled cardiovascular, respiratory, metabolic, neurological, or musculoskeletal disease contraindicating exercise or limiting safe participation.
- Unfavorable medical assessment for participation in supervised exercise.
- Uncontrolled hypertension at screening.
- Known kidney disease, renal failure, or clinically relevant impairment of renal function.
- Active liver disease or clinically relevant impairment of liver function.
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 |
|---|---|---|
| RPE-1 Aquatic Power Training-PlaceboParticipants will complete a 16-week supervised aquatic power training program, consisting of three sessions per week, with each session lasting approximately 60 minutes. Exercises will be performed at maximal intended movement velocity. For each exercise, participants will perform 4 sets of 8 repetitions. Exercise intensity will be regulated using ratings of perceived exertion (RPE) obtained during the set. During the first repetition (RPE-1), the target RPE will be 4 for the active muscles or 3 for the overall body. By the last repetition of the set, the target RPE will be 6 for the active muscles or 5 for the overall body. Participants will perform active recovery for 120 seconds between sets and 90 seconds between exercises. This RPE-based dosing strategy will be used to individualize the aquatic power training stimulus according to each participant's perceived exertion while maintaining maximal intended movement velocity. | Other | Arm 1 - RPE-1 Aquatic Power Training + Placebo |
| Time-Based Aquatic Power Training-PlaceboParticipants will complete a 16-week supervised aquatic power training program, consisting of three sessions per week, with each session lasting approximately 60 minutes. Exercises will be performed at maximal intended movement velocity. The training structure will follow the same general protocol as the RPE-1 aquatic power training condition. However, instead of prescribing exercise volume according to a fixed number of repetitions regulated by RPE-1, participants will perform each exercise for an execution time equivalent to that required to complete the RPE-1 protocol. Participants will be instructed to perform the exercises at maximal intended movement velocity throughout the prescribed execution period. The maximu Participants will receive a placebo visually indistinguishable from the creatine supplement. The placebo will be administered daily throughout the 16-week intervention, including non-training days, following the same supplementation schedule as the creatine condition. | Other | Arm 2 - Time-Based Aquatic Power Training + Placebo |
| Time-Based Aquatic Power Training + CreatineParticipants will complete a 16-week supervised aquatic power training program, consisting of three sessions per week, with each session lasting approximately 60 minutes. Exercises will be performed at maximal intended movement velocity. The training structure will follow the same general protocol as the RPE-1 aquatic power training condition. However, instead of prescribing exercise volume according to a fixed number of repetitions regulated by RPE-1, participants will perform each exercise for an execution time equivalent to that required to complete the RPE-1 protocol. Participants will be instructed to perform the exercises at maximal intended movement velocity throughout the prescribed execution period. The maxi Participants will additionally receive 3 g/day of creatine monohydrate throughout the 16-week intervention. Participants will receive 3 g/day of creatine monohydrate for 16 weeks. Creatine will be administered daily, including non-training days, without a loading phase. | Dietary supplement | Arm 3 - Time-Based Aquatic Power Training + Creatine |
| Sedentary Control + PlaceboParticipants allocated to this group will not participate in the aquatic power training intervention and will receive placebo supplementation daily throughout the 16-week study period. Participants will be instructed to maintain their usual lifestyle and habitual physical activity and not to initiate a structured moderate- or high-intensity strength or power training program during the intervention period. Participants will receive a placebo visually indistinguishable from the creatine supplement. The placebo will be administered daily throughout the 16-week intervention following the same supplementation schedule as the creatine condition. | Dietary supplement | Arm 4 - Sedentary Control + Placebo |
| Sedentary Control + CreatineParticipants allocated to this group will not participate in the aquatic power training intervention and will receive 3 g/day of creatine monohydrate throughout the 16-week study period. Participants will be instructed to maintain their usual lifestyle and habitual physical activity and not to initiate a structured moderate- or high-intensity strength or power training program during the intervention period. | Dietary supplement | Arm 5 - Sedentary Control + Creatine |
Primary outcome
Change in Body Composition via Dual-Energy X-ray Absorptiometry (DXA)
Time frame: Pre and post-intervention of 16 weeks
Whole body and segmental composition will be assessed through Dual-Energy X-ray Absorptiometry (DXA). Parameters analyzed will be: total and regional fat mass and lean mass and % of fat mass.
Change in handgrip strength
Time frame: Pre and post-intervention of 16 weeks
Handgrip strength (Kg) will be assessed using hand-held dynamometry. Higher values indicate greater muscle strength
Change in lower limb Isokinetic muscle strength
Time frame: Pre and post-intervention of 16 weeks
knee flexo-extension muscle strength will be assessed using an isokinetic dynamometer (Biodex®) at an angular velocity of 180°/s. Peak torque will be recorded in Newton-meters (Nm), with higher values indicating greater strength
Change in upper limb Isokinetic muscle Strength
Time frame: Pre and post-intervention of 16 weeks
Elbow flexo-extension muscle strength will be assessed using an isokinetic dynamometer (Biodex®) at an angular velocity of 180°/s. Peak torque will be recorded in Newton-meters (Nm), with higher values indicating greater strength
Change in functional mobility and agility performance
Time frame: Pre and post-intervention of 16 weeks
Functional mobility and agility will be assessed using the Timed Up and Go Test. The time required to stand from a chair, walk the standardized distance, turn, return, and sit down will be recorded in seconds. Lower values indicate better functional performance.
Change in lower body functional performance
Time frame: Pre and post-intervention of 16 weeks
Lower-body functional capacity (resistance strength) will be assessed using the 30-Second Chair Stand Test. The number of complete sit-to-stand repetitions performed within 30 seconds will be recorded. Higher values indicate better functional performance.
Change in aerobic performance
Time frame: Pre and post-intervention of 16 weeks
Functional aerobic capacity will be assessed using the 6-Minute Walk Test. The total distance walked during six minutes will be recorded in meters. Higher values indicate better functional capacity.
26 secondary outcomes
Change in bone health (bone formation)
Time frame: Pre and post-intervention of 16 weeks
Change in bone health (bone resorption)
Time frame: Pre and post-intervention of 16 weeks
Change in cardiometabolic health (systolic blood pressure)
Time frame: Pre and post-intervention of 16 weeks
Change in cardiometabolic health (diastolic blood pressure)
Time frame: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (total cholesterol)
Time frame: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (HDL cholesterol)
Time frame: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (LDL cholesterol)
Time frame: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (Triglycerides)
Time frame: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (fasting plasma glucose)
Time frame: Pre and post-intervention of 16 weeks
Change in metabolic biomarkers (GLP-1 Concentration)
Time frame: Pre and post-intervention of 16 weeks
Change in inflammation biomarkers (Interleukin-6 Concentration)
Time frame: Pre and post-intervention of 16 weeks
Change in inflammation biomarkers (Tumor Necrosis Factor-Alpha Concentration)
Time frame: Pre and post-intervention of 16 weeks
Change in Oxidative stress biomarkers (F2-Isoprostane Concentration)
Time frame: Pre and post-intervention of 16 weeks
Change in Oxidative stress biomarkers (Glutathione Peroxidase Activity)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Total Leukocyte Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Neutrophil Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Lymphocyte Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Monocyte Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Eosinophil Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Basophil Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Platelet Count)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Neutrophil-to-Lymphocyte Ratio)
Time frame: Pre and post-intervention of 16 weeks
Change in Immune system (Systemic Immune-Inflammation Index )
Time frame: Pre and post-intervention of 16 weeks
Change in Neurobiological function (Brain-Derived Neurotrophic Factor concentration)
Time frame: Pre and post-intervention of 16 weeks
Change in Cognitive function (Trail Making Test Part A Completion Time)
Time frame: Pre and post-intervention of 16 weeks
Change in Cognitive function (Trail Making Test Part B Completion Time)
Time frame: Pre and post-intervention of 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 3 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-Based Aquatic Power Training + Creatine in people with Aging and Supplementation, 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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Nov 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?
Contact Juan Carlos Colado Sánchez, Chair full professor ((9639) 83470, juan.colado@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Composition via Dual-Energy X-ray Absorptiometry (DXA) (time frame: Pre and post-intervention of 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.