An interventional study of RPE-1 Aquatic Power Training-Placebo and Time-Based Aquatic Power Training-Placebo in Aging, Supplementation and Exercise, sponsored by University of Valencia. Recruiting at 1 site in Spain. Open to participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Valencia · Not applicable, Interventional, and Prevention
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.
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:
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.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Valencia is the lead sponsor of 357 studies on the registry; 75 are open to participants now.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: RPE-1 Aquatic Power Training-Placebo
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.
Other: Time-Based Aquatic Power Training-Placebo
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.
Dietary Supplement: Time-Based Aquatic Power Training + Creatine
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.
Dietary Supplement: Sedentary Control + Placebo
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.
Dietary Supplement: Sedentary Control + Creatine
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.
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.
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.
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.
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.
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre and post-intervention of 16 weeks
Change in bone health (bone formation)
Serum procollagen type I N-terminal propeptide (P1NP) will be measured as a marker of bone formation.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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.
Time frame: Pre and post-intervention of 16 weeks
Change in WHOQOL-OLD Score
Quality of life in older adults will be assessed using the World Health Organization Quality of Life-OLD (WHOQOL-OLD) questionnaire, which evaluates relevant dimensions of quality of life specifically related to older populations. Changes in questionnaire scores will be used to assess the effect on perceived quality of life.
Time frame: Pre and post-intervention of 16 weeks
Change in Health-Related Quality of Life Assessed by the EQ-5D-5L
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The instrument evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Changes in EQ-5D-5L health status will be used to assess the effect on perceived health-related quality of life.
Time frame: Pre and post-intervention of 16 weeks
Change in Pittsburgh Sleep Quality Index Score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates different aspects of sleep over the preceding month. Changes in the global PSQI score will be used to assess sleep quality, with higher scores indicating poorer sleep quality
Time frame: Pre and post-intervention of 16 weeks
Change in Depressive symptoms
Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Changes in the total score will be used to assess depressive symptom severity, with higher scores indicating greater severity of depressive symptoms.
Time frame: Pre and post-intervention of 16 weeks
Change in Fatigue
Fatigue will be assessed using the 10-item Fatigue Assessment Scale (FAS). Each item is rated on a five-point response scale ranging from 1 (never) to 5 (always). Changes in the total FAS score will be used to assess perceived fatigue, with higher scores indicating greater fatigue.
Time frame: Pre and post-intervention of 16 weeks
Change in Affective State
Positive affect will be assessed using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS). The PANAS comprises 20 affect-related items rated on a five-point response scale. Changes in the Positive Affect subscale score will be used to assess changes in positive emotional state, with higher scores indicating greater positive affect.
Time frame: Pre and post-intervention of 16 weeks
Change in Serum Creatinine
Serum creatinine concentration will be assessed as a clinical safety marker related to renal function.
Time frame: Pre and post-intervention of 16 weeks
Change in Alanine Aminotransferase
Serum alanine aminotransferase (ALT) concentration will be assessed as a clinical safety marker related to liver function.
Time frame: Pre and post-intervention of 16 weeks
Change in Aspartate Aminotransferase
Serum aspartate aminotransferase (AST) concentration will be assessed as a clinical safety marker related to liver function.
Time frame: Pre and post-intervention of 16 weeks
Incidence of Adverse Events
Adverse events potentially associated with the aquatic exercise intervention or creatine/placebo supplementation will be recorded and clinically evaluated throughout the intervention period.
Time frame: Throughout the 16-week intervention.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 6 months after the start.
Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 6 months is below that.
Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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