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The Effects of Increased Water Intake on Muscle Function, Physical Performance, and Endocrine Regulation in Low-Drinking Older Adults (HydraAge)

5 november 2026 bijgewerkt door: Rúben Francisco, Polytechnic University of Santarém

The Effects of Increased Water Intake on Muscle Function, Physical Performance, and Endocrine Regulation in Low-Drinking Older Adults: A Randomized Controlled Trial

Population aging represents one of the major demographic transformations of the 21st century. However, increased longevity has not been accompanied by preserved functional independence. Falls are currently the leading cause of injury-related mortality and a major contributor to hospitalization, disability, and institutionalization among older adults. Even subtle deficits in muscle strength, balance, and mobility can significantly increase fall risk, triggering a cycle of functional decline and frailty.

Emerging evidence suggests that hydration status may represent a modifiable determinant of neuromuscular function. Many older adults live in a state of chronically low water intake, a condition associated with subtle yet persistent alterations in endocrine regulation and body water distribution. Total body water is distributed between extracellular and intracellular compartments, the latter being particularly relevant to muscle quality. Observational studies demonstrate that higher intracellular water levels are associated with greater strength, faster gait speed, better overall functional performance, and lower fall risk. In parallel, low water intake is associated with elevated arginine vasopressin (AVP) concentrations, a hormone with systemic effects that may contribute to metabolic stress and potential impairment of muscle function.

Despite water being the most accessible and low-cost health intervention, no randomized controlled trials have examined whether increasing daily water intake can improve fall-related functional performance in older adults with habitual low intake.

The HYDRAGE study aims to address this gap through a randomized controlled trial evaluating the effects of increasing daily water intake in adults aged ≥50 years with habitual intake ≤35 ml/kg/day. Participants will be allocated to either a control group (maintaining habitual intake) or an experimental group (≥45 ml/kg/day) for 7 days. The primary objective is to assess the effect of increased water intake on neuromuscular strength, specifically isokinetic knee extension and handgrip strength, as key determinants of fall risk. Secondary objectives include evaluating fall-related functional performance (SPPB and TUG), endocrine regulation (AVP), hydration biomarkers (urine and saliva osmolality and urine specific gravity, assessed using an osmometer), body water distribution (ECW/ICW ratio and phase angle, assessed by bioelectrical impedance analysis), physical activity levels, and psychological state.

We hypothesize that increasing daily water intake will improve fall-related functional performance, with these effects being partially explained by improvements in intracellular hydration and reductions in AVP-mediated endocrine stress.

By prioritizing clinically meaningful functional outcomes while integrating underlying physiological mechanisms, the project combines translational relevance with mechanistic depth. Because both the intervention and the functional assessments are simple, low-cost, and easily deployable across clinical and community settings, the study presents strong scalability potential as a strategy for fall prevention and healthy aging.

Studie Overzicht

Gedetailleerde beschrijving

Population aging is one of the most significant public health transformations of the 21st century [1]. However, increased longevity has not been accompanied by preserved independence. Falls have emerged as the leading cause of injury-related mortality and a major driver of hospitalization, disability, and institutionalization among older adults [2]. A recent national study [3] revealed that 34.9% of all fall incidents occurred in individuals aged 85 and older. Additionally, the incidence of falls among adults aged 50-60 years was 19%, increasing to 28% in those aged 70 and above [3]. Beyond the immediate trauma, falls often initiate a cascade of functional decline, fear of movement, reduced physical activity, and progressive frailty [4]. At the core of fall susceptibility lies the age-related decline in neuromuscular function, balance control, and lower-limb strength, i.e., biological hallmarks of aging that compromise functional autonomy [5]. In particular, lower-limb muscle strength and power and handgrip strength decline progressively with age and have consistently been associated with increased fall risk [6, 7]. Lower-limb strength is essential to support body weight, maintain postural stability, and recover from perturbations, whereas handgrip strength may function as a protective "second line of defense," enabling older adults to grasp support surfaces and attenuate the impact of a fall. The low levels of physical activity exacerbate the decline typically observed in older adults, further diminishing muscle function and functional independence [5]. Emerging evidence, however, highlights hydration as an overlooked determinant of functionality and muscle performance in the elderly [8]. Paradoxically, despite tightly regulated homeostatic mechanisms, many individuals live in a state of chronic low water intake (LWI) [9]. Older adults are uniquely predisposed to this state due to impaired thirst perception [10], renal changes [11], polypharmacy [12], and mobility restrictions [12]. Importantly, even subtle impairments in neuromuscular function or balance may substantially increase fall risk in this population. Additionally, total body water (TBW) is divided into extracellular water (ECW) and intracellular water (ICW), with ICW being closely tied to muscle quality: older adults with higher ICW, even when lean mass is comparable, exhibit superior strength, functionality, gait speed, and a lower risk of falls [13, 14].

These findings suggest that water distribution is not merely a reflection of health status but a modifiable determinant of neuromuscular integrity and fall susceptibility [13, 14]. Yet, despite water being the most accessible, low-cost, and universally available health intervention, randomized trials examining whether increasing daily water intake can improve functional performance, reduce fall risk, and improve body water distribution in older adults are virtually nonexistent [15]. Beyond structural hydration compartments, endocrine regulation represents an additional pathway linking LWI to functional decline. The state of underhydration is characterized by persistently elevated arginine vasopressin (AVP) concentrations [9]. Although this state maintains TBW and plasma osmolality within narrow ranges [9], it may do so at a physiological cost.

Chronic AVP elevation has been associated with conditions such as kidney stones [16], insulin resistance [16], inflammation [17], mood changes [18], and skeletal muscle atrophy [18], all of which are closely linked to chronic diseases [16]. Specifically, AVP plays a central role in this discussion. Beyond its antidiuretic function, elevated circulating AVP has been shown to promote hyperglycemia, stimulate hepatic gluconeogenesis, and increase plasma glucagon concentration [19]. Individuals with type 2 diabetes consistently exhibit higher plasma AVP concentrations, supporting a plausible mechanistic link between chronic LWI and metabolic dysregulation [19]. In addition, activation of the renin angiotensin-aldosterone system in response to LWI or sustained water loss can impair insulin signaling via elevated aldosterone concentrations [20], while chronic alterations in cellular hydration status may directly affect cellular metabolism in ways that favor insulin resistance [21].

Furthermore, LWI may indirectly influence metabolic health by modulating dietary glycemic load, as water consumption with meals can attenuate postprandial glycemic responses [22]. Thus, it must be concluded that beyond musculoskeletal function, chronic LWI has been consistently associated with systemic metabolic disturbances that may further accelerate functional decline. To date, no trial has examined whether improving hydration could preserve muscle strength and power, improve the balance of water distribution across compartments, enhance physical activity levels, or improve the pathological elevation of AVP in older adults. The HYDRAGE study was therefore designed to address this critical gap.

Studietype

Ingrijpend

Inschrijving (Geschat)

78

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Age ≥50 years.
  2. Habitual low water intake (≤35 ml/kg/day), confirmed through dietary assessment.
  3. Community-dwelling and able to attend study visits at the SPRINT laboratories.
  4. Independent ambulation (without an assistive device).
  5. Stable clinical condition for at least three months before enrollment.
  6. Auto reported adequate cognitive function to provide informed consent and comply with study procedures.
  7. Willingness to maintain habitual physical activity and dietary patterns (except for prescribed water intake modification)

Exclusion Criteria:

  1. Clinically unstable cardiovascular disease.

  2. Clinically unstable renal disease.

  3. Clinically unstable metabolic or endocrine disease.

  4. Clinically unstable type 2 diabetes.

  5. Any medical condition requiring fluid restriction.

  6. Known history of recurrent hyponatremia.

  7. Chronic use of medications known to substantially affect fluid and electrolyte balance, including:- Loop diuretics;

    • Thiazide diuretics;
    • Desmopressin;
    • Sodium-glucose cotransporter-2 (SGLT2) inhibitors.
  8. Cognitive impairment preventing the provision of informed consent.

  9. Musculoskeletal or neurological conditions that preclude participation in physical performance assessments.

  10. Major surgery within the previous six months.

  11. Current alcohol or substance abuse.

  12. Participation in another clinical trial within the previous three months.

  13. Any other condition considered by the investigators to compromise participant safety, study compliance, or interpretation of the study results.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Increased Water Intake

Participants will maintain their habitual total water intake and usual dietary and physical activity patterns throughout the 7-day study period. Participants will not receive the hydration tools or behavioral support provided to the experimental group.

Participants will be assigned at random to either the experimental group (EG) or the control group (CG). Over the 7-day intervention period, the EG will be asked to increase total daily water intake (WI) to at least 45 mL·kg-¹·day-¹, while the CG will continue their usual water consumption, corresponding to ≤35 mL·kg-¹·day-¹. Total WI will account for water obtained from both beverages and food.

Participants allocated to the EG will be instructed to keep their usual dietary habits unchanged during the intervention so that the amount of water derived from food remains comparable to habitual intake. Accordingly, the intervention will involve an increase in fluid consumption only. The additional amount of water required to reach the target of ≥45 mL·kg-¹·day-¹ will be individually determined based on body mass and the estimated contribution of food to total WI. Vimeiro Original natural mineral water will be used as the additional source of fluid.

Geen tussenkomst: No intervention

Participants will maintain their habitual total water intake and usual dietary and physical activity patterns throughout the 7-day study period. No additional water, hydration tools, or behavioral support will be provided. Participants will complete daily food and fluid records to document their habitual intake during the intervention period.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Absolute and Relative Ankle Plantar-Flexion Peak Force
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Absolute peak force (N) and relative peak force (N·kg-¹) during a seated maximal voluntary isometric plantar-flexion contraction of the dominant limb. The highest force value recorded across four trials will be used for analysis.

Day 1 (baseline) and Day 7 (post-intervention)
Rate of Force Development During Isometric Ankle Plantar-Flexion
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Rate of force development (RFD; N·s-¹) during maximal voluntary isometric plantar-flexion of the dominant limb, calculated over consecutive 50-ms intervals from contraction onset: 0-50, 50-100, 100-150, and 150-200 ms.

Day 1 (baseline) and Day 7 (post-intervention)
Rate of Force Development During Dynamic Ankle Plantar-Flexion
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Rate of force development (N·s-¹) during a standing bilateral rapid calf-raise task, calculated as peak force (N) divided by time to peak force (s).

Day 1 (baseline) and Day 7 (post-intervention)
Explosive Isometric Ankle Plantar-Flexion Force
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Explosive force, expressed as the percentage of peak force (%F) attained at 50, 100, 150, and 200 ms following contraction onset during maximal voluntary isometric plantar-flexion of the dominant limb.

Day 1 (baseline) and Day 7 (post-intervention)
Peak Force during the 5 repetition STS
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Peak vertical ground reaction force (N) recorded during the concentric phase of each sit-to-stand repetition. The participant-level summary measure will be defined a priori.

Day 1 (baseline) and Day 7 (post-intervention)
Fatigue Index During the 30-Second Sit-to-Stand Test
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Fatigue index calculated to quantify the decline in performance across successive sit-to-stand repetitions during the 30-s STS. The calculation method will be specified a priori.

Day 1 (baseline) and Day 7 (post-intervention)
Mean Power During the 30-Second Sit-to-Stand Test
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Mean lower-limb muscle power during the 30-s STS, estimated using a previously validated equation.

Day 1 (baseline) and Day 7 (post-intervention)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Complete the First Five Sit-to-Stand Repetitions
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Time (s) required to complete the first five sit-to-stand repetitions during the 30-s STS test, measured from the onset of the first repetition until completion of the fifth repetition. Only participants completing at least five repetitions will be included in this analysis.

Day 1 (baseline) and Day 7 (post-intervention)
Functional Lower-Limb Performance
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Number of completed repetitions during the 30-second sit-to-stand test (30-s STS), performed from a 43-cm armless chair.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Handgrip strength
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Handgrip strength will be assessed using a portable hand dynamometer (Jamar Plus+). Participants will perform three maximal voluntary isometric contractions with each hand alternately. A 60-second rest period will be provided between attempts. The highest recorded value will be used for analysis. The outcome will be expressed as the change in handgrip strength from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Short Physical Performance Battery Score
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Functional performance will be assessed using the Short Physical Performance Battery (SPPB), comprising static balance, 4-meter gait speed, and repeated chair stand tests. The SPPB score will be calculated according to the standardized scoring procedure. The outcome will be expressed as the change in SPPB score from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Timed Up and Go Test Performance
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

The Timed Up and Go (TUG) test will assess functional mobility and fall risk. Participants will stand from a chair, walk 3 meters, turn around a reference point, return to the chair, and sit down. The time required to complete the test will be recorded. The outcome will be expressed as the change in TUG completion time from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Serum Arginine Vasopressin Concentration
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Serum arginine vasopressin (AVP), will be assessed as a biomarker of the physiological regulation of water balance. Venous blood samples will be collected in the morning after an overnight fast. Serum AVP concentration will be determined using a radioimmunoassay (RIA) according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in serum AVP concentration from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Fasting Serum Glucose Concentration
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Fasting serum glucose concentration will be assessed as a biochemical marker of glucose metabolism. Venous blood samples will be collected in the morning following an overnight fast of 8-12 hours. Serum glucose concentration will be determined using the hexokinase-glucose-6-phosphate dehydrogenase enzymatic method according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in fasting serum glucose concentration from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Serum Cortisol Concentration
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Serum basal cortisol concentration will be assessed as an endocrine biomarker. Venous blood samples will be collected in the morning following an overnight fast, with the time of blood collection recorded to account for the circadian variation in cortisol concentrations. Serum cortisol concentration will be determined using a chemiluminescence assay according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in serum cortisol concentration from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Fasting Serum Insulin Concentration
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Fasting serum insulin concentration will be assessed as a biochemical marker of insulin metabolism. Venous blood samples will be collected in the morning following an overnight fast of 8-12 hours. Serum insulin concentration will be determined using a chemiluminescence immunoassay according to the standardized procedures of the clinical laboratory. The outcome will be expressed as the change in fasting serum insulin concentration from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Insulin resistance will be estimated using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), calculated from fasting serum glucose and fasting serum insulin concentrations. HOMA-IR will be calculated as: fasting insulin (μU/mL) × fasting glucose (mmol/L) / 22.5. The outcome will be expressed as the change in HOMA-IR from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in serum osmolality
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Serum, osmolality (mOsm/kg) will be measured using a freezing-point depression osmometer (Mod OSMO1, Advanced Instruments, Canada). All osmolality measurements will be performed in duplicate.

Day 1 (baseline) and Day 7 (post-intervention)
Change in saliva osmolality
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Saliva osmolality (mOsm/kg) will be measured using a freezing-point depression osmometer (Mod OSMO1, Advanced Instruments, Canada). All osmolality measurements will be performed in duplicate. Unstimulated saliva samples will be collected with participants seated comfortably after resting quietly for 2 min, allowing saliva to accumulate passively in the mouth. Participants will then provide approximately 3-4 mL of saliva into Salivette collection tubes or until no additional saliva can be comfortably produced.

Day 1 (baseline) and Day 7 (post-intervention)
Change in urine osmolality
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Urine osmolality (mOsm/kg) will be measured using a freezing-point depression osmometer (Mod OSMO1, Advanced Instruments, Canada). Urine samples will be collected in sterile urine collection cups at the specified assessment time point. Participants will be instructed to provide a midstream urine sample after discarding the initial urine stream. All osmolality measurements will be performed in duplicate.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Urine Specific Gravity
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Urine specific gravity (USG) will be assessed as a urinary marker of hydration status. A urine sample will be collected at the specified assessment time point, and USG will be determined using a digital refractometer (KERN ORM 1CO, KERN & Sohn GmbH, Germany). The outcome will be expressed as the change in urine specific gravity from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Urine Color
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Urine color will be assessed as a subjective urinary marker of hydration status. Urine color will be evaluated from a urine sample collected at the specified assessment time point using a standardized urine color scale. The outcome will be expressed as the change in urine color from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Total Water Intake
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Total water intake (WI), including water obtained from beverages and foods, will be assessed using three-day food diaries. A certified dietitian will provide standardized instructions regarding portion sizes and food and beverage recording. Food Processor Plus® software will be used to estimate daily total water intake. The outcome will be expressed as the change in average daily total water intake from the screening/baseline assessment to the intervention period.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Body Mass Index
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Body mass index (BMI) will be calculated as body mass in kilograms divided by height in meters squared (kg/m²). Body mass and height will be assessed under standardized conditions. The outcome will be expressed as the change in BMI from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Total Body Water
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Total body water (TBW) will be estimated using whole-body and segmental bioelectrical impedance analysis (BIA) using a phase-sensitive single-frequency analyzer (AKERN BIA 101/BIVA PRO; Akern Srl, Florence, Italy). Participants will rest in the supine position for 10 minutes before assessment. The outcome will be expressed as the change in estimated total body water from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Intracellular Water
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Intracellular water (ICW) will be estimated using whole-body and segmental bioelectrical impedance analysis. The outcome will be expressed as the change in estimated intracellular water from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Extracellular Water
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Extracellular water (ECW) will be estimated using whole-body and segmental bioelectrical impedance analysis. The outcome will be expressed as the change in estimated extracellular water from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Extracellular-to-Intracellular Water Ratio
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

The extracellular-to-intracellular water ratio (ECW/ICW) will be calculated from bioelectrical impedance-derived estimates of extracellular and intracellular water. The outcome will be expressed as the change in the ECW/ICW ratio from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Bioelectrical Impedance Phase Angle
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Whole-body and segmental phase angle (PhA) will be obtained from resistance and reactance measurements using a phase-sensitive single-frequency bioelectrical impedance analyzer. The outcome will be expressed as the change in phase angle from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Resistance-to-Height Ratio
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

The resistance-to-height ratio (R/H) will be calculated from raw bioelectrical impedance resistance measurements normalized for participant height. The outcome will be expressed as the change in R/H from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Reactance-to-Height Ratio
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

The reactance-to-height ratio (Xc/H) will be calculated from raw bioelectrical impedance reactance measurements normalized for participant height. The outcome will be expressed as the change in Xc/H from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Impedance-to-Height Ratio
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

The Impedance-to-height ratio (Z/H) will be calculated from raw bioelectrical impedance reactance measurements normalized for participant height. The outcome will be expressed as the change in Z/H from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Perceived Thirst
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Perceived thirst will be assessed using a 10-cm visual analogue scale (VAS). Participants will indicate their subjective level of thirst by placing a mark along the scale according to their perceived sensation. The outcome will be expressed as the change in thirst VAS score from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Profile of Mood States Score
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Psychological state will be assessed using the Profile of Mood States (POMS), a 65-item self-administered questionnaire assessing six mood dimensions: tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, vigor-activity, and confusion-bewilderment. The outcome will be expressed as the change in POMS scores from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)
Change in Health-Related Quality of Life
Tijdsspanne: Day 1 (baseline) and Day 7 (post-intervention)

Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire assesses eight domains of physical and mental health and provides physical and mental component summary scores. The outcome will be expressed as the change in SF-36 scores from baseline to the post-intervention assessment.

Day 1 (baseline) and Day 7 (post-intervention)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Rúben Francisco Francisco, PhD, Sport Physical Activity and Health Research & Innovation Center

Publicaties en nuttige links

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Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

30 april 2027

Studie voltooiing (Geschat)

31 juli 2028

Studieregistratiedata

Eerst ingediend

18 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 oktober 2026

Eerst geplaatst (Werkelijk)

23 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

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Beschrijving IPD-plan

Individual participant data will not be made publicly available because of participant privacy and data protection considerations. The study data will be handled confidentially and access to identifiable information will be restricted to authorized members of the research team. De-identified data may be made available upon reasonable request, subject to approval by the research team, applicable ethical requirements, and institutional and data protection regulations.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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