The Effects of Increased Water Intake on Muscle Function, Physical Performance, and Endocrine Regulation in Low-Drinking Older Adults (HydraAge)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rúben Francisco Francisco, PhD
- Numéro de téléphone: +351 +351 243 309 520
- E-mail: rubenfrancisco@esdrm.ipsantarem.pt
Sauvegarde des contacts de l'étude
- Nom: Miguel Gomes Gomes, PhD
- Numéro de téléphone: +351 +351 912 332 444
- E-mail: miguel.gomes@esdrm.ipsantarem.pt
Lieux d'étude
-
-
-
Rio Maior, Le Portugal
- Recrutement
- Escola Superior de Desporto de Rio Maior
-
Contact:
- Rúben Francisco PhD
- Numéro de téléphone: +351 243 999 280
- E-mail: rubenfrancisco@esdrm.ipsantarem.pt
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥50 years.
- Habitual low water intake (≤35 ml/kg/day), confirmed through dietary assessment.
- Community-dwelling and able to attend study visits at the SPRINT laboratories.
- Independent ambulation (without an assistive device).
- Stable clinical condition for at least three months before enrollment.
- Auto reported adequate cognitive function to provide informed consent and comply with study procedures.
- Willingness to maintain habitual physical activity and dietary patterns (except for prescribed water intake modification)
Exclusion Criteria:
-
Clinically unstable cardiovascular disease.
-
Clinically unstable renal disease.
-
Clinically unstable metabolic or endocrine disease.
-
Clinically unstable type 2 diabetes.
-
Any medical condition requiring fluid restriction.
-
Known history of recurrent hyponatremia.
-
Chronic use of medications known to substantially affect fluid and electrolyte balance, including:- Loop diuretics;
- Thiazide diuretics;
- Desmopressin;
- Sodium-glucose cotransporter-2 (SGLT2) inhibitors.
-
Cognitive impairment preventing the provision of informed consent.
-
Musculoskeletal or neurological conditions that preclude participation in physical performance assessments.
-
Major surgery within the previous six months.
-
Current alcohol or substance abuse.
-
Participation in another clinical trial within the previous three months.
-
Any other condition considered by the investigators to compromise participant safety, study compliance, or interpretation of the study results.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Aucune intervention: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Absolute and Relative Ankle Plantar-Flexion Peak Force
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Complete the First Five Sit-to-Stand Repetitions
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Rúben Francisco Francisco, PhD, Sport Physical Activity and Health Research & Innovation Center
Publications et liens utiles
Publications générales
- Tinetti ME, Mendes de Leon CF, Doucette JT, Baker DI. Fear of falling and fall-related efficacy in relationship to functioning among community-living elders. J Gerontol. 1994 May;49(3):M140-7. doi: 10.1093/geronj/49.3.m140.
- Roussel R, Fezeu L, Bouby N, Balkau B, Lantieri O, Alhenc-Gelas F, Marre M, Bankir L; D.E.S.I.R. Study Group. Low water intake and risk for new-onset hyperglycemia. Diabetes Care. 2011 Dec;34(12):2551-4. doi: 10.2337/dc11-0652. Epub 2011 Oct 12.
- Johnson EC, Munoz CX, Jimenez L, Le Bellego L, Kupchak BR, Kraemer WJ, Casa DJ, Maresh CM, Armstrong LE. Hormonal and Thirst Modulated Maintenance of Fluid Balance in Young Women with Different Levels of Habitual Fluid Consumption. Nutrients. 2016 May 18;8(5):302. doi: 10.3390/nu8050302.
- Pross N, Demazieres A, Girard N, Barnouin R, Metzger D, Klein A, Perrier E, Guelinckx I. Effects of changes in water intake on mood of high and low drinkers. PLoS One. 2014 Apr 11;9(4):e94754. doi: 10.1371/journal.pone.0094754. eCollection 2014.
- Hornbrook MC, Stevens VJ, Wingfield DJ, Hollis JF, Greenlick MR, Ory MG. Preventing falls among community-dwelling older persons: results from a randomized trial. Gerontologist. 1994 Feb;34(1):16-23. doi: 10.1093/geront/34.1.16.
- Kenney WL, Chiu P. Influence of age on thirst and fluid intake. Med Sci Sports Exerc. 2001 Sep;33(9):1524-32. doi: 10.1097/00005768-200109000-00016.
- Carroll HA, Davis MG, Papadaki A. Higher plain water intake is associated with lower type 2 diabetes risk: a cross-sectional study in humans. Nutr Res. 2015 Oct;35(10):865-872. doi: 10.1016/j.nutres.2015.06.015. Epub 2015 Jul 2.
- Haussinger D, Lang F, Gerok W. Regulation of cell function by the cellular hydration state. Am J Physiol. 1994 Sep;267(3 Pt 1):E343-55. doi: 10.1152/ajpendo.1994.267.3.E343.
- Judelson DA, Maresh CM, Yamamoto LM, Farrell MJ, Armstrong LE, Kraemer WJ, Volek JS, Spiering BA, Casa DJ, Anderson JM. Effect of hydration state on resistance exercise-induced endocrine markers of anabolism, catabolism, and metabolism. J Appl Physiol (1985). 2008 Sep;105(3):816-24. doi: 10.1152/japplphysiol.01010.2007. Epub 2008 Jul 10.
- Armstrong LE, Bergeron MF, Munoz CX, Kavouras SA. Low daily water intake profile-is it a contributor to disease? Nutr Health. 2024 Sep;30(3):435-446. doi: 10.1177/02601060241238826. Epub 2024 Mar 22.
- Hakam N, Guzman Fuentes JL, Nabavizadeh B, Sudhakar A, Li KD, Nicholas C, Lui J, Tahir P, Jones CP, Bent S, Breyer BN. Outcomes in Randomized Clinical Trials Testing Changes in Daily Water Intake: A Systematic Review. JAMA Netw Open. 2024 Nov 4;7(11):e2447621. doi: 10.1001/jamanetworkopen.2024.47621.
- Yamada Y, Yoshida T, Yokoyama K, Watanabe Y, Miyake M, Yamagata E, Yamada M, Kimura M; Kyoto-Kameoka Study. The Extracellular to Intracellular Water Ratio in Upper Legs is Negatively Associated With Skeletal Muscle Strength and Gait Speed in Older People. J Gerontol A Biol Sci Med Sci. 2017 Mar 1;72(3):293-298. doi: 10.1093/gerona/glw125.
- Serra-Prat M, Lorenzo I, Palomera E, Yebenes JC, Campins L, Cabre M. Intracellular Water Content in Lean Mass is Associated with Muscle Strength, Functional Capacity, and Frailty in Community-Dwelling Elderly Individuals. A Cross-Sectional Study. Nutrients. 2019 Mar 19;11(3):661. doi: 10.3390/nu11030661.
- Ferry M. Strategies for ensuring good hydration in the elderly. Nutr Rev. 2005 Jun;63(6 Pt 2):S22-9. doi: 10.1111/j.1753-4887.2005.tb00151.x.
- Kavouras SA. Hydration, dehydration, underhydration, optimal hydration: are we barking up the wrong tree? Eur J Nutr. 2019 Mar;58(2):471-473. doi: 10.1007/s00394-018-01889-z. No abstract available.
- Lorenzo I, Serra-Prat M, Yebenes JC. The Role of Water Homeostasis in Muscle Function and Frailty: A Review. Nutrients. 2019 Aug 9;11(8):1857. doi: 10.3390/nu11081857.
- Cheung CL, Tan KC, Bow CH, Soong CS, Loong CH, Kung AW. Low handgrip strength is a predictor of osteoporotic fractures: cross-sectional and prospective evidence from the Hong Kong Osteoporosis Study. Age (Dordr). 2012 Oct;34(5):1239-48. doi: 10.1007/s11357-011-9297-2. Epub 2011 Aug 19.
- Han L, Yang F. Strength or power, which is more important to prevent slip-related falls? Hum Mov Sci. 2015 Dec;44:192-200. doi: 10.1016/j.humov.2015.09.001. Epub 2015 Sep 14.
- Valenzuela PL, Castillo-Garcia A, Morales JS, Izquierdo M, Serra-Rexach JA, Santos-Lozano A, Lucia A. Physical Exercise in the Oldest Old. Compr Physiol. 2019 Sep 19;9(4):1281-1304. doi: 10.1002/cphy.c190002.
- Alves T, Silva S, Braz P, Papadakaki M, Aniceto C, Mexia R, Matias-Dias C. Epidemiology of Falls Among Older Adults in Portugal: Analysis of Unintentional Injuries Reported by a National Emergency Surveillance System. Healthcare (Basel). 2025 May 16;13(10):1160. doi: 10.3390/healthcare13101160.
- Michel JP, Leonardi M, Martin M, Prina M. WHO's report for the decade of healthy ageing 2021-30 sets the stage for globally comparable data on healthy ageing. Lancet Healthy Longev. 2021 Mar;2(3):e121-e122. doi: 10.1016/S2666-7568(21)00002-7. Epub 2021 Mar 3. No abstract available.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies du système endocrinien
- Processus pathologiques
- Troubles nutritionnels
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies métaboliques
- Maladies de l'hypophyse
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Malnutrition
- Déshydratation
- Diabète insipide
- Déséquilibre eau-électrolyte
- Produits chimiques inorganiques
- Anions
- Ions
- Électrolytes
- Hydroxydes
- Alcalies
- Oxydes
- Composés d'oxygène
- Eau
Autres numéros d'identification d'étude
- HydrAge - SPRINT
- 2025 (Subvention/contrat des NIH des États-Unis)
- 2025.17619.PTDC (Autre subvention/numéro de financement: Fundação para a Ciência e Tecnologia)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .