NCT05380089

Brief Summary

Greater muscular strength and power are relevant qualities for athletic success and decreased injury rate. It is known that dehydration impairs muscular strength and power, although the explanation for this association is not entirely clear. Besides morphological factors, strength production also depends on neural factors which in turn can be affected by dehydration. Some studies tested the effects of dehydration on neuromuscular function using electromyography (EMG) analysis. However, there is no consensus among those studies. Additionally, exercise may disturb water balance. This can further lead to dehydration if the athlete does not properly rehydrate. In this sense, the scientific evidence has identified people who are considered low drinkers that may be more susceptible to cellular shrinkage, potentially impairing health and performance. Thus, it would be expected that athletes regularly exposed to lower amounts of water intake would have beneficial effects in both performance and health if higher water ingestion was promoted, namely an improved neuromuscular function via enhanced cellular hydration. However, any potential benefit of increasing water intake on neuromuscular function is still to be determined using well-designed experimental studies and state-of-the-art methods. Lastly, there is no consensus regarding the diagnosis of dehydration in athletes. The identification of simple indices to measure dehydration in athletes is crucial as many may be inaccurately diagnosed.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

3 years

First QC Date

May 13, 2022

Last Update Submit

May 28, 2024

Conditions

Keywords

Electromyographyhydration statusneuromuscular activationmuscle strengthmuscle powerhydration assessmentdehydrationbody composition

Outcome Measures

Primary Outcomes (8)

  • Maximum voluntary isometric contraction - Knee extension

    For the lower body strength, participants will be assessed on a Biodex System 3 Pro isokinetic dynamometer (Biodex Medical Systems, Shirley, NY). The participants will remain seated with the belts positioned on the thorax, abdomen, thigh, and above the knee on the side that is being evaluated to limit the knee movement. Each testing session will begin with a dynamic warm-up, consisting of 5min of submaximal cycle-ergometry set at 25 W followed by a 5 min of resting before starting the testing protocol. First, a MVIC 5-s voluntary knee extension (knee at 70o for the extension). Verbal encouragement and audible feedback from the dynamometer software will be provided to each participant.

    3 weeks

  • Maximum voluntary isometric contraction - Knee flexion

    After the maximum voluntary isometric contraction for knee extension, participants will be asked to perform a MVIC 5-s voluntary knee flexion (30o for the flexion). This test will be performed with 3min of pause after the MVIC of knee extension.

    3 weeks

  • Rate of torque development (RTD) for knee extension and flexion

    In both MVIC for knee extension and flexion, the participants will be instructed to avoid any countermovement prior to test and will be asked to exert their maximum force as fast and hard as possible, to obtain both maximal torque and rate of torque development (RTD). Verbal encouragement and audible feedback from the dynamometer software will be provided to each participant.

    3 weeks

  • 5 submaximal isometric repetitions of knee extension

    5 submaximal isometric repetitions will me measuredfrom MVIC of baseline and MVIC of that day: 1) 30s at 20% of MVIC; 2) 30s at 40% of MVIC; 3) 10s at 60% of MVIC; 4) 10s at 80% of MVIC; 5) 10s at 100% of MVIC. Between repetitions a pause of 1 min will be performed between repetitions while a pause of 3 min will be performed between sets.

    3 weeks

  • Fatigue task

    Last, and after a pause of 5 min, participants will perform an isometric contraction at 40% of MVIC (measured on the day) until to exhaustion. Exhaustion will be considered if a decrease of more than 10% of MVIC for more than 10s is observed.

    3 weeks

  • EMG signals - Root mean square

    During the legs' strength assessment, EMG signals will be recorded (EMG Delsys Trigno Avanti, Delsys Incorporated, USA) from the vastus lateralis (VL), rectus femoris (RF), vastus medialis (VM), and biceps femoris (BF) muscles in accordance with the guidelines of the Surface EMG for the Non-invasive Assessment of Muscles (SENIAM). The electrodes will be placed before the 5 min of resting after the dynamic warm-up. EMG signals from each muscle will be pre-amplified (gain 1000), band-pass filtered (20-450 Hz), and A/D converted at 1kHz (MP100, BIOPAC Systems Inc., Goleta, CA). AcqKnowledge 4.3.1 software will be used for data collection and processing (BIOPAC Systems Inc., Goleta, CA).

    3 weeks

  • EMG signals - Mean power frequency

    During the legs' strength assessment, EMG signals will be recorded (EMG Delsys Trigno Avanti, Delsys Incorporated, USA) from the vastus lateralis (VL), rectus femoris (RF), vastus medialis (VM), and biceps femoris (BF) muscles in accordance with the guidelines of the Surface EMG for the Non-invasive Assessment of Muscles (SENIAM). The electrodes will be placed before the 5 min of resting after the dynamic warm-up. EMG signals from each muscle will be pre-amplified (gain 1000), band-pass filtered (20-450 Hz), and A/D converted at 1kHz (MP100, BIOPAC Systems Inc., Goleta, CA). AcqKnowledge 4.3.1 software will be used for data collection and processing (BIOPAC Systems Inc., Goleta, CA).

    3 weeks

  • Handgrip strength

    The handgrip strength test measures maximum voluntary isometric contraction (MVIC) of the hand and forearm muscles. Handgrip will be performed using a portable hand dynamometer (TSD121C; Biopac Systems, Goleta, CA, USA). Participants will be assessed on both hands alternately, in a standing position. Prior to the test, the grip dynamometer will be adjusted to the size of the hand of each subject. Handgrip strength assessment will be conducted with the subject standing up with the arms in a neutral position (halfway between supine and pronation position). Each participant will be assessed on both hands alternately until reaching 3 attempts for each hand. In each attempt, the subject will exert the maximal grip strength on the handgrip dynamometer with the assessed hand for 5s. After each attempt, there will be a resting period of 60s that will be used both for recovery and for changing the handgrip dynamometer to the opposite hand.

    3 weeks

Secondary Outcomes (21)

  • Food records

    3 weeks

  • Cardiorespiratory Fitness Test

    3 weeks

  • Plasma osmolality

    3 weeks

  • Urine osmolality

    3 weeks

  • Saliva osmolality

    3 weeks

  • +16 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Over a 4-day period, participants randomly assigned to the experimental group will be instructed to maintain normal solid food choices, but to increase water intake to achieve a total water intake of ≥45ml/kg/day. Prepared bottles of water with the required amount will be given to each participant every morning and collected empty the following day. Instructions to drink small amounts of water every hour be transmitted. Adherence to instructions regarding water intake will be determined by the return of drinking bottles, analysis of daily food records, assessment of water flux (i.e., collecting urines after subjects being dosed with deuterium), and daily screening questions. These samples will be delivered on a subsequent morning during a daily laboratory visit to collect urine and saliva samples, as well as BI assessment. On the 4th day, participants will perform a neuromuscular function assessment.

Other: Increasing water intake

Control group

NO INTERVENTION

Participants randomly assigned to the control group will be instructed to maintain normal solid food choices and water intake based on their average intake reported on the food records. Adherence to instructions regarding water intake will be determined and assessments performed will occur as mentioned previously for the experimental group.

Interventions

Participants randomly assigned to the experimental group will be instructed to maintain habitual solid food choices and to increase water intake to achieve a total water intake of ≥45ml/kg/day.

Experimental group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Highly trained athletes (i.e., participating in national and international championships and/or ≥6 h of training per week)
  • Athletes considered low drinkers (i.e., total water intake ≤ 35ml/kg/)
  • Aged between 18 and 35 years
  • Living in Lisbon and/or its surroundings
  • All women should have a (self-reported) normal menstrual cycle (i.e., cycles at median intervals of less than 35 days)
  • Completion of the sport's medical examination

You may not qualify if:

  • Total water intake above 35ml/kg/day.
  • Clinical history compatible with exertional heat illness (i.e., heat stroke, heat exhaustion, hyperthermia, among other events that suggest poor response to thermically challenging environments)
  • Taking medication known to alter the normal fluid-electrolyte balance, plasma osmolality, urinary osmolality, or the chronotropic response to exercise (e.g., diuretics, antidiuretics, laxatives, oral contraceptives, drugs to control blood pressure (39)
  • Exhibiting self-reported metabolic disorders or malfunction of salivary glands
  • Active smoking status
  • Unwilling to abstain from alcohol during this study
  • Respiratory disorders, including asthma
  • Injuries that would limit exercise performance
  • Mechanical prostheses
  • Pregnancy /planning to get pregnant within the next 8 months
  • Having been pregnant within the past 6 months or breastfeeding
  • Failure to complete the dietary intake and physical activity recording
  • Unable to communicate with local study staff
  • Needle phobia
  • Inability to complete the study within the designated time frame because of plans to move out of the study area or occurrence of competition periods during the study timeframe
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade Motricidade Humana

Lisbon, 1495-751, Portugal

RECRUITING

Related Publications (39)

  • Suchomel TJ, Nimphius S, Stone MH. The Importance of Muscular Strength in Athletic Performance. Sports Med. 2016 Oct;46(10):1419-49. doi: 10.1007/s40279-016-0486-0.

    PMID: 26838985BACKGROUND
  • Judelson DA, Maresh CM, Anderson JM, Armstrong LE, Casa DJ, Kraemer WJ, Volek JS. Hydration and muscular performance: does fluid balance affect strength, power and high-intensity endurance? Sports Med. 2007;37(10):907-21. doi: 10.2165/00007256-200737100-00006.

    PMID: 17887814BACKGROUND
  • Suchomel TJ, Nimphius S, Bellon CR, Stone MH. The Importance of Muscular Strength: Training Considerations. Sports Med. 2018 Apr;48(4):765-785. doi: 10.1007/s40279-018-0862-z.

    PMID: 29372481BACKGROUND
  • Folland JP, Williams AG. The adaptations to strength training : morphological and neurological contributions to increased strength. Sports Med. 2007;37(2):145-68. doi: 10.2165/00007256-200737020-00004.

    PMID: 17241104BACKGROUND
  • Casa DJ. Exercise in the heat. I. Fundamentals of thermal physiology, performance implications, and dehydration. J Athl Train. 1999 Jul;34(3):246-52.

    PMID: 16558572BACKGROUND
  • Sjogaard G. Water and electrolyte fluxes during exercise and their relation to muscle fatigue. Acta Physiol Scand Suppl. 1986;556:129-36.

    PMID: 3471050BACKGROUND
  • Barley OR, Chapman DW, Blazevich AJ, Abbiss CR. Acute Dehydration Impairs Endurance Without Modulating Neuromuscular Function. Front Physiol. 2018 Nov 2;9:1562. doi: 10.3389/fphys.2018.01562. eCollection 2018.

    PMID: 30450056BACKGROUND
  • Ftaiti F, Grelot L, Coudreuse JM, Nicol C. Combined effect of heat stress, dehydration and exercise on neuromuscular function in humans. Eur J Appl Physiol. 2001 Jan-Feb;84(1-2):87-94. doi: 10.1007/s004210000339.

    PMID: 11394259BACKGROUND
  • Evetovich TK, Boyd JC, Drake SM, Eschbach LC, Magal M, Soukup JT, Webster MJ, Whitehead MT, Weir JP. Effect of moderate dehydration on torque, electromyography, and mechanomyography. Muscle Nerve. 2002 Aug;26(2):225-31. doi: 10.1002/mus.10203.

    PMID: 12210387BACKGROUND
  • Bigard AX, Sanchez H, Claveyrolas G, Martin S, Thimonier B, Arnaud MJ. Effects of dehydration and rehydration on EMG changes during fatiguing contractions. Med Sci Sports Exerc. 2001 Oct;33(10):1694-700. doi: 10.1097/00005768-200110000-00013.

    PMID: 11581554BACKGROUND
  • Rodger A, Papies EK. "I don't just drink water for the sake of it": Understanding the influence of value, reward, self-identity and early life on water drinking behaviour. Food Quality and Preference. 2022;99:104576.

    BACKGROUND
  • Cheuvront SN, Kenefick RW. Dehydration: physiology, assessment, and performance effects. Compr Physiol. 2014 Jan;4(1):257-85. doi: 10.1002/cphy.c130017.

    PMID: 24692140BACKGROUND
  • Belval LN, Hosokawa Y, Casa DJ, Adams WM, Armstrong LE, Baker LB, Burke L, Cheuvront S, Chiampas G, Gonzalez-Alonso J, Huggins RA, Kavouras SA, Lee EC, McDermott BP, Miller K, Schlader Z, Sims S, Stearns RL, Troyanos C, Wingo J. Practical Hydration Solutions for Sports. Nutrients. 2019 Jul 9;11(7):1550. doi: 10.3390/nu11071550.

    PMID: 31324008BACKGROUND
  • Periard JD, Racinais S, Sawka MN. Adaptations and mechanisms of human heat acclimation: Applications for competitive athletes and sports. Scand J Med Sci Sports. 2015 Jun;25 Suppl 1:20-38. doi: 10.1111/sms.12408.

    PMID: 25943654BACKGROUND
  • Perrier E, Vergne S, Klein A, Poupin M, Rondeau P, Le Bellego L, Armstrong LE, Lang F, Stookey J, Tack I. Hydration biomarkers in free-living adults with different levels of habitual fluid consumption. Br J Nutr. 2013 May;109(9):1678-87. doi: 10.1017/S0007114512003601. Epub 2012 Aug 31.

    PMID: 22935250BACKGROUND
  • Armstrong LE, Munoz CX, Armstrong EM. Distinguishing Low and High Water Consumers-A Paradigm of Disease Risk. Nutrients. 2020 Mar 23;12(3):858. doi: 10.3390/nu12030858.

    PMID: 32210168BACKGROUND
  • Johnson EC, Munoz CX, Le Bellego L, Klein A, Casa DJ, Maresh CM, Armstrong LE. Markers of the hydration process during fluid volume modification in women with habitual high or low daily fluid intakes. Eur J Appl Physiol. 2015 May;115(5):1067-74. doi: 10.1007/s00421-014-3088-2. Epub 2015 Jan 7.

    PMID: 25564016BACKGROUND
  • 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.

    PMID: 27213436BACKGROUND
  • Leiper JB, Pitsiladis Y, Maughan RJ. Comparison of water turnover rates in men undertaking prolonged cycling exercise and sedentary men. Int J Sports Med. 2001 Apr;22(3):181-5. doi: 10.1055/s-2001-15912.

    PMID: 11354520BACKGROUND
  • 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.

    PMID: 24728141BACKGROUND
  • American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597.

    PMID: 17277604BACKGROUND
  • EFSA Panel on Dietetic Products N, Allergies. Scientific Opinion on Dietary Reference Values for water. EFSA Journal. 2010;8(3):1459.

    BACKGROUND
  • Nunes CL, Matias CN, Santos DA, Morgado JP, Monteiro CP, Sousa M, Minderico CS, Rocha PM, St-Onge MP, Sardinha LB, Silva AM. Characterization and Comparison of Nutritional Intake between Preparatory and Competitive Phase of Highly Trained Athletes. Medicina (Kaunas). 2018 May 30;54(3):41. doi: 10.3390/medicina54030041.

    PMID: 30344272BACKGROUND
  • Pilis K, Stec K, Pilis A, Mroczek A, Michalski C, Pilis W. Body composition and nutrition of female athletes. Rocz Panstw Zakl Hig. 2019;70(3):243-251. doi: 10.32394/rpzh.2019.0074.

    PMID: 31515983BACKGROUND
  • Nuccio RP, Barnes KA, Carter JM, Baker LB. Fluid Balance in Team Sport Athletes and the Effect of Hypohydration on Cognitive, Technical, and Physical Performance. Sports Med. 2017 Oct;47(10):1951-1982. doi: 10.1007/s40279-017-0738-7.

    PMID: 28508338BACKGROUND
  • Arnaoutis G, Kavouras SA, Angelopoulou A, Skoulariki C, Bismpikou S, Mourtakos S, Sidossis LS. Fluid Balance During Training in Elite Young Athletes of Different Sports. J Strength Cond Res. 2015 Dec;29(12):3447-52. doi: 10.1519/JSC.0000000000000400.

    PMID: 24513625BACKGROUND
  • Hall JE. Guyton and Hall textbook of medical physiology e-Book: Elsevier Health Sciences; 2015.

    BACKGROUND
  • Silva AM, Fields DA, Heymsfield SB, Sardinha LB. Body composition and power changes in elite judo athletes. Int J Sports Med. 2010 Oct;31(10):737-41. doi: 10.1055/s-0030-1255115. Epub 2010 Jul 19.

    PMID: 20645233BACKGROUND
  • Silva AM, Fields DA, Heymsfield SB, Sardinha LB. Relationship between changes in total-body water and fluid distribution with maximal forearm strength in elite judo athletes. J Strength Cond Res. 2011 Sep;25(9):2488-95. doi: 10.1519/JSC.0b013e3181fb3dfb.

    PMID: 21869630BACKGROUND
  • Silva AM, Matias CN, Santos DA, Rocha PM, Minderico CS, Sardinha LB. Increases in intracellular water explain strength and power improvements over a season. Int J Sports Med. 2014 Dec;35(13):1101-5. doi: 10.1055/s-0034-1371839. Epub 2014 Jul 10.

    PMID: 25009970BACKGROUND
  • Armstrong LE. Assessing hydration status: the elusive gold standard. J Am Coll Nutr. 2007 Oct;26(5 Suppl):575S-584S. doi: 10.1080/07315724.2007.10719661.

    PMID: 17921468BACKGROUND
  • Armstrong LE, Maughan RJ, Senay LC, Shirreffs SM. Limitations to the use of plasma osmolality as a hydration biomarker. Am J Clin Nutr. 2013 Aug;98(2):503-4. doi: 10.3945/ajcn.113.065466. No abstract available.

    PMID: 23873679BACKGROUND
  • Barley OR, Chapman DW, Abbiss CR. Reviewing the current methods of assessing hydration in athletes. J Int Soc Sports Nutr. 2020 Oct 30;17(1):52. doi: 10.1186/s12970-020-00381-6.

    PMID: 33126891BACKGROUND
  • Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.

    PMID: 15380917BACKGROUND
  • Hetherington-Rauth M, Leu CG, Judice PB, Correia IR, Magalhaes JP, Sardinha LB. Whole body and regional phase angle as indicators of muscular performance in athletes. Eur J Sport Sci. 2021 Dec;21(12):1684-1692. doi: 10.1080/17461391.2020.1858971. Epub 2021 Jan 18.

    PMID: 33280537BACKGROUND
  • Raman A, Schoeller DA, Subar AF, Troiano RP, Schatzkin A, Harris T, Bauer D, Bingham SA, Everhart JE, Newman AB, Tylavsky FA. Water turnover in 458 American adults 40-79 yr of age. Am J Physiol Renal Physiol. 2004 Feb;286(2):F394-401. doi: 10.1152/ajprenal.00295.2003. Epub 2003 Nov 4.

    PMID: 14600032BACKGROUND
  • Stegeman D, Hermens H. Standards for surface electromyography: The European project Surface EMG for non-invasive assessment of muscles (SENIAM). Enschede: Roessingh Research and Development. 2007:108-12.

    BACKGROUND
  • Puga AM, Lopez-Oliva S, Trives C, Partearroyo T, Varela-Moreiras G. Effects of Drugs and Excipients on Hydration Status. Nutrients. 2019 Mar 20;11(3):669. doi: 10.3390/nu11030669.

    PMID: 30897748BACKGROUND
  • Francisco R, Jesus F, Nunes CL, Santos P, Alvim M, Campa F, Schoeller DA, Lukaski H, Mendonca GV, Sardinha LFCB, Silva AMLA. H2OAthletes study protocol: effects of hydration changes on neuromuscular function in athletes. Br J Nutr. 2024 May 14;131(9):1579-1590. doi: 10.1017/S0007114524000308. Epub 2024 Feb 1.

MeSH Terms

Conditions

DehydrationWater Intoxication

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsPoisoningChemically-Induced Disorders

Study Officials

  • Analiza Silva, PhD

    Faculdade Motricidade Humana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruben Francisco, MSc

CONTACT

Filipe Jesus, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Given the nature of the study, it is not possible to blind neither participants nor research team members regarding the allocated groups.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: A randomized controlled trial (RCT)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

November 1, 2021

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations