- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01436318
Respiratory Muscle Strength and Function in Healthy Kids
Respiratory Muscle Strength and Function in Healthy Children
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The goals of this study are to collect and evaluate respiratory muscle strength training (RMST) induced changes in ventilatory function in healthy children. Children will undergo one session of pulmonary function and strength testing to quantify rate of inspiratory and expiratory pressure development and to determine whether inspiratory and expiratory pressure correlate to maximal respiratory pressures and forced pulmonary function tests. Currently normal pressure-flow-timing responses are not well-characterized in healthy children. The purpose of this study is to help develop more efficient RMST exercise prescriptions for ill children on ventilators and with neuromuscular weakness.
Participants in the study will refrain from caffeine products and exercise on the day of respiratory testing. In conjunction with respiratory testing, baseline and exertional blood pressure, heart and respiratory rate, and pulse oximetry will be monitored. Participants will complete tidal flow-volume assessments and forced expiratory maneuvers according to the AMerican Thoracic Society guidelines. Participants will undergo 5 sets of 10 maximal-effort breaths against standardized resistances (one set each at 0, 5, 10, 15, and 20 cm H20). Following each set, subjects will rate the load magnitude and their feelings of breathing discomfort using a 0-10 visual analog scale. Participants will also perform maximal inspiratory and expiratory pressure maneuvers. All tests will be separated by at least 2-3 minutes of rest.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Florida
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Gainesville, Florida, États-Unis, 32610
- University of Florida
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Male or female subjects 4-16 years of age.
- Healthy subjects
Exclusion Criteria:
- Have primary pulmonary disease
- Have primary neuromuscular disease
- Have a connective tissue or autoimmune disease
- Have had a respiratory infection with in 15 days prior to study date
- Have acute aminoglycosides antibiotic therapy with in 15 days prior to study date
- Have acute corticosteroids with in 15 days prior to study date
- Have a need to use an inhaler routinely
- Have hepatic failure
- Have hematologic failure
- Have participated in other studies related to medications or exercise
- Have used tobacco products
- Have other precautions
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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Respiratory Function
Children will undergo one session of pulmonary function and strength testing
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pulmonary Function Testing
Délai: Day 1
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Subjects will complete tidal flow-volume assessments and forced expiratory maneuvers.
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Day 1
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Barbara K Smith, PT, PhD, University of Florida
Publications et liens utiles
Publications générales
- Romer LM, McConnell AK. Specificity and reversibility of inspiratory muscle training. Med Sci Sports Exerc. 2003 Feb;35(2):237-44. doi: 10.1249/01.MSS.0000048642.58419.1E.
- American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Parthasarathy S, Jubran A, Laghi F, Tobin MJ. Sternomastoid, rib cage, and expiratory muscle activity during weaning failure. J Appl Physiol (1985). 2007 Jul;103(1):140-7. doi: 10.1152/japplphysiol.00904.2006. Epub 2007 Mar 29.
- Ramonatxo M, Amsalem FA, Mercier JG, Jean R, Prefaut CG. Ventilatory control during exercise in children with mild or moderate asthma. Med Sci Sports Exerc. 1989 Feb;21(1):11-7. doi: 10.1249/00005768-198902000-00003.
- Villafranca C, Borzone G, Leiva A, Lisboa C. Effect of inspiratory muscle training with an intermediate load on inspiratory power output in COPD. Eur Respir J. 1998 Jan;11(1):28-33. doi: 10.1183/09031936.98.11010028.
- Tzelepis GE, Vega DL, Cohen ME, Fulambarker AM, Patel KK, McCool FD. Pressure-flow specificity of inspiratory muscle training. J Appl Physiol (1985). 1994 Aug;77(2):795-801. doi: 10.1152/jappl.1994.77.2.795.
- Tzelepis GE, Kasas V, McCool FD. Inspiratory muscle adaptations following pressure or flow training in humans. Eur J Appl Physiol Occup Physiol. 1999 May;79(6):467-71. doi: 10.1007/s004210050538.
- Coast JR, Jensen RA, Cassidy SS, Ramanathan M, Johnson RL Jr. Cardiac output and O2 consumption during inspiratory threshold loaded breathing. J Appl Physiol (1985). 1988 Apr;64(4):1624-8. doi: 10.1152/jappl.1988.64.4.1624.
- Otis AB. Pressure-flow relationships and power output of breathing. Respir Physiol. 1977 Jun;30(1-2):7-14. doi: 10.1016/0034-5687(77)90017-2.
- Mognoni P, Saibene F, Sant'Ambrogio G, Agostoni E. Dynamics of the maximal contraction of the respiratory muscles. Respir Physiol. 1968 Mar;4(2):193-202. doi: 10.1016/0034-5687(68)90051-0. No abstract available.
- Read DJ, Freedman S, Kafer ER. Pressures developed by loaded inspiratory muscles in conscious and anesthetized man. J Appl Physiol. 1974 Aug;37(2):207-18. doi: 10.1152/jappl.1974.37.2.207. No abstract available.
- Pengelly LD, Alderson AM, Milic-Emili J. Mechanics of the diaphragm. J Appl Physiol. 1971 Jun;30(6):797-805. doi: 10.1152/jappl.1971.30.6.797. No abstract available.
- Ameredes BT, Zhan WZ, Prakash YS, Vandenboom R, Sieck GC. Power fatigue of the rat diaphragm muscle. J Appl Physiol (1985). 2000 Dec;89(6):2215-9. doi: 10.1152/jappl.2000.89.6.2215.
- Goldman MD, Grassino A, Mead J, Sears TA. Mechanics of the human diaphragm during voluntary contraction: dynamics. J Appl Physiol Respir Environ Exerc Physiol. 1978 Jun;44(6):840-8. doi: 10.1152/jappl.1978.44.6.840.
- Fitting JW, Easton PA, Grassino AE. Velocity of shortening of inspiratory muscles and inspiratory flow. J Appl Physiol (1985). 1986 Feb;60(2):670-7. doi: 10.1152/jappl.1986.60.2.670.
- Komarow HD, Myles IA, Uzzaman A, Metcalfe DD. Impulse oscillometry in the evaluation of diseases of the airways in children. Ann Allergy Asthma Immunol. 2011 Mar;106(3):191-9. doi: 10.1016/j.anai.2010.11.011. Epub 2011 Jan 6.
- Younes M, Riddle W. A model for the relation between respiratory neural and mechanical outputs. I. Theory. J Appl Physiol Respir Environ Exerc Physiol. 1981 Oct;51(4):963-78. doi: 10.1152/jappl.1981.51.4.963.
- Butler JE. Drive to the human respiratory muscles. Respir Physiol Neurobiol. 2007 Nov 15;159(2):115-26. doi: 10.1016/j.resp.2007.06.006. Epub 2007 Jun 17.
- Rowley KL, Mantilla CB, Sieck GC. Respiratory muscle plasticity. Respir Physiol Neurobiol. 2005 Jul 28;147(2-3):235-51. doi: 10.1016/j.resp.2005.03.003.
- Osborne S, Road JD. Diaphragm and phrenic nerve activities during inspiratory loading in anesthetized rabbits. Respir Physiol. 1995 Mar;99(3):321-30. doi: 10.1016/0034-5687(94)00109-d.
- American Thoracic Society; European Respiratory Society. ATS/ERS statement: raised volume forced expirations in infants: guidelines for current practice. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1463-71. doi: 10.1164/rccm.200408-1141ST. No abstract available.
- Polkey MI, Hamnegard CH, Hughes PD, Rafferty GF, Green M, Moxham J. Influence of acute lung volume change on contractile properties of human diaphragm. J Appl Physiol (1985). 1998 Oct;85(4):1322-8. doi: 10.1152/jappl.1998.85.4.1322.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Autres numéros d'identification d'étude
- HK 176-2011
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