- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00572845
Energy Costs of Spasticity in Spinal Cord Injury: A Pilot Investigation
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Obesity is at epidemic proportions in the population with spinal cord injury (SCI), and is likely the mediator of the metabolic syndrome in this special population. Recent literature reviews have suggested that obesity is present in > 67% of persons with SCI. Additionally, recent studies have demonstrated the causal relationship between adipose tissue accumulation and vascular inflammation, dyslipidemia, insulin resistance / glucose intolerance, hypertension and thromboemboli.
Obesity in SCI occurs because of acute and ongoing positive energy balance, i.e., greater caloric intake than energy expenditure. Total Daily Energy Expenditure (TDEE) in SCI is reduced primarily because of muscular atrophy and diminished muscular contraction; pharmacological treatment of spasticity possibly reduces energy expenditure (EE) even further, but has not been evaluated to date. TDEE is comprised of three components: Basal Energy Expenditure (BEE), Thermic Effect of Activity (TEA) and Thermic Effect of Food (TEF). Of the three, BEE contributes the greatest amount (65-75% TDEE) and is the most sensitive to changes in spasticity.
Dampening spasticity has been reported to increase weight gain and necessitate reduced caloric intake in a child with spastic quadriplegia. Similarly, athetosis in patients with cerebral palsy increased resting metabolic rate (RMR) as compared to control subjects with no athetotic movements. Although several studies have reported energy requirements for persons with neurodevelopmental disabilities, and even SCI, however, none have attempted to measure the metabolic effect of spasticity.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Virginia
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Richmond, Virginia, Stati Uniti, 23249
- McGuire VA Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- C1-T10 SCI at least 1 year post injury
- Spasticity in the legs
- Veteran
Exclusion Criteria:
- Recent increase in spasticity
- Botox within 6 months
- Phenol within 2 years
- Prior surgery for spasticity
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 1
Weaning of Spasticity Medication over a three day period while measuring Modified Ashworth Scale and Penn Spasm Frequency Score.
Then titration of medication back to previous dose over a three day period.
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Weaning of antispasticity medication over a three day period and then titration back to previous dose over a three day period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Increase in Basal Energy Expenditure
Lasso di tempo: 7 days
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7 days
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: David R Gater, MD, PhD, McGuire VA Medical Center
- Cattedra di studio: David X Cifu, MD, VCU Department of Physical Medicine and Rehabilitation
Pubblicazioni e link utili
Pubblicazioni generali
- Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Buchholz AC, McGillivray CF, Pencharz PB. Differences in resting metabolic rate between paraplegic and able-bodied subjects are explained by differences in body composition. Am J Clin Nutr. 2003 Feb;77(2):371-8. doi: 10.1093/ajcn/77.2.371.
- Gater DR Jr. Obesity after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):333-51, vii. doi: 10.1016/j.pmr.2007.03.004.
- Bauman WA, Spungen AM, Wang J, Pierson RN Jr. The relationship between energy expenditure and lean tissue in monozygotic twins discordant for spinal cord injury. J Rehabil Res Dev. 2004 Jan-Feb;41(1):1-8. doi: 10.1682/jrrd.2004.01.0001.
- Hemingway C, McGrogan J, Freeman JM. Energy requirements of spasticity. Dev Med Child Neurol. 2001 Apr;43(4):277-8. doi: 10.1017/s0012162201000524.
- Dickerson RN, Brown RO, Gervasio JG, Hak EB, Hak LJ, Williams JE. Measured energy expenditure of tube-fed patients with severe neurodevelopmental disabilities. J Am Coll Nutr. 1999 Feb;18(1):61-8. doi: 10.1080/07315724.1999.10718828.
- Cox SA, Weiss SM, Posuniak EA, Worthington P, Prioleau M, Heffley G. Energy expenditure after spinal cord injury: an evaluation of stable rehabilitating patients. J Trauma. 1985 May;25(5):419-23.
- Rodriguez DJ, Benzel EC, Clevenger FW. The metabolic response to spinal cord injury. Spinal Cord. 1997 Sep;35(9):599-604. doi: 10.1038/sj.sc.3100439.
- Rodriguez DJ, Clevenger FW, Osler TM, Demarest GB, Fry DE. Obligatory negative nitrogen balance following spinal cord injury. JPEN J Parenter Enteral Nutr. 1991 May-Jun;15(3):319-22. doi: 10.1177/0148607191015003319.
- Penn RD. Intrathecal baclofen for severe spasticity. Ann N Y Acad Sci. 1988;531:157-66. doi: 10.1111/j.1749-6632.1988.tb31822.x. No abstract available.
- Gorgey AS, Gater DR Jr. Prevalence of Obesity After Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2007 Spring;12(4):1-7. doi: 10.1310/sci1204-1.
- Clasey JL, Gater DR. Body Composition Assessment in Adults with Spinal Cord Injury. Topics in Spinal Cord Injury Rehabilitation. 2007;12(4):8-19.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Manifestazioni neurologiche
- Ferite e lesioni
- Malattie muscoloscheletriche
- Malattie muscolari
- Manifestazioni neuromuscolari
- Trauma, sistema nervoso
- Malattie del midollo spinale
- Ipertono muscolare
- Lesioni del midollo spinale
- Spasticità muscolare
Altri numeri di identificazione dello studio
- HM11352
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