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Effects of Exercise in People With Paraplegia

23 marzo 2015 aggiornato da: Mark S. Nash, Ph.D., FACSM, University of Miami

Exercise Treatment of Obesity-Related Secondary Conditions in Adults With Paraplegia

This hypothesis-driven study will investigate effects of physical activity with or without a nutrient supplement known to increase body lean mass in adults with chronic paraplegia who have clusters of obesity and obesity-related secondary complications.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Obesity and obesity-related secondary complications are pandemic health hazards that are highly prevalent among persons with spinal cord injuries (SCI). Accumulation of body fat disposes persons with SCI to accelerated endocrine and cardiovascular diseases, as well as pain, functional decline, and diminished health-related quality of life (HRQoL). While use of combined resistance and endurance exercise by persons without disability can remedy many of the problems associated with these disorders, their widespread use for persons with spinal cord injuries (SCI) must first satisfy scientific burdens of effectiveness.

The investigators have adopted the term "obesity-related secondary complications" to describe accumulation of body fat clustering with other secondary CVD risks, while recognizing that a threshold criterion for diagnosis of obesity in persons with SCI remains ill-defined. For purposes of this proposal, the "-related" part of the term confers physical deconditioning, hypertension, fasting dyslipidemia, post-prandial lipemia (PPL), and impaired insulin sensitivity, all of which have been reported in persons with SCI. Contextualized, any of these risks occurring independently or in clusters would be cause for immediate therapeutic lifestyle intervention (TLI), if not frank medical treatment. Given our early understanding of effective treatments for these risks, any improvement in their severity would be CVD risk-reducing and thus life-benefiting and function-preserving.

The investigators expect that the research findings will improve the understanding of risks for obesity and obesity-related secondary complications so that future interventions can be better targeted, identify an exercise intervention that can attend to current health risks, clarify whether nutrient supplementation improves risk-lessening benefits of exercise, identify exercise timing and intensities that best enhance fat utilization, and expand the understanding of the interrelated nature of risk factors after SCI.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Florida
      • Miami, Florida, Stati Uniti, 33136
        • The Miami Project to Cure Paralysis

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • SCI resulting in paraplegia between T5 and L1
  • injury for more than one year
  • American Spinal Injury Association Impairment Scale (AIS) grade A-C injuries

  • BMI ≥ 23 kg/m2 (defined by studies as the equivalent to the WHO criterion of 25 kg/m2 as 'overweight', and the point at which health risks begin to increase), plus any two or more of the following conditions on screening:

    1. prehypertension (BP ≥ 120/80 mmHg) by updated AHA and ADA criteria
    2. dyslipidemia (HDL-C ≥ 40 mg/dL or TG ≤ 150 mg/dL) by NCEP ATP III Guidelines,44 or
    3. impaired fasting glucose (≥ 100 mg/dL) by 2006 ADA criteria.

Exclusion Criteria:

  • surgery within 6 months
  • pressure ulcer within 3 months
  • upper limb pain that limits exercise
  • recurrent acute infection or illness requiring hospitalization or IV antibiotics
  • pregnancy
  • previous myocardial infarction or cardiac surgery
  • 6 month history of glucose lowering and lipid-lowering drug therapy
  • Type I or II diabetes (by WHO criteria)
  • daily intake of vitamin supplements exceeding 100% RDA
  • The following medications and drug therapies will disqualify subjects from participating: beta-adrenergic antagonists, maintenance alpha-blockers, Methyldopa, thiazide and loop diuretics, parasympatholytic agents, zinc, estrogen/hormone replacement therapy excluding oral contraceptives, insulin-sensitizing drugs, and maintenance use of aspirin and nonsteroidal anti-inflammatory drugs.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Supplement
Participants randomized to the 'supplement' arm will consume a blended drink containing 48g of ionexchange, hydrolyzed vanilla-flavored whey protein (Whey to Go, Solgar Vitamin and Herb, Leonia, NJ; 3g CH2O, < 3g Total Fat). The drink will be given in split doses immediately before and after each training session, which represents a timing schedule that best stimulates muscle anabolism in persons undergoing exercise training.
Altro: Exercise
CRT will occur 3 times per week for 26 weeks. Each training session will last approximately 40-45 minutes and employ resistance training (weight lifting) and high-speed, low intensity endurance activities (arm cranking) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
Altri nomi:
  • Circuit Resistance Training (CRT)
Comparatore placebo: Placebo
As ingestion of the protein supplement is critically influenced by time of administration, participants assigned to the 'placebo' study arm will consume the identical supplement and dose on days during which training is not performed. This strategy will allow the groups to be isocaloric and equal in protein supplementation.
Altro: Exercise
CRT will occur 3 times per week for 26 weeks. Each training session will last approximately 40-45 minutes and employ resistance training (weight lifting) and high-speed, low intensity endurance activities (arm cranking) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
Altri nomi:
  • Circuit Resistance Training (CRT)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Global cardiovascular disease risk score
Lasso di tempo: 4 visits over 9 months
Global cardiovacular disease risk will be generated by evaluating blood metabolism in the fasting and fed state for inflammatory disease markers including total cholesterol: high density lipoprotein ratio (TC: HDL ratio), post-prandial lipemia (PPL), whole body fat oxidation (WBFO), insulin resistance, and inflammatory mediators.
4 visits over 9 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body composition
Lasso di tempo: 4 visits over 9 months
The percent of muscle and fat in each participants' body will be measured by dual x-ray absorptiometry (DEXA) scan.
4 visits over 9 months
Cardiovascular Endurance
Lasso di tempo: 4 visits over 9 months
Endurance will be measured using a calibrated upper arm ergometer. An initial exercise workload of 0 Watts at 60 revolutions per minute (RPM) for three minutes will be followed by three minute stages increasing in 20 Watt increments. Responses to exercise will be continuously monitored via open-circuit spirometry and 12-lead electrocardiography. Peak Work will be defined as volitional fatigue, inability to maintain targeted workload, or the point at which increasing workload fails to further increase VO2.
4 visits over 9 months
Muscular strength
Lasso di tempo: 8 visits over 9 months
Upper extremity dynamic strength testing will be performed on a Helms equalizer 1000 multi-station exerciser using the following maneuvers: overhead press, horizontal row, vertical butterfly, biceps curl, latissimus pull down (either to the chest or neck), and dips. The 1-repetition maximum (1-RM) will be calculated using the Mayhew regression equation.
8 visits over 9 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Miami

Investigatori

  • Investigatore principale: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 ottobre 2008

Completamento primario (Effettivo)

1 settembre 2012

Completamento dello studio (Effettivo)

1 settembre 2012

Date di iscrizione allo studio

Primo inviato

15 settembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

15 settembre 2010

Primo Inserito (Stima)

16 settembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

24 marzo 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 marzo 2015

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TMP-MN-006

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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