- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00891514
Trial of Aerobic Exercise Training in Stroke Survivors
Aging, Inflammation and Exercise in Chronic Stroke
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Many stroke survivors are sedentary and are at risk for the development of diabetes. We will study the interactions of adipose tissue and the paretic and non-paretic muscle inflammation, insulin signaling and action in hemiparetic stroke patients and the ability to employ exercise training to reverse these abnormalities in this ethnically diverse population. Participants aged 40-75 years with chronic stroke will be randomized to treadmill training versus stretch control group using a one-two-one blocked randomization on race (black vs. white), sex (male vs. female), and glucose tolerance status (normal vs. impaired and type 2 diabetes).
Stroke occurs in over 780,000 persons each year in the U.S., the vast majority reported in persons older than 55 years of age. Following stroke, patients remain at continued high risk for recurrent stroke. Inflammatory processes lead to cardiovascular events/stroke and contribute to disease risk progression by impacting insulin resistance and the development of type 2 diabetes. Interventions that reduce inflammation and improve insulin sensitivity have important clinical implications, especially in the stroke population.
Task-oriented treadmill training is utilized to improve cardiovascular fitness and functional mobility in hemiparetic stroke patients. Additionally, preliminary data indicates that progressive treadmill training in this population improves glucose tolerance.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Maryland
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Baltimore, Maryland, Spojené státy, 20705
- University of Maryland, VAMC
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Ischemic or hemorrhagic stroke greater than or equal to 6 months prior with stable residual hemiparetic gait deficits
- Already completed all conventional inpatient and outpatient physical therapy
- Adequate language and neurocognitive function to safely participate in exercise testing and training
- Men or women ages 40-75 years
- Body mass index between 20 to 50 kg/m2
- Non-smoker, or history of no smoking for more than 5 years
- Under the care of a primary care medical provider
Exclusion Criteria:
- Already performing aerobic exercise 3 times a week
- Increased alcohol consumption defined as greater than 2 oz. liquor or 8 oz. of wine or 24 oz. of beer per day
Cardiac history of:
- unstable angina
- recent (less than 3 months prior to study entry) myocardial infarction, congestive heart failure
- hemodynamically significant valvular dysfunction
Medical History:
- recent hospitalization (less than 3 months prior to study entry) for severe medical disease
- peripheral arterial disease with vascular claudication
- orthopedic or chronic pain condition restricting exercise
- pulmonary or renal failure
- active cancer
- untreated poorly controlled hypertension measured on at least 2 occasions (greater than 160/100)
- type I diabetes mellitus, insulin therapy, untreated and/or poorly controlled diabetes with fasting blood glucose of greater than 160
- smoking within the last 5 years
- allergy to lidocaine
- medications: heparin, warfarin, lovenox, beta-blockers, oral steroids
Neurological history of:
- dementia with Mini-Mental Status Score less than 23 (less than 17 if education level at or below 8th grade), and diagnostic confirmation by neurologist or psychiatrist
- severe receptive or global aphasia which confounds testing and training, operationally defined as unable to follow 2 point commands
- hemiparetic gait from a prior stroke preceding the index stroke defining eligibility (more than one stroke)
- neurologic disorder restricting exercise, such as Parkinsons Syndrome or myopathy
- untreated major depression
Adipose tissue and muscle biopsy exclusion criteria:
- anti-coagulation therapy with heparin, warfarin, or lovenox (anti-platelet therapy is permitted)
- bleeding disorder
- allergy to lidocaine
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Aerobic Exercise
Treadmill training
|
Treadmill training- begins at 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 45-60 minutes for 6 months
|
Aktivní komparátor: Stretch Control
Stretching exercises
|
Stretching, balance exercises, and components of conventional physical therapy-- begins at 15 minutes and progresses to 45 minutes for 6 months
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
VO2peak
Časové okno: Baseline and 6 months
|
maximal oxygen consumption during a treadmill test
|
Baseline and 6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Whole body insulin sensitivity
Časové okno: Baseline and 6 months
|
glucose utilization during a glucose clamp
|
Baseline and 6 months
|
Cytokines
Časové okno: Baseline and 6 months
|
circulating TNF alpha levels
|
Baseline and 6 months
|
Body fat
Časové okno: Baseline and 6 months
|
whole body percent fat
|
Baseline and 6 months
|
Muscle mass
Časové okno: Baseline and 6 months
|
whole body lean mass
|
Baseline and 6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alice S. Ryan, PhD, University of Maryland, VA Research Service
- Vrchní vyšetřovatel: Charlene Hafer-Macko, MD, University of Maryland, VA Research Service, Department of Neurology
Publikace a užitečné odkazy
Obecné publikace
- Ivey FM, Ryan AS, Hafer-Macko CE, Goldberg AP, Macko RF. Treadmill aerobic training improves glucose tolerance and indices of insulin sensitivity in disabled stroke survivors: a preliminary report. Stroke. 2007 Oct;38(10):2752-8. doi: 10.1161/STROKEAHA.107.490391. Epub 2007 Aug 16.
- Ryan AS, Novitskaya M, Treuth AL. Predictive Equations Overestimate Resting Metabolic Rate in Survivors of Chronic Stroke. Arch Phys Med Rehabil. 2022 Jul;103(7):1352-1359. doi: 10.1016/j.apmr.2022.01.155. Epub 2022 Feb 19.
- Ryan AS, Dobrovolny CL, Smith GV, Silver KH, Macko RF. Hemiparetic muscle atrophy and increased intramuscular fat in stroke patients. Arch Phys Med Rehabil. 2002 Dec;83(12):1703-7. doi: 10.1053/apmr.2002.36399.
- Hafer-Macko CE, Yu S, Ryan AS, Ivey FM, Macko RF. Elevated tumor necrosis factor-alpha in skeletal muscle after stroke. Stroke. 2005 Sep;36(9):2021-3. doi: 10.1161/01.STR.0000177878.33559.fe. Epub 2005 Aug 18.
- Serra MC, Balraj E, DiSanzo BL, Ivey FM, Hafer-Macko CE, Treuth MS, Ryan AS. Validating accelerometry as a measure of physical activity and energy expenditure in chronic stroke. Top Stroke Rehabil. 2017 Jan;24(1):18-23. doi: 10.1080/10749357.2016.1183866. Epub 2016 Jun 20.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AG0118
- R01AG030075 (Grant/smlouva NIH USA)
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