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- Klinische proef NCT00877084
Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease (EXTRA)
Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD
When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with a severe exacerbation they lose muscle strength. This muscle weakness predisposes these patients to further hospital admissions. Resistance training is a potent countermeasure to prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention however has not been validated.
The present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle strength and hospital readmission and functional status at discharge. Using the minimally invasive needle muscle biopsy technique described by Bergström the effects of resistance training on the skeletal muscle will be analyzed in detail.
After giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. Patients will be followed-up using the clinical pathway for COPD (10 days). After one month patients will attend the outpatient clinic for a follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. Half of the patients will receive a resistance training program. At the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Leuven, België, 3000
- Universitair Ziekenhuis Leuven, Campus Gasthuisberg
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion criteria:
- COPD exacerbation, admitted to the respiratory units
- Informed consent
- Age < 80
- No critical comorbidity compromising outcome up to one month.
- No suspect of malignancy
Exclusion criteria:
- Patient is involved in a rehabilitation program with a frequency >1/wk during one month after inclusion in the study
- NIMV or ICU on admission
- Patient scheduled for procedure (LTX/LVRS) within one month after discharge
- Readmission <14 days after previous hospitalization
- Significant pathology that would hinder the participation in resistance training (gonarthrosis, arthritis to be judged by the investigator)
- Clinical signs of pulmonary hypertension
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 1
Resistance training: series of 3x8 repetitions will be performed for the quadriceps muscle at 70% of the 1 Repetition Maximum determined as the weight the patient can lift once over the full range of motion.
The weight can be applied using free weights or using a classical multi-gym device or a quadriceps chair.
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Resistance training: series of 3x8 repetitions will be performed for the quadriceps muscle at 70% of the 1 Repetition Maximum determined as the weight the patient can lift once over the full range of motion.
The weight can be applied using free weights or using a classical multi-gym device or a quadriceps chair.
Andere namen:
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Placebo-vergelijker: 2
Usual care according to clinical pathway for COPD exacerbations + NO training
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usual care according to clinical pathway for COPD, No training
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Reduction in the decline of muscle force during the exacerbation.
Tijdsspanne: discharge Day 9
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discharge Day 9
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Time to readmission or death
Tijdsspanne: 6 Months
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6 Months
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Functional exercise capacity at discharge (6MWT)
Tijdsspanne: discharge Day 9
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discharge Day 9
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Functional exercise capacity and muscle force at 1 month
Tijdsspanne: 1 Month
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1 Month
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Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.
Tijdsspanne: Day 9
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Day 9
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 1.5.139.06KAN
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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