SCOPE-Study: Salzburg Chronic Obstructive Pulmonary Disease- Exercise and Oxygen Study
NCT ID: NCT01150383
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2010-07-31
2013-07-31
Brief Summary
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In this study the investigators aim to establish if supplemental oxygen during strength and endurance training improves exercise tolerance. Furthermore, the investigators want to research, if supplemental oxygen has the ability to increase training intensity, which would lead to a greater training effect with respect to respiratory, vascular, inflammatory and anthropometric parameters, as well as quality of life.
SCOPE is a prospective, randomized, double-blinded, controlled, cross-over trial. The investigators aim to enroll 40 patients suffering from COPD aged \>30 years. Inclusion criteria are FEV1 30-60%, and PO2 at rest \>55 mmHg. At baseline, patients will undergo pre-tests including pulmonary, exercise physiological and medical investigations. Prior to the exercise training, an intervention-free control period with usual care is planned. This will be followed by 2 x 6 weeks with physical training (ergometer based endurance training and strength training, using weight lifting machines) with either supplemental oxygen or usual room air (e.g.: first 6 weeks of exercise with oxygen supplementation followed by 6 weeks of room air). After the initial control period and between these two exercise periods, patients will be tested as described in pre-tests, and at the end of the second exercise training period. In addition, the investigators will assess changes in lung function and symptomatic dyspnoea, as well as in quality of life (St. George's Respiratory Questionnaire).
Within this study, the investigators hope to improve rehabilitation programs for COPD patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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group RO (Room air / Oxygen)
RO (Room air / Oxygen): First 6 weeks of exercise training under normoxic conditions (Room air), followed by 6 weeks of exercise training with oxygen supplementation.
Physical exercise training with "room air supplementation"
Prior to the exercise training, an intervention-free control period with usual care is planned.
Intervention group with room air supplementation: Endurance training (performed within 70-80% of the heart rate at the anaerobic threshold) as well as strength training will be performed under normoxic conditions.
After 6 weeks of intervention with room air, second intervention period will start with oxygen supplementation instead of room air (as described above).
group OR (Oxygen / Room air)
OR (Oxygen / Room air): First 6 weeks of exercise training with oxygen supplementation, followed by 6 weeks of exercise training under normoxic conditions (room air).
Physical exercise training with supplemental oxygen
Prior to the exercise training, an intervention-free control period with usual care is planned.
Intervention group with oxygen supplementation: Endurance training (performed within 70-80% of the heart rate at the anaerobic threshold) as well as strength training will be performed with oxygen supplementation.
After 6 weeks of intervention with oxygen supplementation, second intervention period will start with room air instead of oxygen supplementation (as described above).
Interventions
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Physical exercise training with supplemental oxygen
Prior to the exercise training, an intervention-free control period with usual care is planned.
Intervention group with oxygen supplementation: Endurance training (performed within 70-80% of the heart rate at the anaerobic threshold) as well as strength training will be performed with oxygen supplementation.
After 6 weeks of intervention with oxygen supplementation, second intervention period will start with room air instead of oxygen supplementation (as described above).
Physical exercise training with "room air supplementation"
Prior to the exercise training, an intervention-free control period with usual care is planned.
Intervention group with room air supplementation: Endurance training (performed within 70-80% of the heart rate at the anaerobic threshold) as well as strength training will be performed under normoxic conditions.
After 6 weeks of intervention with room air, second intervention period will start with oxygen supplementation instead of room air (as described above).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age: \> 30 years
Exclusion Criteria
* Relevant neoplastic disease with cachexia
* Expected non compliance with the study protocol due to drug and alcohol abuse
* Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
* Left ventricular ejection fraction \< 40 %
* Renal insufficiency with creatinine \> 2 mmol/liter
* Symptomatic intermittent claudication or peripheral neuropathy
* Anaemia \< 10 mg/dl or red blood count \< 3 Mio/mm3
30 Years
ALL
No
Sponsors
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Paracelsus Medical University
OTHER
Responsible Party
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Prof. Josef Niebauer M.D., Ph.D., MBA
Prim. Prof. MD, PhD, MBA
Principal Investigators
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Josef Niebauer, MD, PhD, MBA
Role: STUDY_CHAIR
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Locations
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Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, , Austria
Countries
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References
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Vogiatzis I, Athanasopoulos D, Stratakos G, Garagouni C, Koutsoukou A, Boushel R, Roussos C, Zakynthinos S. Exercise-induced skeletal muscle deoxygenation in O-supplemented COPD patients. Scand J Med Sci Sports. 2009 Jun;19(3):364-72. doi: 10.1111/j.1600-0838.2008.00808.x. Epub 2009 May 19.
Nonoyama ML, Brooks D, Lacasse Y, Guyatt GH, Goldstein RS. Oxygen therapy during exercise training in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.
ZuWallack RL. The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. Respir Care. 2008 Sep;53(9):1190-5.
Watz H, Waschki B, Meyer T, Magnussen H. Physical activity in patients with COPD. Eur Respir J. 2009 Feb;33(2):262-72. doi: 10.1183/09031936.00024608. Epub 2008 Nov 14.
Puhan MA, Schunemann HJ, Frey M, Scharplatz M, Bachmann LM. How should COPD patients exercise during respiratory rehabilitation? Comparison of exercise modalities and intensities to treat skeletal muscle dysfunction. Thorax. 2005 May;60(5):367-75. doi: 10.1136/thx.2004.033274.
Casaburi R, ZuWallack R. Pulmonary rehabilitation for management of chronic obstructive pulmonary disease. N Engl J Med. 2009 Mar 26;360(13):1329-35. doi: 10.1056/NEJMct0804632. No abstract available.
Neunhauserer D, Hudelmaier M, Niederseer D, Vecchiato M, Wirth W, Steidle-Kloc E, Kaiser B, Lamprecht B, Ermolao A, Studnicka M, Niebauer J. The Impact of Exercise Training and Supplemental Oxygen on Peripheral Muscles in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Dec 1;55(12):2123-2131. doi: 10.1249/MSS.0000000000003268. Epub 2023 Aug 2.
Related Links
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Related Info
Other Identifiers
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UISM-4
Identifier Type: -
Identifier Source: org_study_id