SCOPE-Study: Salzburg Chronic Obstructive Pulmonary Disease- Exercise and Oxygen Study
Study Details
Study Description
Brief Summary
Chronic obstructive pulmonary disease (COPD) is number four of the leading causes of death in the USA and Europe. Moreover, among the top five causes of death, this disease is the only one with increasing mortality rates. Physical training has become an evidence based therapeutic intervention in these patients.
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 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. |
Other: 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 Names:
|
Active Comparator: 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). |
Other: 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).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Exercise capacity (Watts/kg) [6 weeks]
To investigate the effectiveness of physical training in COPD- patients comparing a 6 week period of exercise under oxygen supplementation with a 6 week period of exercise under "room air supplementation".
Secondary Outcome Measures
- Quality of life [6 weeks]
Measured by St. George Respiratory Questionnaire
- Maximal oxygen uptake (VO2-max) [6 weeks]
Measurement of spiroergometry
- Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4. [6 weeks]
Measurement of ergometry
- BODE-index [6 weeks]
The BODE index is a simple multidimensional grading system for COPD-patients which considers body-mass index, degree of airflow obstruction (FEV1) and dyspnea (BORG scale), and exercise capacity, which will be measured by the six-minute-walk test.
- Walking capacity [6 weeks]
6-minute-walk test
- Dyspnea [6 weeks]
Measured by BORG-scale
- Body composition [6 weeks]
Body composition/muscle volume will be measured using magnetic resonance imaging.
- Blood parameters of inflammation [6 weeks]
Inflammatory changes will be assessed via blood test analysis.
- Vascular changes [6 weeks]
Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.
- ten repetition maximum [6 weeks]
The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
COPD with FEV1 pred. 30 to 60%, PO2 at rest > 55 mmHg and PCO2 < 45 mm Hg
-
age: > 30 years
Exclusion Criteria:
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Musculoskeletal disease, which prohibits training
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Relevant neoplastic disease with cachexia
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Expected non compliance with the study protocol due to drug and alcohol abuse
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Coronary heart disease defined by angina pectoris or relevant ST-changes during exercise or myocardial infarction in the last 6 months
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Left ventricular ejection fraction < 40 %
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Renal insufficiency with creatinine > 2 mmol/liter
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Symptomatic intermittent claudication or peripheral neuropathy
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Anaemia < 10 mg/dl or red blood count < 3 Mio/mm3
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg | Salzburg | Austria | 5020 |
Sponsors and Collaborators
- Paracelsus Medical University
Investigators
- Study Chair: Josef Niebauer, MD, PhD, MBA, Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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. Review.
- 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;(2):CD005372. Review.
- Puhan MA, Schünemann 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. Review.
- 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.
- 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. Erratum in: Eur Respir J. 2010 Aug;36(2):462.
- 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.
- UISM-4