SCOPE-Study: Salzburg Chronic Obstructive Pulmonary Disease- Exercise and Oxygen Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— SCOPE  

Official title:

The Effect of Supplemental Oxygen During Physical Exercise Training on Exercise Capacity in COPD Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150383
• Other study ID #: UISM-4
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2010
• Last updated: October 30, 2013
• Start date: July 2010
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• COPD with FEV1 pred. 30 to 60%, PO2 at rest > 55 mmHg and PCO2 < 45 mm Hg

• age: > 30 years

Exclusion Criteria:

• Musculoskeletal disease, which prohibits training

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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).
• 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).

Locations

Country	Name	City	State
Austria	Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity (Watts/kg)	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".	6 weeks	No
Secondary	Quality of life	Measured by St. George Respiratory Questionnaire	6 weeks	No
Secondary	Maximal oxygen uptake (VO2-max)	Measurement of spiroergometry	6 weeks	No
Secondary	Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.	Measurement of ergometry	6 weeks	No
Secondary	BODE-index	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.	6 weeks	No
Secondary	Walking capacity	6-minute-walk test	6 weeks	No
Secondary	Dyspnea	Measured by BORG-scale	6 weeks	No
Secondary	Body composition	Body composition/muscle volume will be measured using magnetic resonance imaging.	6 weeks	No
Secondary	Blood parameters of inflammation	Inflammatory changes will be assessed via blood test analysis.	6 weeks	No
Secondary	Vascular changes	Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.	6 weeks	No
Secondary	ten repetition maximum	The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.	6 weeks	No

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