Clinical trial NCT01150383: SCOPE-Study: Salzburg Chronic Obstructive Pulmonary Disease- Exercise and Oxygen Study
Official title: The Effect of Supplemental Oxygen During Physical Exercise Training on Exercise Capacity in COPD Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
COPD
Chronic Obstructive Lung Disease
Chronic Obstructive Airway Disease
Chronic Airflow Obstruction
oxygen
oxygen supplementation
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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:

* 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

Primary outcomes:
measure: Exercise capacity (Watts/kg)
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 6 weeks
measure: Maximal oxygen uptake (VO2-max)
timeFrame: 6 weeks
measure: Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.
timeFrame: 6 weeks
measure: BODE-index
timeFrame: 6 weeks
measure: Walking capacity
timeFrame: 6 weeks
measure: Dyspnea
timeFrame: 6 weeks
measure: Body composition
timeFrame: 6 weeks
measure: Blood parameters of inflammation
timeFrame: 6 weeks
measure: Vascular changes
timeFrame: 6 weeks
measure: ten repetition maximum
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Study officials:
affiliation: Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
name: Josef Niebauer, MD, PhD, MBA
role: STUDY_CHAIR
References:
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.
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;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.
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.
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.
citation: 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.
citation: 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.