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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Physical exercise training with "room air supplementation"; Other: Physical exercise training with supplemental oxygen

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria, 5020
    • Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: exercise; training; physical training
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: exercise; training; physical training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Measured by St. George Respiratory Questionnaire	6 weeks
Maximal oxygen uptake (VO2-max)	Measurement of spiroergometry	6 weeks
Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.	Measurement of ergometry	6 weeks
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
Walking capacity	6-minute-walk test	6 weeks
Dyspnea	Measured by BORG-scale	6 weeks
Body composition	Body composition/muscle volume will be measured using magnetic resonance imaging.	6 weeks
Blood parameters of inflammation	Inflammatory changes will be assessed via blood test analysis.	6 weeks
Vascular changes	Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.	6 weeks
ten repetition maximum	The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.	6 weeks

Collaborators and Investigators

• Sponsor: Paracelsus Medical University
• Investigators: Study Chair: Josef Niebauer, MD, PhD, MBA, Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): October 31, 2013
• Last Update Submitted That Met QC Criteria: October 30, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Lung Diseases, Obstructive; COPD; Lung Diseases; oxygen; Pulmonary Disease, Chronic Obstructive; Respiration Disorders; oxygen supplementation; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: UISM-4