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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Physical exercise training with "room air supplementation"; Other: Physical exercise training with supplemental oxygen

• Registration Number: NCT01150383
• Lead Sponsor: Paracelsus Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-25
• Study Start: 2010-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
group RO (Room air / Oxygen)	Physical exercise training with "room air supplementation"	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.
group OR (Oxygen / Room air)	Physical exercise training with supplemental oxygen	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.	6 weeks	Measurement of ergometry
Maximal oxygen uptake (VO2-max)	6 weeks	Measurement of spiroergometry
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
Quality of life	6 weeks	Measured by St. George Respiratory Questionnaire
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.

Trial Locations

Locations (1)

Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg; 🇦🇹 Salzburg, Austria