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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Physical exercise training with supplemental oxygen
* Other: Physical exercise training with room air supplementation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group RO (Room air / Oxygen)<br>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<br>* 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).<br>* Other names: exercise;|
| Active Comparator: group OR (Oxygen / Room air)<br>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<br>* 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).<br>* Other names: exercise;|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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