Chronic Obstructive Pulmonary Disease
Conditions
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
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.
Interventions
OTHERPhysical 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).
OTHERPhysical 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).
Sponsors
Paracelsus Medical University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Maximal oxygen uptake (VO2-max) | 6 weeks | Measurement of spiroergometry |
| Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4. | 6 weeks | Measurement of ergometry |
| 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 |
| 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. |
| Dyspnea | 6 weeks | Measured by BORG-scale |
Countries
Austria
Outcome results
None listed