Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, 5020, Austria
NCT Number: NCT01150383
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.
Looking for future studies?
Notify Me30 year and older
All sexes
Interventional
Phase 4
Salzburg, 5020, Austria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: training, physical training, exercise
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: training, physical training, exercise
Time frame: 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".
Time frame: 6 weeks
Measured by St. George Respiratory Questionnaire
Time frame: 6 weeks
Measurement of spiroergometry
Time frame: 6 weeks
Measurement of ergometry
Time frame: 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.
Time frame: 6 weeks
6-minute-walk test
Time frame: 6 weeks
Measured by BORG-scale
Time frame: 6 weeks
Body composition/muscle volume will be measured using magnetic resonance imaging.
Time frame: 6 weeks
Inflammatory changes will be assessed via blood test analysis.
Time frame: 6 weeks
Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.
Time frame: 6 weeks
The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.
Paracelsus Medical University
Other
The Effect of Supplemental Oxygen During Physical Exercise Training on Exercise Capacity in COPD Patients.
Acronym: SCOPE
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