Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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