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

Paracelsus Medical University (PMU)

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Other: Physical exercise training with supplemental oxygen; Other: Physical exercise training with "room air supplementation"

Study type: Interventional

Funder types: Other

Identifiers

NCT01150383

UISM-4

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

group RO (Room air / Oxygen)

Active Comparator group

Description:

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.

Treatment:

Other: Physical exercise training with "room air supplementation"

group OR (Oxygen / Room air)

Active Comparator group

Description:

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).

Treatment:

Other: Physical exercise training with supplemental oxygen