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Completed

NCT Number: NCT01150383

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

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise training with supplemental oxygen

Other

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

Physical exercise training with "room air supplementation"

Other

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

Primary outcomes

  1. Exercise capacity (Watts/kg)

    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".

Secondary outcomes

  1. Quality of life

    Time frame: 6 weeks

    Measured by St. George Respiratory Questionnaire

  2. Maximal oxygen uptake (VO2-max)

    Time frame: 6 weeks

    Measurement of spiroergometry

  3. Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.

    Time frame: 6 weeks

    Measurement of ergometry

  4. BODE-index

    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.

  5. Walking capacity

    Time frame: 6 weeks

    6-minute-walk test

  6. Dyspnea

    Time frame: 6 weeks

    Measured by BORG-scale

  7. Body composition

    Time frame: 6 weeks

    Body composition/muscle volume will be measured using magnetic resonance imaging.

  8. Blood parameters of inflammation

    Time frame: 6 weeks

    Inflammatory changes will be assessed via blood test analysis.

  9. Vascular changes

    Time frame: 6 weeks

    Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.

  10. ten repetition maximum

    Time frame: 6 weeks

    The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.

Sponsors and collaborators

Lead sponsor

Paracelsus Medical University

Other

Registry information

Official study title

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

Acronym: SCOPE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2010
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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