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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
ClinicalTrials.gov Identifier:
NCT01150383
First received: June 24, 2010
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Other: Physical exercise training with supplemental oxygen
Other: Physical exercise training with "room air supplementation"
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Supplemental Oxygen During Physical Exercise Training on Exercise Capacity in COPD Patients.

Resource links provided by NLM:


Further study details as provided by Paracelsus Medical University:

Primary Outcome Measures:
  • Exercise capacity (Watts/kg) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured by St. George Respiratory Questionnaire

  • Maximal oxygen uptake (VO2-max) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measurement of spiroergometry

  • Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measurement of ergometry

  • BODE-index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    6-minute-walk test

  • Dyspnea [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Measured by BORG-scale

  • Body composition [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Body composition/muscle volume will be measured using magnetic resonance imaging.

  • Blood parameters of inflammation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Inflammatory changes will be assessed via blood test analysis.

  • Vascular changes [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.

  • ten repetition maximum [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.


Enrollment: 50
Study Start Date: July 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group RO (Room air / Oxygen)
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.
Other: Physical 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).

Other Names:
  • training
  • physical training
  • exercise
Active Comparator: group OR (Oxygen / Room air)
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).
Other: Physical 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).

Other Names:
  • training
  • physical training
  • exercise

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150383

Locations
Austria
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, Austria, 5020
Sponsors and Collaborators
Paracelsus Medical University
Investigators
Study Chair: Josef Niebauer, MD, PhD, MBA Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Josef Niebauer M.D., Ph.D., MBA, Prim. Prof. MD, PhD, MBA, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT01150383     History of Changes
Other Study ID Numbers: UISM-4
Study First Received: June 24, 2010
Last Updated: October 30, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Paracelsus Medical University:
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

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014