Chronic Obstructive Pulmonary DiseasePhase 4SCOPENCT01150383
SCOPE-Study: Salzburg Chronic Obstructive Pulmonary Disease- Exercise and Oxygen Study
A Phase 4 study testing Physical exercise training with supplemental oxygen and Physical exercise training with "room air supplementation" in people with Chronic Obstructive Pulmonary Disease, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Physical exercise training with supplemental oxygen and Physical exercise training with "room air supplementation"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2010to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD with FEV1 pred. 30 to 60%, PO2 at rest > 55 mmHg and PCO2 < 45 mm Hg
- age: > 30 years
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Austria1 site
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
Salzburg, 5020
About this study
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.
Read more
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Physical exercise training with supplemental oxygen, Physical exercise training with "room air supplementation"
- Keywords
- 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
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Respiratory Tract Diseases, Lung Diseases, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise training with supplemental oxygenOther
Also called training, physical training, exercise
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).
Physical exercise training with "room air supplementation"Other
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| group RO (Room air / Oxygen) | Active comparator | 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. Receives: Other: Physical exercise training with "room air supplementation" |
| group OR (Oxygen / Room air) | Active comparator | 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). Receives: Other: Physical exercise training with supplemental oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity (Watts/kg)
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".
Measured: 6 weeks
Secondary outcomes (10)
Quality of life
Measured by St. George Respiratory Questionnaire
Measured: 6 weeks
Maximal oxygen uptake (VO2-max)
Measurement of spiroergometry
Measured: 6 weeks
Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.
Measurement of ergometry
Measured: 6 weeks
BODE-index
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.
Measured: 6 weeks
Walking capacity
6-minute-walk test
Measured: 6 weeks
Dyspnea
Measured by BORG-scale
Measured: 6 weeks
Body composition
Body composition/muscle volume will be measured using magnetic resonance imaging.
Measured: 6 weeks
Blood parameters of inflammation
Inflammatory changes will be assessed via blood test analysis.
Measured: 6 weeks
Vascular changes
Vascular changes will be assessed via blood test analysis as well as analysis of endothelial function.
Measured: 6 weeks
ten repetition maximum
The ten repetition maximum (10-RM) is a measure of the maximal weight a subject can lift 10 times.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
- Investigators
- Josef Niebauer, MD, PhD, MBA, Study chair, Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150383
- Sponsor's protocol ID
- UISM-4
- Acronym
- SCOPE
- Status last verified
- Oct 2013
- First submitted
- 24 Jun 2010
- Last updated
- 31 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vogiatzis I, Athanasopoulos D, Stratakos G, Garagouni C, Koutsoukou A, Boushel R, Roussos C, Zakynthinos S. Exercise-induced skeletal muscle deoxygenation in O-supplemented COPD patients. Scand J Med Sci Sports. 2009 Jun;19(3):364-72. doi: 10.1111/j.1600-0838.2008.00808.x. Epub 2009 May 19.
PubMed 18492053Nonoyama ML, Brooks D, Lacasse Y, Guyatt GH, Goldstein RS. Oxygen therapy during exercise training in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.
PubMed 17443585ZuWallack RL. The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. Respir Care. 2008 Sep;53(9):1190-5.
PubMed 18718038Watz H, Waschki B, Meyer T, Magnussen H. Physical activity in patients with COPD. Eur Respir J. 2009 Feb;33(2):262-72. doi: 10.1183/09031936.00024608. Epub 2008 Nov 14.
PubMed 19010994Puhan MA, Schunemann HJ, Frey M, Scharplatz M, Bachmann LM. How should COPD patients exercise during respiratory rehabilitation? Comparison of exercise modalities and intensities to treat skeletal muscle dysfunction. Thorax. 2005 May;60(5):367-75. doi: 10.1136/thx.2004.033274.
PubMed 15860711Casaburi R, ZuWallack R. Pulmonary rehabilitation for management of chronic obstructive pulmonary disease. N Engl J Med. 2009 Mar 26;360(13):1329-35. doi: 10.1056/NEJMct0804632. No abstract available.
PubMed 19321869Neunhauserer D, Hudelmaier M, Niederseer D, Vecchiato M, Wirth W, Steidle-Kloc E, Kaiser B, Lamprecht B, Ermolao A, Studnicka M, Niebauer J. The Impact of Exercise Training and Supplemental Oxygen on Peripheral Muscles in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Dec 1;55(12):2123-2131. doi: 10.1249/MSS.0000000000003268. Epub 2023 Aug 2.
PubMed 37535316
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplemental Oxygen During Physical Exercise Training on Exercise Capacity in COPD Patients.
- ClinicalTrials.gov ID
- NCT01150383
- Acronym / sponsor ID
- SCOPE / UISM-4
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Lung Diseases, Obstructive, Respiratory Tract Diseases, Lung Diseases, Respiration Disorders, Pulmonary Disease, Chronic Obstructive, COPD, Chronic Obstructive Lung Disease, Chronic Obstructive Airway Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group RO (Room air / Oxygen) | Active comparator | Other: Physical exercise training with "room air supplementation"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. |
| group OR (Oxygen / Room air) | Active comparator | Other: Physical exercise training with supplemental oxygenOR (Oxygen / Room air): First 6 weeks of exercise training with oxygen supplementation, followed by 6 weeks of exercise training under normoxic conditions (room air). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COPD with FEV1 pred. 30 to 60%, PO2 at rest > 55 mmHg and PCO2 < 45 mm Hg
- age: > 30 years
Key exclusion criteria (8 listed)
- 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 %
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise training with supplemental oxygenAlso: training, physical training, exercisePrior 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 | group OR (Oxygen / Room air) |
| Physical exercise training with "room air supplementation"Also: training, physical training, exercisePrior 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 | group RO (Room air / Oxygen) |
Primary outcome
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".
10 secondary outcomes
Quality of life
Time frame: 6 weeks
Maximal oxygen uptake (VO2-max)
Time frame: 6 weeks
Heart rate, blood pressure and exercise capacity at lactate-thresholds 2,3 and 4.
Time frame: 6 weeks
BODE-index
Time frame: 6 weeks
Walking capacity
Time frame: 6 weeks
Dyspnea
Time frame: 6 weeks
Body composition
Time frame: 6 weeks
Blood parameters of inflammation
Time frame: 6 weeks
Vascular changes
Time frame: 6 weeks
ten repetition maximum
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Background: PubMed 18492053Vogiatzis I, Athanasopoulos D, Stratakos G, Garagouni C, Koutsoukou A, Boushel R, Roussos C, Zakynthinos S. Exercise-induced skeletal muscle deoxygenation in O-supplemented COPD patients. Scand J Med Sci Sports. 2009 Jun;19(3):364-72. doi: 10.1111/j.1600-0838.2008.00808.x. Epub 2009 May 19.
- Background: PubMed 17443585Nonoyama ML, Brooks D, Lacasse Y, Guyatt GH, Goldstein RS. Oxygen therapy during exercise training in chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD005372. doi: 10.1002/14651858.CD005372.pub2.
- Background: PubMed 18718038ZuWallack RL. The roles of bronchodilators, supplemental oxygen, and ventilatory assistance in the pulmonary rehabilitation of patients with chronic obstructive pulmonary disease. Respir Care. 2008 Sep;53(9):1190-5.
- Background: PubMed 19010994Watz H, Waschki B, Meyer T, Magnussen H. Physical activity in patients with COPD. Eur Respir J. 2009 Feb;33(2):262-72. doi: 10.1183/09031936.00024608. Epub 2008 Nov 14.
- Background: PubMed 15860711Puhan MA, Schunemann HJ, Frey M, Scharplatz M, Bachmann LM. How should COPD patients exercise during respiratory rehabilitation? Comparison of exercise modalities and intensities to treat skeletal muscle dysfunction. Thorax. 2005 May;60(5):367-75. doi: 10.1136/thx.2004.033274.
- Background: PubMed 19321869Casaburi R, ZuWallack R. Pulmonary rehabilitation for management of chronic obstructive pulmonary disease. N Engl J Med. 2009 Mar 26;360(13):1329-35. doi: 10.1056/NEJMct0804632. No abstract available.
- Derived from this study: PubMed 37535316Neunhauserer D, Hudelmaier M, Niederseer D, Vecchiato M, Wirth W, Steidle-Kloc E, Kaiser B, Lamprecht B, Ermolao A, Studnicka M, Niebauer J. The Impact of Exercise Training and Supplemental Oxygen on Peripheral Muscles in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial. Med Sci Sports Exerc. 2023 Dec 1;55(12):2123-2131. doi: 10.1249/MSS.0000000000003268. Epub 2023 Aug 2.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josef Niebauer, MD, PhD, MBA study chair
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physical exercise training with supplemental oxygen and Physical exercise training with "room air supplementation" in people with Chronic Obstructive Pulmonary Disease, run by Paracelsus Medical University at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity (Watts/kg) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01150383, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.