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

NCT01150383 | Completed Phase 4

• 1 other identifier: UISM-4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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; Chronic Airflow Obstruction; oxygen; oxygen supplementation

Outcome Measures

Primary Outcomes (1)

• 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".

  6 weeks

Secondary Outcomes (10)

• Quality of life

  6 weeks

• Maximal oxygen uptake (VO2-max)

  6 weeks

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

  6 weeks

• BODE-index

  6 weeks

• Walking capacity

  6 weeks

Study Arms (2)

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.

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).

Other: Physical exercise training with supplemental oxygen

Interventions

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).

Also known as: training, physical training, exercise

group OR (Oxygen / Room air)

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).

Also known as: training, physical training, exercise

group RO (Room air / Oxygen)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD with FEV1 pred. 30 to 60%, PO2 at rest \> 55 mmHg and PCO2 \< 45 mm Hg
• age: \> 30 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Paracelsus Medical University: lead

Study Sites (1)

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

Salzburg, 5020, Austria

Location

Related Publications (7)

• 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.

  PMID: 18492053 BACKGROUND

• Nonoyama 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.

  PMID: 17443585 BACKGROUND

• ZuWallack 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.

  PMID: 18718038 BACKGROUND

• Watz 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.

  PMID: 19010994 BACKGROUND

• Puhan 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.

  PMID: 15860711 BACKGROUND

• Casaburi 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.

  PMID: 19321869 BACKGROUND

• Neunhauserer 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.

  PMID: 37535316 DERIVED

Related Links

• Related Info
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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders

Interventions

Physical Conditioning, Human; Exercise

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Josef Niebauer, MD, PhD, MBA

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prim. Prof. MD, PhD, MBA

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

AU (1)