Comparison of the Two and Six- Minute Walk Tests in Evaluating Oxygen Desaturation in Patients With Severe COPD

NCT02462343 | Completed

• 1 other identifier: walk test trial
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

All measurements are performed on two consecutive days at the beginning of a pulmonary rehabilitation program in a randomized cross-over study design. On the first day, each patient is randomly assigned to perform either the 2 minute walk test or the 6 Minute walk test. On the second day each patient performs the test that was not performed on the first day. All walk tests are performed by the same investigator on the same track and time of day, following the 2002 guidelines of the American Thoracic Society. Patients wear a mobile pulse oximeter that continuously records heart rate and oxygen saturation during testing. Baseline values of oxygen saturation, heart rate and ratings of perceived exertion on the modified Borg scale (0 to 10) for dyspnea and leg fatigue are recorded at rest after 10 minutes of sitting.

Conditions

Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (1)

• oxygen desaturation

  up to 6 minute walk test

Secondary Outcomes (2)

• heart rate

  during 2 minute walk test and 6 minute walk test

• perceived exertion for dyspnea and leg fatigue

  during 2 minute walk test and 6 minute walk test

Study Arms (2)

2 minute walk test

OTHER

Other: walk tests

6 minute walk test

OTHER

Other: walk tests

Interventions

walk tests OTHER

2 minute walk test; 6 minute walk test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of chronic obstructive lung disease stage III or IV according to the Global Initiative for chronic Obstructive Lung Diseases definition
• ability to read and understand the German language and study procedures.
• written informed consent

You may not qualify if:

• severe acute exacerbation of chronic obstructive lung disease
• severe respiratory failure (partial Oxygen pressure at rest lower than 55 millimeter mercury)
• non compliance to the study protocol.

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Klaus Kenn, MD

  Schoen Klinik Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 2, 2015
• First Posted: June 4, 2015
• Study Start: March 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: August 1, 2007
• Last Updated: June 4, 2015

Record last verified: 2015-06