A Six Minute Walking Test Based Index as an Outcome Predictor in COPD Subjects. (Chronic Obstructive Pulmonary Disease)

NCT03799263 | Unknown DMC

• 1 other identifier: 2019001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The six minute walking test (6MWT) is a recognized clinical test to evaluate exercise capacity in different diseases and different conditions. The modalities of performance are described in International Guidelines. The usually reported measure is the distance in meters walked in 6 minutes. Despite the report of a single variable during the test is considered as a limit, changes in monitored variables are seldom analyzed together with the distance walked. In the past there have been some attempts of multifactorial evaluation of 6MWT, however up to date, there is no system considering together the changes of different variables. The investigators wonder whether a multidimensional index based on variables monitored during the 6MWT would better predict 24 month exacerbations and mortality in COPD patients.

Conditions

COPD; Mortality; Disease Exacerbation; Exercise Capacity

Outcome Measures

Primary Outcomes (2)

• COPD Exacerbation

  number of patients with acute exacerbations (treated with antibiotics or steroids)

  24 month

• Mortality

  number of patients died

  24 month

Secondary Outcomes (2)

• hospitalizations

  24 month

• symptoms and anthropometrics characteristics correlation

  24 month

Interventions

evaluation group PROCEDURE

Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable COPD patients assessed for Pulmonary Rehabilitation

You may qualify if:

• COPD diagnosis and grades of severity as assessed by the "old" (I to IV) and "new" (A to D) GOLD guidelines (23)
• Under inhaler therapy for ≥30 days according to guidelines (23)
• Smokers or o ex-smokers, smoke history ≥10 pack/years (p/y)
• Informed Consent Signature.

You may not qualify if:

• Associated Comorbidities with short term severe prognosis
• Actual Cardiac Arrythmias
• Pace-maker
• Other associated respiratory diseases
• Chronic Heart Failure New York Heart Association classes III, IV.
• Use of drugs influencing the heart rate
• Changes in drug therapy in the previous 30 days
• Use of systemic steroids or antibiotics in the previous 30 days
• Unscheduled visits or admission to the Emergency Room for symptoms worsening in the previous 30 days
• Pneumonia during the previous 60 days
• Myocardial Infarction in the previous 4 months
• Subjective and objective inability to perform the 6MWT
• Inability to carry the oxygen cylinder.

Sponsors & Collaborators

• Maugeri Foundation: lead
• Università degli Studi di Sassari: collaborator

Study Sites (1)

Maugeri Foundation

Tradate, VA, 21049, Italy

Location

Related Publications (6)

• Butland RJ, Pang J, Gross ER, Woodcock AA, Geddes DM. Two-, six-, and 12-minute walking tests in respiratory disease. Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8. doi: 10.1136/bmj.284.6329.1607. No abstract available.

  PMID: 6805625 RESULT

• Spruit MA, Watkins ML, Edwards LD, Vestbo J, Calverley PM, Pinto-Plata V, Celli BR, Tal-Singer R, Wouters EF; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study investigators. Determinants of poor 6-min walking distance in patients with COPD: the ECLIPSE cohort. Respir Med. 2010 Jun;104(6):849-57. doi: 10.1016/j.rmed.2009.12.007. Epub 2010 May 14.

  PMID: 20471236 RESULT

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

• Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.

  PMID: 12917227 RESULT

• Rodriguez DA, Kortianou EA, Alison JA, Casas A, Giavedoni S, Barberan-Garcia A, Arbillaga A, Vilaro J, Gimeno-Santos E, Vogiatzis I, Rabinovich R, Roca J. Heart Rate Recovery After 6-min Walking Test Predicts Acute Exacerbation in COPD. Lung. 2017 Aug;195(4):463-467. doi: 10.1007/s00408-017-0027-0. Epub 2017 Jun 17.

  PMID: 28624883 RESULT

• Puhan MA, Mador MJ, Held U, Goldstein R, Guyatt GH, Schunemann HJ. Interpretation of treatment changes in 6-minute walk distance in patients with COPD. Eur Respir J. 2008 Sep;32(3):637-43. doi: 10.1183/09031936.00140507. Epub 2008 Jun 11.

  PMID: 18550610 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Disease Progression

Condition Hierarchy (Ancestors)

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

Study Officials

• Antonio Spanevello, Prof

  Maugeri Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 10, 2019
• Study Start: February 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: December 1, 2023
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

IT (1)