Correction of Exercise-induced Desaturation by Acute Oxygen Supply and Exercise Responses in COPD

NCT02055885 | Completed

• 1 other identifier: Fvie_RePox-1
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 2

Brief Summary

In the literature, the effects of acute oxygen administration on exercise tolerance and related symptoms have often appeared to be contradictory. Some investigations have reported benefits from acute oxygen supply during exertion, including increased exercise performance, reduced dyspnea, and better cardiorespiratory adaptations, whereas other studies have reported no improvement. Recently, we advanced then the hypothesis that some patients would be non-responders and even worsen under oxygen treatment. The preliminary results confirmed our hypothesis since we demonstrated that while 56% of the patients were improved with supplemental oxygen, 16% were non-responders and 28% were negative-responders (decreased performance and increased dyspnea during endurance exercise with supplemental oxygen). However, this was a pilot study offering preliminary insights and tentative conclusions that must be confirmed in a larger case series. The aims of this retrospective study was :

1. 1.To confirm on cohorte and with clinical test (the 6-minute walking test - 6WT) the deleterious responses to acute oxygen supplementation in LTOT (long terme oxygenotherapy treatment) and non-LTOT patients who exhibit exercise desaturation.
2. 2.To identify the predictive factors among the clinical data (i.e., anthropometric, spirometric and gazometric data) and/or functional data recorded during rehabilitation program

Conditions

Chronic Obstructive Pulmonary Disease; Oxygen/Therapeutic Use

Outcome Measures

Primary Outcomes (1)

• Distance of six minute walking test (meter)

  Baseline

Secondary Outcomes (1)

• Dyspnea during the 6 minute walking test

  Baseline

Study Arms (2)

Positive responders

Positive responders (R+): patients exhibiting an increase in the 6WT distance ≥ 10% and/or a decrease in dyspnea ≥ 10% (i.e., ≥ 1 point on the visual analogue scale).

negative responders

Negative responders(R-): patients exhibiting a decrease in the distance ≥ 10% and/or an increase in dyspnea ≥ 10%.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with chronic obstructive pulmonary disease and exhibiting an exercise-induced desaturation during six minute walkink test.

You may qualify if:

• Obstructive airflow limitation defined by FEV1/CVF \< 70% and FEV1 \< 80 %
• Patients with or without long terme oxygenotherapy
• Patients exhibited during the first test, an exercise-induced desaturation, defined by SaO2 \< 90% for 3 consecutive minutes during the 6-minute walking test in the air condition for non-LTOT or with the flow normally recommended during exercise for LTOT patients (i.e., flow rate of rest + 1L/min)
• Patients with no desaturation during the test with oxygen supply

Sponsors & Collaborators

• 5 Santé: lead

Study Sites (2)

Clinique du Souffle La Vallonie

Lodève, 34800, France

Location

Clinique du Souffle La Solane

Osséjà, 66340, France

Location

Related Publications (1)

• Heraud N, Prefaut C, Durand F, Varray A. Does correction of exercise-induced desaturation by O(2) always improve exercise tolerance in COPD? A preliminary study. Respir Med. 2008 Sep;102(9):1276-86. doi: 10.1016/j.rmed.2008.04.005. Epub 2008 Jul 10.

  PMID: 18619828 BACKGROUND

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

• Nelly N HERAUD, Pd-D

  5 Santé

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 8, 2015

Record last verified: 2015-07

Locations

FR (2)