Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation

Single Centre, Exploratory, Phase II, Cross-over, Randomised Trial, Evaluating the Effect of Spontaneously Breathing He/O2 65%/35% to Either Spontaneously Breathing N2/O2 65%35% or Non-Invasive Ventilated N2/O2 65%/35% on a 6 Minute Walk Test in Severe COPD Patients

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01355809

Acronym

rehabilitate

Enrollment

Registered

2011-05-18

Start date

2009-12-31

Completion date

2011-05-31

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Six-Minute Walk Test

Brief summary

The purpose of this study is to evaluate effects of inspired gas mixtures on the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test.

Detailed description

the purpose of this study is to evaluate the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test (6MWT) while breathing Helium/Oxygen 65%/35% compared to either breathing Nitrogen/Oxygen 65%/35% or receiving Non-Invasive Ventilation (NIV) with a FiO2 of 0.35 and to evaluate exercise related symptoms

Interventions

DRUGInhalation gas

Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes

DRUGInhalation Nitrogen/Oxygen

Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes

DRUGInhalation Helium/Oxygen

Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Male or female aged \>= 45 and \<= 75 years old * Patient with documented clinical diagnosis of stage III/IV COPD * Patient with stable COPD defined by no significant increase in COPD medication, no treatment for COPD in an emergency, no acute intensive care setting and no intake of antibiotics in the four weeks prior to selection

Exclusion criteria

* Inability or contra-indication to perform pulmonary function tests * Inability or contra-indication to perform the 6MWT with a trolley * Any contra-indication to receive NIV * Obese patient having a Body Mass Index (BMI) \> 35 * Pregnant or lactating woman * Female or chil-bearing potential with lack of efficient contraception

Design outcomes

Primary

Measure	Time frame	Description
Distance walked	6 minutes	evaluate the distance walked by patients during a Six-Minute Walk Test

Secondary

Measure	Time frame	Description
Assessment of the safety of inhalation Helium/Oxygen	6 minutes	evaluate the safety of the administration of Helium/Oxygen 65%/35%

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026