Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review.
Richard W Bohannon, Rebecca Crouch
https://pubmed.ncbi.nlm.nih.gov/27592691Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07451977
Evaluation of the Effects of Oxygen Supplementation During 6-Minute Walking Test in Patients With Chronic Respiratory Failure or Exertional Hypoxemia
Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2026-04-02
114
Participants Needed
6
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how adding a therapeutic dose of oxygen during exercise affects walking performance, gas exchange, heart rate, symptom perception, and ease of physical activity in patients hospitalized for pulmonary rehabilitation with chronic respiratory failure or exertional hypoxemia due to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD). This multicenter crossover trial aims to better understand appropriate oxygen dosing during exertion and identify patient profiles that may benefit most from this therapy. Participants will perform two 6-minute walk tests in random order: one using their usual oxygen flow prescribed at rest or room air (for those with exertional hypoxemia only), and another with double the resting oxygen flow or 2 liters per minute for those with exertional hypoxemia. Tests will be separated by at least 3 hours and completed within 24 hours. Oxygen is delivered through nasal cannula using standard equipment, with patients carrying their oxygen supply via stroller, backpack, or rollator. During the study, researchers will measure walking distance, oxygen saturation, heart rate, blood pressure, and symptoms such as breathlessness and fatigue before, during, and after each test. Participants will also complete a questionnaire evaluating perceived ease of performance. The main outcome is the difference in walking distance between the two oxygen conditions. This study will help refine oxygen therapy prescriptions during exercise and inform discussions on timing and dosing for patients with respiratory failure.
CONDITIONS
Brief Title
Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation
- Chronic obstructive pulmonary disease with exertional hypoxemia, or
- Chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy, or
- Interstitial lung disease with chronic respiratory failure requiring long-term oxygen therapy
- Clinically stable condition for at least one month
- Optimized medical therapy during hospitalization
- Ability to perform the 6-minute walk test
- Signed informed consent
You will not qualify if you...
- Lung diseases other than chronic obstructive pulmonary disease or interstitial lung disease
- Resting oxygen flow requirement greater than 4 liters per minute
- Orthopedic, neurological, or cognitive conditions that may limit walking performance
- Recent cardiovascular or cerebrovascular events within the previous 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are assessed for diagnosis, clinical stability, and ability to perform the 6-minute walk test.
Treatment
Duration - 1 day
Participants perform two 6-minute walk tests on the same day to compare usual oxygen flow or room air versus supplemental oxygen during exercise.
2 walk test visits on the same day with at least 3 hours between tests
Trial Site Locations
Total: 6 locations
1
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane
Lumezzane, Brescia, Italy, 25065
Actively Recruiting
2
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno
Veruno, Novara, Italy, 28013
Not Yet Recruiting
3
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano
Montescano, Pavia, Italy, 27040
Actively Recruiting
4
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari
Bari, Italy, 70124
Actively Recruiting
5
ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia
Pavia, Italy, 27100
Actively Recruiting
6
Istituti Clinici Maugeri , Respiratory rehabilitation of the Institute of Marina di Ginosa
Taranto, Italy, 74025
Not Yet Recruiting
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Research Team
M
Mara Paneroni, PhD, MSc
T
Tiziana Bachetti, Pharm
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Long-Term Oxygen Treatment Trial Research Group, Richard K Albert, David H Au...
https://pubmed.ncbi.nlm.nih.gov/27783918Ambulatory and short-burst oxygen for interstitial lung disease.
Charles Sharp, Huzaifa Adamali, Ann B Millar
https://pubmed.ncbi.nlm.nih.gov/27383922Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline.
Susan S Jacobs, Jerry A Krishnan, David J Lederer...
https://pubmed.ncbi.nlm.nih.gov/33185464Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial.
Inga Jarosch, Rainer Gloeckl, Eva Damm...
https://pubmed.ncbi.nlm.nih.gov/27940278Short-term ambulatory oxygen for chronic obstructive pulmonary disease.
J M Bradley, B O'Neill
https://pubmed.ncbi.nlm.nih.gov/16235359Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease.
Anne E Holland, Catherine J Hill, Tshepo Rasekaba...
https://pubmed.ncbi.nlm.nih.gov/20159125ATS statement: guidelines for the six-minute walk test.
ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories
https://pubmed.ncbi.nlm.nih.gov/12091180Reliability, repeatability and sensitivity to change of externally and self-paced walking tests in COPD patients.
N Eiser, D Willsher, C J Doré
https://pubmed.ncbi.nlm.nih.gov/12693802