Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia

NCT07451977 | Recruiting

• 1 other identifier: CET6L 2025-3.11/622
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this multicenter crossover trial is to describe the effect of adding a therapeutic dose of exertional oxygen therapy, in terms of exercise performance, gas exchange, heart rate, symptoms perception and subjective easiness of performance, in a cohort of subjects hospitalized in specialized pulmonary rehabilitation centers with a diagnosis of chronic respiratory failure and/or exertional hypoxemia due to chronic obstructive pulmonary disease or interstitial lung disease. Researchers will compare the walking performance during 6-minute walk test performed with the liters of oxygen administered as prescribed at rest (for patients with chronic respiratory failure) or in room air (for patients with exertional hypoxemia only), to the performance during a 6-minute walk test performed with the double the flow rate prescribed at rest, or with 2 L/min for patients with exertional hypoxemia only. The two tests will be performed in random order, at least 3 hours apart and no later than 24 hours apart from each other. The main outcome will be the difference between the distance walked in the two 6-minute walk test in the two conditions. Furthermore, will be also collected and compared: the oxygen saturation and heart rate every minute, the initial and final dyspnea and fatigue, as assessed by Borg scale, and the easiness of performance through a dedicated questionnaire. The estimated sample size will be 114 patients. This study will provide some basis for a more accurate prescription of exercise-related oxygen therapy, offering insights into the phenotype of patients who may derive the greatest benefit from this intervention. It will also stimulate discussion regarding the optimal timing and dosing of oxygen administration during exertion in patients with respiratory failure.

Conditions

Chronic Respiratory Failure; Hypoxemia; Chronic Obstructive Pulmonary Disease (COPD); Interstitial Lung Disease

Keywords

oxygen supplementation; 6-minute walk test; chronic respiratory failure; exertional hypoxemia; pulmonary rehabilitation; exercise tolerance

Outcome Measures

Primary Outcomes (1)

• Change in 6-Minute Walk Distance With Supplemental Oxygen

  This outcome measures the difference in walking distance during the 6-minute walk test when participants use supplemental oxygen (O2PLUS) compared to their usual oxygen setting or room air (O2REST). The change is calculated as the distance walked with supplemental oxygen minus the distance walked with usual oxygen or room air. This outcome reflects the short-term effect of supplemental oxygen on exercise performance.

  Within 24 hours (during two 6-minute walk tests performed on the same day)

Secondary Outcomes (5)

• Oxygen Saturation During the 6-Minute Walk Test

  During each 6-minute walk test

• Heart Rate During the 6-Minute Walk Test

  During each 6-minute walk test

• Dyspnea Before and After the 6-Minute Walk Test

  Before the test, immediately after the test, and 3 minutes after recovery

• Muscles Fatigue Before and After the 6-Minute Walk Test

  Before the test, immediately after the test, and 3 minutes after recovery

• Blood Pressure Before and After the 6-Minute Walk Test

  Before and immediately after each 6-minute walk test

Other Outcomes (1)

• Participant-Reported Perception of Walking Performance

  Immediately after completion of the second 6-minute walk test

Study Arms (2)

6-Minute Walk Test With Usual Oxygen or Room Air (O2REST)

ACTIVE COMPARATOR

All participants perform the 6-minute walk test with standard oxygen flow (or room air for participants with exertional hypoxemia only). This arm represents the standard condition for comparison. The test may be administered as first or second test, in a random order, according to the crossover design.

Other: Usual Oxygen During 6-Minute Walk Test

6-Minute Walk Test With Supplemental Oxygen (O2PLUS)

EXPERIMENTAL

All participants perform the 6-minute walk test using a higher oxygen flow during exercise to evaluate the effects of supplemental oxygen on walking performance and symptoms. The test may be administered as first or second test, in a random order, according to the crossover design.

Other: Supplemental Oxygen During 6-Minute Walk Test

Interventions

Usual Oxygen During 6-Minute Walk Test OTHER

Participants perform the 6-minute walk test using the oxygen flow prescribed at rest for chronic respiratory failure, or room air for participants with exertional hypoxemia only. Oxygen is delivered through nasal cannula using standard equipment. Walking distance, oxygen saturation, heart rate, and symptoms are recorded during the test.

6-Minute Walk Test With Usual Oxygen or Room Air (O2REST)

Supplemental Oxygen During 6-Minute Walk Test OTHER

Participants perform the 6-minute walk test using supplemental oxygen during exercise. Oxygen flow is set at double the resting prescription for participants with chronic respiratory failure, or at two liters per minute for participants with exertional hypoxemia. Oxygen is delivered through nasal cannula using standard equipment. Walking distance, oxygen saturation, heart rate, and symptoms are recorded during the test.

6-Minute Walk Test With Supplemental Oxygen (O2PLUS)

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Diagnosis of chronic respiratory disease admitted for pulmonary rehabilitation
• One of the following conditions at discharge:
• Chronic obstructive pulmonary disease with exertional hypoxemia
• Chronic obstructive pulmonary disease with chronic respiratory failure requiring long-term oxygen therapy
• 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 may not qualify if:

• 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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (6)

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

Lumezzane, Brescia, 25065, Italy

RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Veruno

Veruno, Novara, 28013, Italy

NOT YET RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Montescano

Montescano, Pavia, 27040, Italy

RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Bari

Bari, 70124, Italy

RECRUITING

ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Pavia

Pavia, 27100, Italy

RECRUITING

Istituti Clinici Maugeri , Respiratory rehabilitation of the Institute of Marina di Ginosa

Taranto, 74025, Italy

NOT YET RECRUITING

Related Publications (19)

• Bohannon RW, Crouch R. Minimal clinically important difference for change in 6-minute walk test distance of adults with pathology: a systematic review. J Eval Clin Pract. 2017 Apr;23(2):377-381. doi: 10.1111/jep.12629. Epub 2016 Sep 4.

  PMID: 27592691 BACKGROUND

• Nishiyama O, Miyajima H, Fukai Y, Yamazaki R, Satoh R, Yamagata T, Sano H, Iwanaga T, Higashimoto Y, Nakajima H, Kume H, Tohda Y. Effect of ambulatory oxygen on exertional dyspnea in IPF patients without resting hypoxemia. Respir Med. 2013 Aug;107(8):1241-6. doi: 10.1016/j.rmed.2013.05.015. Epub 2013 Jun 25.

  PMID: 23806287 BACKGROUND

• Long-Term Oxygen Treatment Trial Research Group; Albert RK, Au DH, Blackford AL, Casaburi R, Cooper JA Jr, Criner GJ, Diaz P, Fuhlbrigge AL, Gay SE, Kanner RE, MacIntyre N, Martinez FJ, Panos RJ, Piantadosi S, Sciurba F, Shade D, Stibolt T, Stoller JK, Wise R, Yusen RD, Tonascia J, Sternberg AL, Bailey W. A Randomized Trial of Long-Term Oxygen for COPD with Moderate Desaturation. N Engl J Med. 2016 Oct 27;375(17):1617-1627. doi: 10.1056/NEJMoa1604344.

  PMID: 27783918 BACKGROUND

• Sharp C, Adamali H, Millar AB. Ambulatory and short-burst oxygen for interstitial lung disease. Cochrane Database Syst Rev. 2016 Jul 6;7(7):CD011716. doi: 10.1002/14651858.CD011716.pub2.

  PMID: 27383922 BACKGROUND

• Jacobs SS, Krishnan JA, Lederer DJ, Ghazipura M, Hossain T, Tan AM, Carlin B, Drummond MB, Ekstrom M, Garvey C, Graney BA, Jackson B, Kallstrom T, Knight SL, Lindell K, Prieto-Centurion V, Renzoni EA, Ryerson CJ, Schneidman A, Swigris J, Upson D, Holland AE. Home Oxygen Therapy for Adults with Chronic Lung Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Nov 15;202(10):e121-e141. doi: 10.1164/rccm.202009-3608ST.

  PMID: 33185464 BACKGROUND

• Jarosch I, Gloeckl R, Damm E, Schwedhelm AL, Buhrow D, Jerrentrup A, Spruit MA, Kenn K. Short-term Effects of Supplemental Oxygen on 6-Min Walk Test Outcomes in Patients With COPD: A Randomized, Placebo-Controlled, Single-blind, Crossover Trial. Chest. 2017 Apr;151(4):795-803. doi: 10.1016/j.chest.2016.11.044. Epub 2016 Dec 8.

  PMID: 27940278 BACKGROUND

• Bradley JM, O'Neill B. Short-term ambulatory oxygen for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD004356. doi: 10.1002/14651858.CD004356.pub3.

  PMID: 16235359 BACKGROUND

• Holland AE, Hill CJ, Rasekaba T, Lee A, Naughton MT, McDonald CF. Updating the minimal important difference for six-minute walk distance in patients with chronic obstructive pulmonary disease. Arch Phys Med Rehabil. 2010 Feb;91(2):221-5. doi: 10.1016/j.apmr.2009.10.017.

  PMID: 20159125 BACKGROUND

• 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 BACKGROUND

• Eiser N, Willsher D, Dore CJ. Reliability, repeatability and sensitivity to change of externally and self-paced walking tests in COPD patients. Respir Med. 2003 Apr;97(4):407-14. doi: 10.1053/rmed.2002.1462.

  PMID: 12693802 BACKGROUND

• Troosters T, Vilaro J, Rabinovich R, Casas A, Barbera JA, Rodriguez-Roisin R, Roca J. Physiological responses to the 6-min walk test in patients with chronic obstructive pulmonary disease. Eur Respir J. 2002 Sep;20(3):564-9. doi: 10.1183/09031936.02.02092001.

  PMID: 12358329 BACKGROUND

• Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

  PMID: 1494764 BACKGROUND

• Revill SM, Morgan MD, Singh SJ, Williams J, Hardman AE. The endurance shuttle walk: a new field test for the assessment of endurance capacity in chronic obstructive pulmonary disease. Thorax. 1999 Mar;54(3):213-22. doi: 10.1136/thx.54.3.213.

  PMID: 10325896 BACKGROUND

• Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

  PMID: 25359355 BACKGROUND

• Hardinge M, Annandale J, Bourne S, Cooper B, Evans A, Freeman D, Green A, Hippolyte S, Knowles V, MacNee W, McDonnell L, Pye K, Suntharalingam J, Vora V, Wilkinson T; British Thoracic Society Home Oxygen Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guidelines for home oxygen use in adults. Thorax. 2015 Jun;70 Suppl 1:i1-43. doi: 10.1136/thoraxjnl-2015-206865.

  PMID: 25870317 BACKGROUND

• Jolly EC, Di Boscio V, Aguirre L, Luna CM, Berensztein S, Gene RJ. Effects of supplemental oxygen during activity in patients with advanced COPD without severe resting hypoxemia. Chest. 2001 Aug;120(2):437-43. doi: 10.1378/chest.120.2.437.

  PMID: 11502641 BACKGROUND

• Emtner M, Porszasz J, Burns M, Somfay A, Casaburi R. Benefits of supplemental oxygen in exercise training in nonhypoxemic chronic obstructive pulmonary disease patients. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1034-42. doi: 10.1164/rccm.200212-1525OC. Epub 2003 Jul 17.

  PMID: 12869359 BACKGROUND

• Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

  PMID: 6110912 BACKGROUND

• Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.

  PMID: 6776858 BACKGROUND

MeSH Terms

Conditions

Hypoxia; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

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

Study Officials

• Mara Paneroni, PhD, MSc

  ICS Maugeri IRCCS, Respiratory rehabilitation of the Institute of Lumezzane

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mara Paneroni, PhD, MSc

CONTACT

+39 030 8253; mara.paneroni@icsmaugeri.it

Tiziana Bachetti, Pharm

CONTACT

0382593; tiziana.bachetti@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-over multicenter randomized study At enrolment (the time of discharge), after obtaining informed consent, patients will perform the 6-Minute Walking Test twice in a random order. The three groups of patients with different diseases will be enrolled at ICSM consecutively within their group, with three different lists of randomisation using blocks of four.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 5, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)