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Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases

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ClinicalTrials.gov Identifier: NCT06385301
Recruitment Status : Not yet recruiting
First Posted : April 26, 2024
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE April 17, 2024
First Posted Date  ICMJE April 26, 2024
Last Update Posted Date April 26, 2024
Estimated Study Start Date  ICMJE May 2024
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2024)		 6-minute walk distance (6MWD) with supplemental oxygen therapy (SOT) vs. ambient air [ Time Frame: after 6 minutes ]
Change in 6MWD in meter between SOT via nasal cannula vs. ambient air
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2024)
  • SpO2 at rest and peak 6MWD with SOT vs. ambient air [ Time Frame: after 6 minutes ]
    Change of the arterial oxygen saturation by pulse oximetry (SpO2) at rest and at peak 6MWD with SOT vs. ambient air
  • Heart rate at rest and peak 6MWD with SOT vs. ambient air [ Time Frame: after 6 minutes ]
    Change of heart rate (bpm) at rest and at peak 6MWD with SOT vs. ambient air
  • Borg dyspnea scale at rest and peak 6MWD with SOT vs. ambient air [ Time Frame: 6 minutes ]
    Change of Borg dyspnea scale at rest and at peak 6MWD with SOT vs. ambient air
  • Borg leg fatigue scale at rest and peak 6MWD with SOT vs. ambient air [ Time Frame: after 6 minutes ]
    Change of Borg leg fatigue scale at rest and at peak 6MWD with SOT vs. ambient air
  • Blood pressure at rest and peak 6MWD with SOT vs. ambient air [ Time Frame: after 6 minutes ]
    Change of Blood pressure (mmHg) at rest and at peak 6MWD with SOT vs. ambient air
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy With Chronic Lung Diseases
Official Title  ICMJE Exercise Performance on Ambient Air vs. Commonly Prescribed Nasal Low Oxygen Therapy - a Non-Inferiority Trial in Patients With Exercise Induced Desaturation Due to Chronic Lung Diseases
Brief Summary The investigators aim to study the effect of SOT in subjects with chronic lung disease in submaximal exercise.
Detailed Description

Participants with lung disease who live in Switzerland will have 6-minute walk distance (6MWD) test with and without SOT at approximately 3l/min via nasal cannula according to a randomized cross-over design.

The trial aims to test that the 6MWD with SOT is non-inferior to a 6MWD in the same participant under ambient air.

Our effect size was estimated with a difference of less or equal to 35m compared under SOT compared to ambient air.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Each participant is its own control
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Lung Disease Chronic
  • Lung Diseases, Interstitial
  • Lung Diseases, Obstructive
Intervention  ICMJE
  • Other: 6-minute walk distance (6MWD) test on ambient air
    6-minute walk distance (6MWD) test will be performed on ambient air according to clinical standards
  • Other: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)
    6-minute walk distance (6MWD) test will be performed according to clinical standards additionally with supplemental oxygen therapy (approximately 3l/min, nasal)
Study Arms  ICMJE
  • Experimental: Ambient air
    Patient will perform tests at University Hospital Zurich on ambient air
    Intervention: Other: 6-minute walk distance (6MWD) test on ambient air
  • Active Comparator: SOT via basal cannula
    Supplemental Oxygen Therapy (SOT) will be provided via nasal cannula from a small oxygen concentrator while the patient performs tests at University Hospital Zurich.
    Intervention: Other: 6-minute walk distance test with supplemental oxygen (approximately 3l/min, nasal)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 22, 2024)		 14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2025
Estimated Primary Completion Date May 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Minimum 18 years of age
  • Written informed consent
  • Patients with diagnosed chronic lung disease
  • Former desaturation under exercise defined as Spo2-decrease >3%- Page 3 of 4
  • Treated with a stable drug therapy (with no changes for at least 14 days prior to screening)

Exclusion Criteria:

  • Severe hypoxemia needing supplemental oxygen therapy defined as (partial pressure of Oxygen (PaO2) < 6.9 KiloPascal (kPa)
  • Pregnancy
  • Unability or contraindications to undergo the investigated intervention
  • Unability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Silvia Ulrich, Prof. Dr. +41442552220 silvia.ulrich@usz.ch
Contact: Mona Lichtblau, Dr. +41442552220 mona.lichtblau@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06385301
Other Study ID Numbers  ICMJE Lung_disease_6MWD_SOT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be provided upon request and based on a clear intention reviewed by an ethical review board
Current Responsible Party University of Zurich
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Zurich
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvia Ulrich, Prof. Dr. University Hospital Zurich, Department of Pulmonology
PRS Account University of Zurich
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP