Effect of Rehabilitation at Moderate Altitude on Airway Resistance Measured With Forced Oscillation Technique in COPD-patients

NCT07063563 | Recruiting

• 1 other identifier: inRehaExO2_FOT
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

Brief Summary

Airway resistance will be measured using the forced oscillation technique (FOT). The parameters Rrs, Xrs, and ∆Xrs will be compared before and after a pulmonary rehabilitation cycle at moderate altitude. Additionally, the differences between low and moderate altitude will also be examined.

Conditions

COPD

Keywords

Oxygen; Exercise; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 1. Change in Rrs (Respiratory System Resistance) before and after rehabilitation cycle

  Rrs will be measured using the forced oscillation technique (FOT) in cmH₂O·s/L. Values will be assessed before and after the pulmonary rehabilitation cycle at moderate altitude

  baseline to 3 weeks

Secondary Outcomes (3)

• Change in Xrs (Respiratory System Reactance) compared before and after the pulmonary rehabilitation.

  baseline to 3 weeks

• Change in ∆Xrs (Difference in Reactance) before and after rehabilitation

  baseline to 3 weeks

• Change in Rrs, Xrs and ∆Xrs from low to moderate altitude

  From baseline at low altitude to transfer to moderate altitude at 3 days

Study Arms (3)

Normoxia

SHAM COMPARATOR

Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFlo TM via nasal cannula

Other: ambiant air

Hyperoxia

ACTIVE COMPARATOR

Standardized supplemental oxygen therapy (SSOT) at 5 L/min will be delivered using the EverFlo™ oxygen concentrator via nasal cannula during training.

Other: Oxygen

Hypoxia

EXPERIMENTAL

This group will train at moderate altitude

Other: ambiant air

Interventions

ambiant air OTHER

Standard ambiant air will be breathed during endurance training. ambiant air

Hypoxia

Oxygen OTHER

SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training

Hyperoxia

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years
• Stable clinical condition for \>3 weeks (e.g., no exacerbations)
• Resting SpO₂ ≥88% and exercise-induced hypoxemia defined as a drop in SpO₂ of ≥4% and/or a level below 90% during the 6MWT
• Informed consent documented by signature

You may not qualify if:

• Severe daytime resting hypoxemia (SpO₂ \<88%)
• Long-term oxygen therapy
• Unstable clinical condition requiring adjustment of pharmacological or other treatment modalities, need for intensive care, or presence of relevant severe comorbidities
• Inability to comply with study procedures (e.g., due to language barriers, psychological disorders, neurological or orthopedic impairments, walking disability, or inability to ride a bicycle)
• Women who are pregnant or breastfeeding
• Enrolment in another clinical trial involving active treatment

Sponsors & Collaborators

• Eastern Switzerland University of Applied Sciences: lead
• National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov: collaborator
• University of Zurich: collaborator

Study Sites (2)

National center for cardiology and internal medicine

Bishkek, Kyrgyzstan, Kyrgyzstan

RECRUITING

Eastern Switzerland University of Applied Sciences

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Oxygen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Central Study Contacts

Stéphanie Saxer, Dr.

CONTACT

+41 58 257 12 97; stephanie.saxer@ost.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: July 23, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); KY (1)