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

NCT ID: NCT07063563

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normoxia

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

Group Type SHAM_COMPARATOR

ambiant air

Intervention Type OTHER

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

Hyperoxia

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

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type OTHER

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

Hypoxia

This group will train at moderate altitude

Group Type EXPERIMENTAL

ambiant air

Intervention Type OTHER

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

Interventions

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ambiant air

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

Intervention Type OTHER

Oxygen

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

Intervention Type OTHER

ambiant air

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

OTHER_GOV

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Eastern Switzerland University of Applied Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National center for cardiology and internal medicine

Bishkek, Kyrgyzstan, Kyrgyzstan

Site Status RECRUITING

Eastern Switzerland University of Applied Sciences

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status ACTIVE_NOT_RECRUITING

Countries

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Kyrgyzstan Switzerland

Central Contacts

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Stéphanie Saxer, Dr.

Role: CONTACT

+41 58 257 12 97

Facility Contacts

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Talant Sooronbaev, Prof.

Role: primary

Other Identifiers

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inRehaExO2_FOT

Identifier Type: -

Identifier Source: org_study_id

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