Effect of Rehabilitation on the Respiratory Signal in Patients With COPD and Exercise-Induced Desaturation

NCT ID: NCT07107828

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: ACTIVE_NOT_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

The aim is to study the effect of SSOT during a 3-week in-patient pulmonary rehabilitation programme. Further aim is to analyse exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions, during in-patient pulmonary rehabilitation.

The objective of the main study is to provide long-awaited data concerning the use of SSOT during training. At present it is unclear whether patients with chronic lung diseases who reveal an SpO2 > 88% at rest, but desaturate during exercise, and, thus, may not qualify for long-term oxygen undergoing PR benefit from supplemental oxygen.

This sub-study will involve the subjects wearing the Respeck device and will focus on the effect of exercise on the respiratory signal measured by the Respeck.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Normoxia

Sham air (ambient air) will be applied with the oxygen concentrator EverFloTM via nasal cannula

Group Type: SHAM_COMPARATOR

Ambient air

Intervention Type: OTHER

Standard ambient air will be breathed during endurance training.

Hyperoxia

Standardized supplemental oxygen (SSOT) will be applied with the oxygen concentrator EverFloTM via nasal cannula

Group Type: ACTIVE_COMPARATOR

Oxygen

Intervention Type: OTHER

SSOT will be applied during endurance training

Hypoxia

This group will train at moderate altitude

Group Type: EXPERIMENTAL

Altitude

Intervention Type: OTHER

Training will be performed at moderate altitude

Interventions

Ambient air

Standard ambient air will be breathed during endurance training.

Intervention Type: OTHER

Oxygen

SSOT will be applied during endurance training

Intervention Type: OTHER

Altitude

Training will be performed at moderate altitude

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• aged ≥ 18 years
• stable condition > 3 weeks (e.g. no exacerbations)
• resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (6MWT)
• informed consent as documented by signature.

Exclusion Criteria

• Severe daytime resting hypoxemia (SpO2 < 88%)
• long-term oxygen therapy
• unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease
• inability to follow the procedures of the study, e.g. due to language problems psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle
• women who are pregnant or breast feeding
• enrolment in another clinical trial with active treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Edinburgh

OTHER

Sponsor Role: collaborator

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

OTHER_GOV

Sponsor Role: collaborator

Eastern Switzerland University of Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National center for cardiology and internal medicine

Bishkek, , Kyrgyzstan

Countries

Kyrgyzstan

Other Identifiers

inRehaExO2_Respeck

Identifier Type: -

Identifier Source: org_study_id