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

NCT07107828 | Active Not Recruiting

• 1 other identifier: inRehaExO2_Respeck
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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)

Keywords

Rehabilitation; Exercise; Oxygen; Breathing

Outcome Measures

Primary Outcomes (1)

• Comparison of respiratory rate (in terms of breaths/minute)

  The longitudinal analysis of features extracted from the continuous Respeck respiratory flow/effort signals pre and post the 3-week in-house rehabilitation programme, and comparisons between the different groups.

  3 weeks

Secondary Outcomes (3)

• Comparison of respiratory rate (in terms of breaths/minute)

  before and after 6-minute walking distance

• Comparison of respiratory rate (in terms of breaths/minute)

  before and after constant work rate exercise test

• Comparison of respiratory rate (in terms of breaths/minute)

  3 weeks

Study Arms (3)

Normoxia

SHAM COMPARATOR

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

Other: Ambient air

Hyperoxia

ACTIVE COMPARATOR

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

Other: Oxygen

Hypoxia

EXPERIMENTAL

This group will train at moderate altitude

Other: Altitude

Interventions

Ambient air OTHER

Standard ambient air will be breathed during endurance training.

Normoxia

Oxygen OTHER

SSOT will be applied during endurance training

Hyperoxia

Altitude OTHER

Training will be performed at moderate altitude

Hypoxia

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National center for cardiology and internal medicine

Bishkek, Kyrgyzstan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Respiratory Aspiration

Interventions

Particulate Matter; Oxygen; Altitude

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complex Mixtures; Chalcogens; Elements; Inorganic Chemicals; Gases; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

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 16, 2025
• First Posted: August 6, 2025
• Study Start: July 23, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KY (1)