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

Eastern Switzerland University of Applied Sciences

Status: Active, not recruiting

Conditions: COPD (Chronic Obstructive Pulmonary Disease)

Treatments: Other: Oxygen; Other: Ambient air; Other: Altitude

Study type: Interventional

Funder types: Other

Identifiers

NCT07107828

inRehaExO2_Respeck

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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52 participants in 3 patient groups

Normoxia

Sham Comparator group

Description:

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

Treatment:

Other: Ambient air

Hyperoxia

Active Comparator group

Description:

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

Treatment:

Other: Oxygen

Hypoxia

Experimental group

Description:

This group will train at moderate altitude

Treatment:

Other: Altitude