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

N/AActive Not RecruitingNCT07107828

Eastern Switzerland University of Applied Sciences52 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 3 weeks

Secondary Outcomes

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

Analysis of the respiratory signal before and after 6-minute walking distance

Time frame: before and after 6-minute walking distance

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

Analysis of the respiratory signal before and after constant work rate exercise test

Time frame: before and after constant work rate exercise test

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

Analysis of the respiratory signal before and after exercise (6-minute walking distance and constant work rate exercise test), and comparing before and after rehabilitation.

Time frame: 3 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes