COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
Rehabilitation, Exercise, Oxygen, Breathing
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.
Interventions
OTHERAmbient air
Standard ambient air will be breathed during endurance training.
OTHEROxygen
SSOT will be applied during endurance training
OTHERAltitude
Training will be performed at moderate altitude
Sponsors
Eastern Switzerland University of Applied Sciences
University of Edinburgh
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of respiratory rate (in terms of breaths/minute) | 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of respiratory rate (in terms of breaths/minute) | before and after 6-minute walking distance | Analysis of the respiratory signal before and after 6-minute walking distance |
Countries
Kyrgyzstan
Outcome results
None listed