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NCT Number: NCT07107828

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National center for cardiology and internal medicine

Bishkek, Kyrgyzstan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ambient air

Other

Standard ambient air will be breathed during endurance training.

Oxygen

Other

SSOT will be applied during endurance training

Altitude

Other

Training will be performed at moderate altitude

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: before and after 6-minute walking distance

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

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

    Time frame: before and after constant work rate exercise test

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

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

    Time frame: 3 weeks

    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.

Sponsors and collaborators

Lead sponsor

Eastern Switzerland University of Applied Sciences

Other

Collaborators

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

Registry information

Official study title

Effect of Rehabilitation on the Respiratory Signal in Patients With Chronic Obstrucitve Pulmonary Disease (COPD) and Exercise-Induced Desaturation

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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