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Active, Not Recruiting

NCT Number: NCT07044843

Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?

The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.

The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

COPD Behavior Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

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

Loading trial locations.

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

Oxygen

Other

SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training

Standard ambiant air will be breathed during endurance training.

Other

ambiant air

Primary outcomes

  1. Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia

    Time frame: from baseline to 3 weeks

Secondary outcomes

  1. 6 minute walk test (6MWT)

    Time frame: 3 weeks

    6 minute walk distance (6MWD), SpO2 and heart rate at the end of the 6 minute walk test (6MWT) from baseline to 3 weeks at normoxia vs hypoxia vs hyperoxia

  2. Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia

    Time frame: 3 weeks

    HADS-A (Anxiety): 7 items

    HADS-D (Depression): 7 items

    Each item is scored from 0 to 3, resulting in:

    Minimum score per subscale: 0

    Maximum score per subscale: 21

    Interpretation:

    Higher scores indicate worse psychological status.

    Scores of 0-7: Normal

    Scores of 8-10: Borderline abnormal

    Scores of 11-21: Abnormal (clinically relevant anxiety or depression)

  3. mMRC score at normoxia vs hypoxia vs hyperoxia

    Time frame: 3 weeks

    The scale ranges from 0 to 4.

    Each grade reflects a different level of functional limitation due to dyspnea.

    Minimum score: 0 Maximum score: 4

    Interpretation:

    Higher scores indicate more severe dyspnea (worse outcome).

  4. CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia

    Time frame: 3 weeks

    It consists of 8 items, each scored from 0 to 5.

    The total score ranges from:

    Minimum score: 0 Maximum score: 40

    Interpretation:

    Higher scores indicate greater symptom burden and worse health status.

    Score bands for interpretation:

    0-10: Low impact

    11-20: Medium impact

    21-30: High impact

    31-40: Very high impact

  5. Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia

    Time frame: 3 weeks

    The CRQ consists of 20 items across four domains:

    Dyspnea (5 items)

    Fatigue (4 items)

    Emotional function (7 items)

    Mastery (4 items)

    Each item is scored on a 7-point Likert scale:

    Minimum score per item: 1

    Maximum score per item: 7

    Interpretation:

    Higher scores indicate better health-related quality of life (less impairment).

    Mean scores are calculated per domain and as a total score.

  6. Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia

    Time frame: 3 months

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 Zurich

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Aug 7, 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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