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NCT Number: NCT07024914

Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During STST in COPD Patients

It is a randomised, single-blind trial of the effect of acute oxygen supplementation on cerebral oxygenation during the 30 sec Sit-To-Stand Test (STST) in chronic obstructive pulmonary disease patients, without resting hypoxemia. After an initial clinical assessment, patients preform the 30sec STST under near-infrared spectroscopy, a non invasive technique which assesses cerebral oxygenation at the prefrontal lobe. Measurements are performed twice, under oxygen supplementation or medical air, in a random order, and the patients are be blinded to the treatment (oxygen or medical air) given.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Papanikolaou General Hospital

Thessaloniki, 57010, Greece

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical diagnosis of COPD, based on smoking history of at least 100 cigarettes and post bronchodilation forced expiratory volume (FEV1) to forced vital capacity (FVC) ratio <0.7, and 2) resting arterial oxygen partial pressure >60 mmHg, according to recent (within a week) arterial blood gases assessment.

Exclusion criteria

  • recent COPD exacerbation (as indicated by deterioration of respiratory symptoms, hospital admission and/or change in medication within the previous month), 2) history of specific balance problems (i.e., diagnosed neurological or vestibular disorder), 3) spinal surgery, and 4) lower limb musculoskeletal problems (i.e., surgery, injury or pathology at hip, knee, ankle or foot)

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Treatment and study plan

Oxygen

Drug

Oxygen supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia

Medical Air

Drug

Medical Air supplementation via nasal cannula at a rate of 3 lit/min during 30sec Sit-To-Stand Test among COPD patients without resting hypoxemia

Primary outcomes

  1. cerebral oxygenation at the prefrontal lobe

    Time frame: For 2 and a half minutes (one minute of rest, 30 seconds during Sit-To-Stand Test and one minute of recovery after the test)

    Near infrared spectroscopy will be utilised to assess cerebral oxygenation, by measuring oxygenated hemoglobin (O2Hb) at the prefrontal lobe, in COPD patients

Secondary outcomes

  1. Number of repetitions during Sit-To-Stand Test

    Time frame: From the initiation till the end of the Sit-To-Stand Test, that is 30 seconds.

    The number of repetitions (fully standing and sitting) during the Sit-To-Stand Test

  2. Severity of dyspnea

    Time frame: At the end of the 30 second Sit-To-Stand Test

    Rate of dyspnea according to dyspnea Borg scale (0-10)

  3. Severity of fatigue

    Time frame: At the end of the 30 seconds Sit-To-Stand Test

    Score according to Rate of Perceived Exertion

Sponsors and collaborators

Lead sponsor

George Papanicolaou Hospital

Other

Registry information

Official study title

Effect of Oxygen Supplementation on Cerebral Oxygenation, Symptoms and Performance During 30 Sec STST in Chronic Obstructivepulmonary Disease Patients, Without Resting Hypoxemia

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 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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