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

NCT07024914 | Active Not Recruiting

• 1 other identifier: GeorgePH39/16-01-2019
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• cerebral oxygenation at the prefrontal lobe

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

  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)

Secondary Outcomes (3)

• Number of repetitions during Sit-To-Stand Test

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

• Severity of dyspnea

  At the end of the 30 second Sit-To-Stand Test

• Severity of fatigue

  At the end of the 30 seconds Sit-To-Stand Test

Study Arms (2)

Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD

ACTIVE COMPARATOR

Oxygen supplementation via nasal cannula at a rate of 3 lit/min

Drug: Oxygen

Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD

SHAM COMPARATOR

Medical air supplementation via nasal cannula at a rate of 3 lit/min

Drug: medical air

Interventions

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

Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD

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

Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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)

Sponsors & Collaborators

• George Papanicolaou Hospital: lead

Study Sites (1)

Papanikolaou General Hospital

Thessaloniki, 57010, Greece

Location

Related Links

• Related Info
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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Oxygen; Air

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Pulmonary Medicine

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: September 18, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

GR (1)