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

Not Applicable

Active, not recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Oxygen; Drug: medical air

• Registration Number: NCT07024914
• Lead Sponsor: George Papanicolaou Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-18
• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-09
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. 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

1. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supplementation of oxygen during the 30 sec Sit to Stand Test in patients with COPD	Oxygen	Oxygen supplementation via nasal cannula at a rate of 3 lit/min
Supplementation of medical air during the 30 sec Sit to Stand Test in patients with COPD	medical air	Medical air supplementation via nasal cannula at a rate of 3 lit/min

Primary Outcome Measures

Name	Time	Method
cerebral oxygenation at the prefrontal lobe	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 Outcome Measures

Name	Time	Method
Number of repetitions during Sit-To-Stand Test	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
Severity of dyspnea	At the end of the 30 second Sit-To-Stand Test	Rate of dyspnea according to dyspnea Borg scale (0-10)
Severity of fatigue	At the end of the 30 seconds Sit-To-Stand Test	Score according to Rate of Perceived Exertion

Trial Locations

Locations (1)

Papanikolaou General Hospital; 🇬🇷 Thessaloniki, Greece