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

N/AActive Not RecruitingNCT07024914

George Papanicolaou Hospital25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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) \-

Outcomes

Primary Outcomes

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

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)

Secondary Outcomes

Number of repetitions during Sit-To-Stand Test

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

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

Severity of dyspnea

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

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

Severity of fatigue

Score according to Rate of Perceived Exertion

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