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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-18

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Oxygen

Intervention Type 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 medical air during the 30 sec Sit to Stand Test in patients with COPD

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

Group Type SHAM_COMPARATOR

medical air

Intervention Type 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

Interventions

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Oxygen

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

Intervention Type DRUG

medical air

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

Intervention Type DRUG

Eligibility Criteria

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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)

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Eligible Sex

ALL

Accepts Healthy Volunteers

No