COPD Clinical Trial
— OxyfatigueOfficial title:
Acute Effects of Oxygen Administration on Neuromuscular Fatigue in Chronic Obstructive Pulmonary Disease Patients With Chronic Respiratory Failure and Long-term Oxygen Therapy
The literature on the physiological response (vasodilation, neuromuscular fatigue, and muscle oxygenation) following the application of different dosages of oxygen therapy in patients with Chronic Respiratory Failure (CRF) and Long-Term Oxygen Therapy (LTOT) during exercise is scant. The evaluation of these aspects can allow the clinicians and the rehabilitation staff to correctly dose the oxygen therapy at rest and during exercise and to reach a higher level of improvement after training. For this purpose, we will recruit 20 patients admitted to the Pulmonary Unit of the ICS Maugeri in Lumezzane (BS) with the presence of CRF defined as PaO2 at room air less than 60 mmHg, the need for LTOT since 3 months, and with a stable clinical condition. This is a crossover study and will last 3 days. We will test the same subject, randomly, in the following three conditions: A) CONDITION ROOM AIR: patient will breathe room air through the Venturi mask (Vmask FiO2 21%) and will be considered as "sham condition" B) CONDITION FiO2 30%: the subject will breathe through a Venturi mask with a FiO2 of 30%. C) CONDITION FiO2 60%: the subject will breathe through a Venturi mask with a FiO2 of 60%. During each condition, we will evaluate: a) oxygen saturation (SatO2), transcutaneous paCO2 value (tcCO2), BORG fatigue and dyspnea, blood gas analysis; b) mitochondrial function through the Near Infra-Red Spectroscopy and c) vascular function by Single Passive Leg Movement (sPLM) technique; d) central and peripheral neuromuscular fatigue after a submaximal intermittent isometric contraction. The present project will help to understand the best doses of oxygen therapy to allow patients to achieve a higher level of vasodilation and mitochondrial function and a lower level of neuromuscular fatigue. We could apply these results to the rehabilitation program in order to get a greater level of improvement in exercise tolerance.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2024 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 85 Years |
Eligibility | Inclusion Criteria: - PaO2 in room air less than 60 mmHg assessed by arterial blood gas analysis - FEV1/FVC <70% - FEV1 < 50% of predicted - need for LTOT for 3 months - important non-comorbidities Exclusion Criteria: - Presence of lung diseases other than COPD, respiratory tract infections in the last 4 weeks, terminality, severe neurological and cardiologic comorbidities. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituti Clinici Scientifici Maugeri IRCCS | Lumezzane | Brescia |
Lead Sponsor | Collaborator |
---|---|
Istituti Clinici Scientifici Maugeri SpA | Universita di Verona |
Italy,
Amann M, Romer LM, Subudhi AW, Pegelow DF, Dempsey JA. Severity of arterial hypoxaemia affects the relative contributions of peripheral muscle fatigue to exercise performance in healthy humans. J Physiol. 2007 May 15;581(Pt 1):389-403. doi: 10.1113/jphysiol.2007.129700. Epub 2007 Feb 22. — View Citation
Charususin N, Dacha S, Gosselink R, Decramer M, Von Leupoldt A, Reijnders T, Louvaris Z, Langer D. Respiratory muscle function and exercise limitation in patients with chronic obstructive pulmonary disease: a review. Expert Rev Respir Med. 2018 Jan;12(1):67-79. doi: 10.1080/17476348.2018.1398084. Epub 2017 Nov 6. — View Citation
Emtner M, Porszasz J, Burns M, Somfay A, Casaburi R. Benefits of supplemental oxygen in exercise training in nonhypoxemic chronic obstructive pulmonary disease patients. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1034-42. doi: 10.1164/rccm.200212-1525OC. Epub 2003 Jul 17. — View Citation
Gifford JR, Richardson RS. CORP: Ultrasound assessment of vascular function with the passive leg movement technique. J Appl Physiol (1985). 2017 Dec 1;123(6):1708-1720. doi: 10.1152/japplphysiol.00557.2017. Epub 2017 Sep 7. — View Citation
MERTON PA. Voluntary strength and fatigue. J Physiol. 1954 Mar 29;123(3):553-64. doi: 10.1113/jphysiol.1954.sp005070. No abstract available. — View Citation
Mirza S, Clay RD, Koslow MA, Scanlon PD. COPD Guidelines: A Review of the 2018 GOLD Report. Mayo Clin Proc. 2018 Oct;93(10):1488-1502. doi: 10.1016/j.mayocp.2018.05.026. — View Citation
Rooyackers JM, Dekhuijzen PN, Van Herwaarden CL, Folgering HT. Training with supplemental oxygen in patients with COPD and hypoxaemia at peak exercise. Eur Respir J. 1997 Jun;10(6):1278-84. doi: 10.1183/09031936.97.10061278. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of the isometric force | Assessment maximal isometric contractions (MVC) pre, at midway through the fatigue protocol, post fatigue protocol and after 10' of rest after the fatigue protocol. Maximum force reduction expressed in Newtons will be analyzed.
Subjects will be seated upright with back support. The hip and knee will be flexed to 90° and the force will be measured by a force transducer. |
baseline, 6 , 12 and 22 seconds | |
Primary | Change of maximal voluntary activation (VA) | Evaluation of the electrically stimulated resting force (Qtpot) and of the maximum voluntary activation (MVA). The electrical stimulation used will consist of single square wave pulses of 0.1 ms duration, delivered by a constant current stimulator (DS7AH, Digitimer). The intensity of the stimulus used will be defined as follows: the current will be progressively increased from 0 mA to the value beyond which there will be no further increase in force and the amplitude of the M wave. The stimulus used for the study will be set at 125% of the intensity required to produce a maximum M wave response.
Voluntary activation (VA) was then assessed using the interpolated twitch technique by comparing the force produced during a superimposed twitch on the MVC with the potentiated single twitch delivered 2-s afterwards. %VA = (1 - superimposed twitch force / Qtw,pot) · 100 |
baseline, 6 , 12 and 22 seconds | |
Primary | Change muscle electromyography | The M wave will be collected from the vastus lateralis after supramaximal electrical stimulation.The intensity of the stimulus used will be defined as follows: the current will be increased progressively from 0 mA to the value beyond which there will be no further increase in the amplitude of the M wave The stimulus used for the study will be set at 125% of the intensity required to produce a maximum M wave response. | baseline, 6 , 12 and 22 seconds | |
Primary | Change of Rate of Perceived Exertion RPE | Assess subjective perception of muscle exertion (peripheral fatigue) and breathing effort (dyspnea). It will be used on scales from 1 to 10. | baseline, 6 , 12 and 22 seconds | |
Secondary | Vascular function with sPLM | The evaluation of the vascular function will be performed with a Doppler ultrasound at the level of the common femoral artery, in basal conditions and during the application of the Single Passive Leg Movement (sPLM) technique. The sPLM test will be performed on the right common femoral artery, and measurements will be made using a Doppler ultrasound system (Logiq V4-GE, Milwaukee, WI, USA). The sPLM protocol will consist of 60 seconds of baseline data collection at rest, followed by a 1-second passive flexion-extension of the leg. The leg will then be kept fully extended for the remaining 60 s after the movement. For each subject the arterial diameter at rest, the blood flow at rest(LBF), the relative changes will be determined (Dpeak). The peak blood flow values, relative changes from rest after leg movement will be calculated second by second.
Leg blood flow will be calculeted LBF = Vmeanp(D/2)^2 x 60 |
baseline | |
Secondary | Monitoring muscle oxygenation | Evaluation of mitochondrial function in vivo by the Near InfraRed Spectroscopy (NIRS) method, applying a noninvasive probe on the Vastus Lateralis (VL). the relative concentration of deoxyhemoglobin and oxyhemoglobin in tissues during the fatigue protocol will be analyzed. Total hemoglobin (THb = HHb + HbO2) and Hb difference (Hbdiff = HbO2 - HHb) will be obtained as derived measurements. | up to 12 seconds | |
Secondary | Electromyographic evaluation during fatiguing protocol | Surface electromyography. Vastus lateralis (VL) electromyography (EMG) was continuously recorded. On the VL, two surface Ag/AgCl electrodes (PG10C; Fiab, Vicchio, Italy) were attached to the skin with a 20-mm inter-electrode distance. The electrodes were placed longitudinally, in line with the underlying muscle fibres arrangement, at two-thirds of the distance between the anterior iliac spine and the lateral part of the patella. For each muscle contraction, average root mean square of the EMG signal (EMGRMS) for the VL muscle will be calculat and normalized by the maximum | up to 12 seconds |
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