Effects of IMT on Functional Capacity in Patients With Chronic COVID After Hospital Discharge
NCT ID: NCT05279430
Last Updated: 2022-12-13
Study Results
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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COMPLETED
NA
26 participants
INTERVENTIONAL
2022-01-30
2022-08-01
Brief Summary
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This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a program of IMT that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12-week. Patients with chronic COVID (\>3 months) after hospital discharge will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +3 mL/kg/min (SD±2.5)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Detailed Description
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This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a program of IMT that will be carried out in a single center. Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12-week. Patients with chronic COVID (\>3 months) after hospital discharge will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +3 mL/kg/min (SD±2.5)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control arm
Patients allocated to the control arm will not receive inspiratory muscle training. They will be checked each week by a physiotherapist responsible for training intervention who will measure their maximal inspiratory pressure
No interventions assigned to this group
Inspiratory muscle training
Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured.
Inspiratory muscle training
Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured.
Interventions
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Inspiratory muscle training
Patients allocated to the IMT arm will be instructed to train at home twice daily, for 20 minutes each session, using a Threshold inspiratory muscle trainer (Respironics Inc., Parsippany, NJ). They will be instructed by a physiotherapist responsible for training intervention and educated to maintain diaphragmatic breathing during the training period. The subjects will start breathing at a resistance equal to 25% to 30% of their maximal inspiratory mouth pressure (MIP) for 1 week. The respiratory therapist will examine the patients at weekly intervals by checking the diary card and measuring the MIP each time. The resistance will be modified each session according to the 25% to 30% of their MIP measured.
Eligibility Criteria
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Inclusion Criteria
2. \> 3-month after discharge
3. The patient provides informed consent
Exclusion Criteria
2. Structural heart disease, valve heart disease, or diastolic dysfunction estimated by 2-dimensional echocardiography
3. Patients with previous ischemic heart disease, heart failure, myocardiopathy, or myocarditis
4. Effort angina or signs of ischemia during CPET
5. Significant primary pulmonary disease, including a history of pulmonary arterial hypertension, chronic thromboembolic pulmonary disease, or chronic obstructive pulmonary disease
(g) Treatment with digitalis, calcium channel blockers, β-blocker or ivabradine (h) Patients with chronic kidney disease (glomerular filtration rate \<60mL/min/1.73m2) (i) Patients with pacemakers or previous history of atrial fibrillation; (j) patients with autoimmune, inflammatory or active neoplastic disease k) Anemia (l) Pregnancy.
18 Years
90 Years
ALL
No
Sponsors
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Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Patricia Palau
Principal Investigator and clinical professor
Principal Investigators
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Patricia Palau, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
INCLIVA-Hospital Clínico Universitario
Locations
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INCLIVA
Valencia, , Spain
Countries
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References
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Palau P, Dominguez E, Lopez L, Heredia R, Gonzalez J, Ramon JM, Serra P, Santas E, Bodi V, Sanchis J, Chorro FJ, Nunez J. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial. Clin Cardiol. 2016 Aug;39(8):433-9. doi: 10.1002/clc.22555. Epub 2016 Aug 2.
Palau P, Dominguez E, Nunez E, Schmid JP, Vergara P, Ramon JM, Mascarell B, Sanchis J, Chorro FJ, Nunez J. Effects of inspiratory muscle training in patients with heart failure with preserved ejection fraction. Eur J Prev Cardiol. 2014 Dec;21(12):1465-73. doi: 10.1177/2047487313498832. Epub 2013 Jul 17.
Palau P, Dominguez E, Gonzalez C, Bondia E, Albiach C, Sastre C, Martinez ML, Nunez J, Lopez L. Effect of a home-based inspiratory muscle training programme on functional capacity in postdischarged patients with long COVID: the InsCOVID trial. BMJ Open Respir Res. 2022 Dec;9(1):e001439. doi: 10.1136/bmjresp-2022-001439.
Palau P, Dominguez E, Sastre C, Martinez ML, Gonzalez C, Bondia E, Albiach C, Nunez J, Lopez L. Effect of a home-based inspiratory muscular training programme on functional capacity in patients with chronic COVID-19 after a hospital discharge: protocol for a randomised control trial (InsCOVID trial). BMJ Open Respir Res. 2022 Jul;9(1):e001255. doi: 10.1136/bmjresp-2022-001255.
Other Identifiers
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2021/226
Identifier Type: -
Identifier Source: org_study_id