Effects of IMT on Functional Capacity in Patients With Chronic COVID After Hospital Discharge

NCT05279430 | Completed

• 1 other identifier: 2021/226
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise intolerance and fatigue are the most common symptoms in patients with chronic COVID after hospital discharge. Muscle deconditioning, dysautonomia, and exercise hyperventilation have been proposed as potential mechanisms contributing to exercise functional capacity limitation in Long-COVID. Along this line, combined exercise training or inspiratory muscle training (IMT) alone have already been demonstrated to be feasible therapeutic options for Long-COVID patients. However, we do not have evidence about the effects of a home-based IMT program for 12-week on peak oxygen consumption (peakVO2). in patients chronic COVID (\>3 months) after hospital discharge. 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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Peak oxygen consumption

  Maximal functional capacity will be evaluated with incremental and symptom-limited cardiopulmonary exercise testing. Peak oxygen consumption (peakVO2) will be considered the highest value of VO2 during the last 20 seconds of exercise.

  12-week

Study Arms (2)

Control arm

NO INTERVENTION

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

Inspiratory muscle training

ACTIVE COMPARATOR

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.

Behavioral: Inspiratory muscle training

Interventions

Inspiratory muscle training BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic adult patients \>18 years old with the previous admission due to SARS-CoV-2 pneumonia
• \> 3-month after discharge
• The patient provides informed consent

You may not qualify if:

• Inability to perform a maximal baseline exercise test
• Structural heart disease, valve heart disease, or diastolic dysfunction estimated by 2-dimensional echocardiography
• Patients with previous ischemic heart disease, heart failure, myocardiopathy, or myocarditis
• Effort angina or signs of ischemia during CPET
• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

INCLIVA

Valencia, 46010, Spain

Location

Related Publications (4)

• 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.

  PMID: 27481035 RESULT

• 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.

  PMID: 23864363 RESULT

• 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.

  PMID: 36549786 DERIVED

• 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.

  PMID: 35790316 DERIVED

Study Officials

• Patricia Palau, MD, PhD

  INCLIVA-Hospital Clínico Universitario

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and clinical professor

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: March 15, 2022
• Study Start: January 30, 2022
• Primary Completion: July 31, 2022
• Study Completion: August 1, 2022
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 3 months after publication
• Access Criteria: Data is available upon the reasonable request

Locations

ES (1)