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NCT05279430: InsCOVID

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

Completed NA Last updated 13 December 2022
What this trial tests

NA trial testing Inspiratory muscle training in COVID-19 Pneumonia in 26 participants. Completed in 1 August 2022.

Timeline
30 January 2022
Primary endpoint
31 July 2022
1 August 2022

Quick facts

Lead sponsorFundación para la Investigación del Hospital Clínico de Valencia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment26
Start date30 January 2022
Primary completion31 July 2022
Estimated completion1 August 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Who can join

Adults 18 to 90, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of a home-based inspiratory muscle training programme on functional capacity in postdischarged patients with long COVID: the InsCOVID trial.
    Palau P, Domínguez E, Gonzalez C, Bondía E, et al · · 2022 · cited 24× · PMID 36549786 · DOI 10.1136/bmjresp-2022-001439
  2. 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).
    Palau P, Domínguez E, Sastre C, Martínez ML, et al · · 2022 · cited 7× · PMID 35790316 · DOI 10.1136/bmjresp-2022-001255
  3. Unraveling the Mechanisms Behind Exercise Intolerance and Recovery in Long COVID.
    Palau P, Calvo B, Sastre C, Domínguez E, et al · · 2025 · cited 2× · PMID 38648998 · DOI 10.1016/j.amjmed.2024.04.023

Verify or expand the search:

Other trials of Inspiratory muscle training

Trials testing the same drug.

Other recruiting trials for COVID-19 Pneumonia

Currently open trials in the same condition.

Other Fundación para la Investigación del Hospital Clínico de Valencia trials

Trials by the same sponsor.

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Data sources for this page

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