Clinical trial NCT04595097: Inspiratory Muscle Training in COVID-19 Patients
Official title: Adjunctive Inspiratory Muscle Training for Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Exercise
Keywords: respiratory function tests
inspiratory muscle training
Lead sponsor: Escola Superior de Ciencias da Saude
Sponsor class: OTHER
Collaborators: name: University of Brasilia
name: JBS/CNPq
First posted: 2020-10-20
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.


Eligibility criteria: Inclusion Criteria:

To be eligible, participants must be:

* over 18 years of age
* confirmed COVID-19 diagnosis
* Individuals that required hospitalization and either i) non-invasive respiratory support (CPAP, high-flow oxygen catheter, non-breathing oxygen mask, or ii) invasive mechanical ventilation within three months of study recruitment.

Exclusion Criteria:

* Pregnancy
* Dependence on others to perform activities of daily living during the month prior to the current ICU admission (gait aids are acceptable)
* documented cognitive impairment
* Proven or suspected spinal cord injury, or other neuromuscular diseases that will result in a permanent or prolonged weakness (not including ICU acquired weakness)
* Severe neurological disease
* Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision-maker are not committed to full active treatment.

Primary outcomes:
measure: Cardiopulmonary Exercise Testing Measurements
timeFrame: change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months
Secondary outcomes:
measure: severity of fatigue
timeFrame: change from baseline in FSS score at 8 weeks and 6 months
measure: Anxiety and Depression
timeFrame: Change from baseline in HADS score at 8 weeks and 6 months
measure: incremental cost-utility ratio
timeFrame: 6 months
measure: Health- related quality of life
timeFrame: change from baseline in EQ-5D score at 8 weeks and 6 months
measure: Pulmonary function testing
timeFrame: change from baseline in FEV1 and FVC in Liters at 8 weeks and 6 months.
measure: Dyspnea
timeFrame: change from baseline in mMRC score at 8 weeks and 6 months
measure: Respiratory muscle strength
timeFrame: change from baseline in MIP and MEP at 8 weeks and 6 months
measure: Postural Control
timeFrame: change from baseline in Postural stability test and fall risk test at 8 weeks
measure: isometric knee extension strength
timeFrame: change from baseline in Nm at 8 weeks
measure: displacement
timeFrame: change from baseline in CM2 at 8 weeks
measure: trajectory
timeFrame: change from baseline in CM2 at 8 weeks
measure: isometric knee flexion strength
timeFrame: change from baseline in Nm at 8 weeks
measure: dynamic balance
timeFrame: change from baseline in Total score at 8 weeks
measure: Sit to Stand Test
timeFrame: change from baseline in repetitions at 8 weeks
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Secretaria de Saúde do Distrito Federal
state: DF
Study officials:
References:
citation: Maldaner V, Coutinho J, Santana ANDC, Cipriano GFB, Oliveira MC, Carrijo MM, Lino MEM, Cahalin LP, Lima AG, Borges R, Santos DB, Silva IO, Oliveira LVF, Cipriano G Jr. Adjunctive inspiratory muscle training for patients with COVID-19 (COVIDIMT): protocol for randomised controlled double-blind trial. BMJ Open. 2021 Sep 22;11(9):e049545. doi: 10.1136/bmjopen-2021-049545.