NCT04811859

The Effect of Inspiratory Muscle Training in Post COVID-19 Patients

Status unknown NA Last updated 23 March 2021

What this trial tests

NA trial testing Inspiratory Muscle Training in Covid19 in 40 participants. Status unknown.

Timeline

10 January 2021

Primary endpoint
10 January 2022

10 March 2022

Quick facts

Lead sponsor	Istinye University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	10 January 2021
Primary completion	10 January 2022
Estimated completion	10 March 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Inspiratory Muscle Training

Conditions studied

• Covid19 — all drugs for Covid19 →
• Infective Pneumonia — all drugs for Infective Pneumonia →

Sponsor

Istinye University

Who can join

Adults 18 to 70, any sex, with Covid19 or Infective Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The COVID-19 infection, which is considered as a pandemic by the World Health Organization, affects the whole world. COVID-19 is an infectious respiratory disease caused by SARS-CoV-2. It is stated in early studies that after COVID-19 infection, there are adverse effects on both the peripheral and respiratory muscles along with the pulmonary system involvement. The purpose of our study; To examine the effect of Inspiratory Muscle Training (IMT) on respiratory muscle strength, respiratory functions and functional capacity in PostCOVID-19 patients. Patients who have been hospitalized and discharged with the diagnosis of COVID-19 in Istinye University hospitals, at least 6 weeks have passed since the infection, the PCR test has turned negative will be taken. The evaluation and treatment of the patients will be carried out in the Education and Research Units of Istinye University Physiotherapy and Rehabilitation Department. Patients included in the study will be randomly divided into two groups, study and control groups. Demographic evaluation form, Post Covid Functional Status Scale, Charlson Comorbidity Index, Modified Medical Research Council (MMRC) Dyspnea scale, Corbin posture analysis, Respiratory function test, Respiratory muscle strength measurement, Respiratory Muscle Endurance measurement, 6-minute walking test (6 MWT) ), Peripheral Muscle Strength, Grip Strength, Hospital Anxiety and Depression Scale (HADS), Breathlessness Perception Questionnaire (BBQ) and Nottingham Health Profile Questionnaire will be used. In the study group, IMT will be applied at 40% of the maximum inspiratory pressure (MIP) for eight weeks, every day of the week, twice a day for 15 minutes. The patients will come for a control once a week, the MIP values will be measured again and the new training intensity will be determined at 40% of the new MIP value. The control group will be given a constant training of 15 minutes at 10% of the MIP, twice a day, every day of the week for eight weeks. Evaluations of the study and control groups will be made at the beginning and after eight weeks.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. At a crossroads: coronavirus disease 2019 recovery and the risk of pulmonary vascular disease.
   Cascino TM, Desai AA, Kanthi Y. · · 2021 · cited 10× · PMID 34127622 · DOI 10.1097/mcp.0000000000000792