NCT04811859

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

February 25, 2021

Last Update Submit

March 22, 2021

Conditions

Covid19Infective Pneumonia

Keywords

Inspiratory Muscle TrainingPost-COVID 19Respiratory Muscle StrengthRespiratory FunctionFunctional Capacity

Outcome Measures

Primary Outcomes (5)

  • PostCovid Functional Status Scale

    PostCovid Functional Status Scale: It will be used to assess the functional status of patients after COVID-19 infection. It divides the functional status of the patients into stages between 0 and 4.

    eight weeks

  • Pulmonary Function Test

    Pulmonary Function Test will be performed using a portable spirometry according to the guidelines of the American Thoracic Society. Forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow (PEF) will be expressed as the percentages of the predicted values.

    eight weeks

  • Inspiratory muscle strength

    Inspiratory muscle strength are the static inspiratory pressure measured at the mouth. It is called maximal inspiratory pressure (MIP) and it will be assessed using an electronic pressure transducer. The MIP will be measured at residual volume.

    eight weeks

  • Functional capacity

    Six-minute walk test (6MWT) will be applied in a 30-m unobstructed corridor. Patients and controls will be instructed to walk their own pace but to cover as much meter as possible within 6 min.The distance will be recorded.

    eight weeks

  • Expiratory muscle strength

    Expiratory muscle strength are the static expiratory pressure measured at the mouth. It is called maximal expiratory pressure (MEP) and it will be assessed using an electronic pressure transducer. The MEP will be measured from total lung capacity.

    eight weeks

Study Arms (2)

Study Group

EXPERIMENTAL

In the study group, Inspiratory Muscle Training will be applied with Threshold IMT device (Respironics, USA) at 40% of the maximum inspiratory pressure value 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 maximum inspiratory pressure will be measured again and the new training intensity will be determined at 40% of the new maximum inspiratory pressure.

Other: Inspiratory Muscle Training

Control group

SHAM COMPARATOR

In the control group, Inspiratory Muscle Training will be applied with Threshold IMT device (Respironics, USA) at 10% of the maximum inspiratory pressure value for eight weeks, every day of the week, twice a day for 15 minutes. The exercise workload will not be increased and will remain the same. It will run at 10% of maximum inspiratory pressure for eight weeks.

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle TrainingOTHER

Inspiratory Muscle Training is a form of resistance (weight) training which strengthens the muscles that you use to breathe. When these muscles are strengthened regularly for a period of a few weeks they adapt, becoming stronger and being able to work for longer.

Control groupStudy Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults ages 18-70
  • Being clinically stable,
  • Having COVID-19 infection and at least 6 weeks after infection
  • Being between Grade 2-4 according to Post-COVID Functional Status Scale
  • Regular participation in treatment
  • To read, write and understand Turkish
  • Volunteering to participate in research

You may not qualify if:

  • Presence of mental and cognitive impairments
  • Having an orthopedic, neurological disease that prevents exercise
  • Uncontrolled hypertension, having a cardiovascular disease
  • Pregnancy and breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 23, 2021

Study Start

January 10, 2021

Primary Completion

January 10, 2022

Study Completion

March 10, 2022

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)