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

Primary Purpose

Covid19, Infective Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
Istinye University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Inspiratory Muscle Training, Post-COVID 19, Respiratory Muscle Strength, Respiratory Function, Functional Capacity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Istinye UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study Group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 25, 2021
Last Updated
March 22, 2021
Sponsor
Istinye University
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1. Study Identification

Unique Protocol Identification Number
NCT04811859
Brief Title
The Effect of Inspiratory Muscle Training in Post COVID-19 Patients
Official Title
The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Functions and Functional Capacity in Post COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2021 (Actual)
Primary Completion Date
January 10, 2022 (Anticipated)
Study Completion Date
March 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istinye University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Infective Pneumonia
Keywords
Inspiratory Muscle Training, Post-COVID 19, Respiratory Muscle Strength, Respiratory Function, Functional Capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
PostCovid Functional Status Scale
Description
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.
Time Frame
eight weeks
Title
Pulmonary Function Test
Description
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.
Time Frame
eight weeks
Title
Inspiratory muscle strength
Description
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.
Time Frame
eight weeks
Title
Functional capacity
Description
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.
Time Frame
eight weeks
Title
Expiratory muscle strength
Description
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.
Time Frame
eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Presence of mental and cognitive impairments Having an orthopedic, neurological disease that prevents exercise Uncontrolled hypertension, having a cardiovascular disease Pregnancy and breastfeeding
Facility Information:
Facility Name
Istinye University
City
İstanbul
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Osman Çırak, MSc, PT
Phone
+905541960150
Email
aliosman_cirak@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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