Covid19NCT04811859
The Effect of Inspiratory Muscle Training in Post COVID-19 Patients
A study testing Inspiratory Muscle Training in people with Covid19 and Infective Pneumonia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19, Infective Pneumonia
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2021to 10 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of mental and cognitive impairments
- Having an orthopedic, neurological disease that prevents exercise
- Uncontrolled hypertension, having a cardiovascular disease
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye University
Istanbul, 34010
Ali Osman Çırak, MSc, PT, +905541960150, aliosman_cirak@hotmail.com
About this study
Official title: The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Functions and Functional Capacity in Post COVID-19 Patients
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.
- Conditions
- Covid19, Infective Pneumonia
- Being tested
- Inspiratory Muscle Training
- Keywords
- Inspiratory Muscle Training, Post-COVID 19, Respiratory Muscle Strength, Respiratory Function, Functional Capacity
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start10 Jan 2021
- Primary completion10 Jan 2022 (estimated)
- Study completion10 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811859
- Sponsor's protocol ID
- ISUCPR
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Respiratory Functions and Functional Capacity in Post COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04811859
- Acronym / sponsor ID
- ISUCPR
- Conditions
- Covid19, Infective Pneumonia
- Keywords
- Inspiratory Muscle Training, Post-COVID 19, Respiratory Muscle Strength, Respiratory Function, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 10 Jan 2022 (estimated)
- Study completion
- 10 Mar 2022 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Other: Inspiratory Muscle TrainingIn 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. |
| Control group | Sham comparator | Other: Inspiratory Muscle TrainingIn 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Presence of mental and cognitive impairments
- Having an orthopedic, neurological disease that prevents exercise
- Uncontrolled hypertension, having a cardiovascular disease
- Pregnancy and breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingInspiratory 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. | Other | Control group, Study Group |
Primary outcome
PostCovid Functional Status Scale
Time frame: eight weeks
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
Time frame: eight weeks
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
Time frame: eight weeks
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
Time frame: eight weeks
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
Time frame: eight weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Covid19 and Infective Pneumonia, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PostCovid Functional Status Scale (time frame: eight weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.