Interstitial Lung DiseaseNCT05106556
Effect of Respiratory Muscle Training in Interstitial Lung Patients
A study testing Conventional Chest Physiotherapy and Inspiratory Muscle Training in people with Interstitial Lung Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Conventional Chest Physiotherapy and Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2019to 31 Jan 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.),
- Being clinically stable,
- Not receiving supplemental oxygen therapy,
- No pulmonary infection in the last 6 weeks,
- Being ambulation.
Who cannot join
- Presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis
- Presence of a history of effort-induced syncope
- Presence of severe orthopedic or neurological disease
- Presence of unstable serious cardiac disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih/Istanbul, 34093
About this study
Official title: The Effect of Respiratory Muscle Training on Respiratory Parameters, Functional Capacity, Balance and Quality of Life in Interstitial Lung Patients
The aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.
Read the detailed description
Interstitial lung disease (ILD) include a heterogeneous group of progressive, acute and chronic diseases that diffusely affect the lung and characterized by varying degrees of inflammation and fibrosis in the lung parenchyma. The disease group usually shows a restrictive pattern and progresses with gas exchange abnormalities.
Progressive lung fibrosis was first described in 1935. Over the years, more than 150 lung disease characterized by acute or chronic pulmonary fibrosis of varying degrees with known or unknown cause have been defined and these diseases were named interstitial lung disease (ILD) in 1970s. Common symptoms in chronic interstitial lung diseases in general; dyspnea, dry cough, exercise intolerance and fatigue. All these features of interstitial lung diseases cause an increase in respiratory work and ventilatory deterioration in exercise. Apart from these general features, muscle weakness and related exercise intolerance may occur in some specific conditions.
The most important factor limiting exercise capacity in these patients is circulatory disorder, which cause exercise induced deterioration in gas exchange. Hypoxemia induced exercise intolerance causes a decrease in health-related quality of life, limitation of functional capacity and inactivity in daily life.
According to the American Thoracic Society (ATS) / European Respiratory Society (ERS) respiratory rehabilitation guideline, although the data are not conclusive, inspiratory muscle training is recommended as an adjunct to pulmonary rehabilitation, especially in patients with suspected or confirmed respiratory muscle weakness. The effect of well-structured and supervised inspiratory muscle training (IMT) on respiratory functions, diaphragm weakness, functional capacity, balance and quality of life in patients with interstitial lung disease is unknown.
It is important that this research will be carried out in this area and because it has a current subject.
- Conditions
- Interstitial Lung Disease
- Being tested
- Conventional Chest Physiotherapy, Inspiratory Muscle Training
- Keywords
- Interstitial lung disease, Interstitial pulmonary fibrosis, Sarcoidosis, Respiratory muscle training, Pulmonary Function, Functional Capacity, Physiotherapy, Balance, Quality of Life, 6 Minute Walk Test
- Medical subject headings
- Lung Diseases, Interstitial, Pulmonary Fibrosis, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Chest PhysiotherapyOther
Programme will include diaphragmatic breathing exercise, pursed lip breathing exercise, thoracic expansion exercises, upper and lower extremity exercises, stretching the pectoral muscles, posture exercises, walking training and teaching respiratory control.
Inspiratory Muscle TrainingOther
Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure with the threshold loading method.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 weeks. After the training given by the physiotherapist one exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Maximal inspiratory mouth pressure measurements will be measured once a week to eliminate the effect of learning, however the training intensity will remain at the lowest intensity of the device for 8 weeks and will not be increased. Receives: Other: Conventional Chest Physiotherapy |
| Inspiratory Muscle Training (IMT) Group | Experimental | In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home.
Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value. Receives: Other: Conventional Chest Physiotherapy; Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Function Test / Forced Vital Capacity (FVC)
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Eight weeks
Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function test at 8 weeks. FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Eight weeks
Respiratory Function Test / Peak Expiratory Flow (PEF)
Change from baseline Peak Expiratory Flow (PEF) in respiratory function test at 8 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Eight weeks
Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)
Change from baseline Tiffeneau-Pinelli index (Forced Expiratory Volume 1 second (FEV1) / Forced Vital Capacity (FVC)) in respiratory function test at 8 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Eight weeks
Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Eight weeks
Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: Eight weeks
Functional Capacity
Change from baseline distance covered in six-minute walk test at 8 weeks
Measured: Eight weeks
Balance / Postural Stability
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Measured: Eight weeks
Balance / Limits of Stability
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Balance / Sensory Integration and Balance Test Score
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
Measured: Eight weeks
Secondary outcomes (4)
Peripheral Muscle Strength
Change from baseline M. Quadriceps strength at 8 weeks. It will be performed using an electronic hand dynamometer (Commander Muscle Tester; JTECH Medical, USA). M. Quadriceps muscle strength will be measured; it will evaluate the isometric muscle strength of that muscle by applying maximum resistance to the M. Quadriceps muscle with the electronic hand dynamometer.
Measured: Eight weeks
Pain Level
Change from baseline Visual Analogue Scale (VAS) at 8 weeks.This scale consists of a horizontal, straight line. The line has a value of 0 at the beginning and a value of 10 at the end. A value of 0 means no pain, a value of 10 means unbearable pain. high values represent severe pain.
Measured: Eight weeks
Dyspnea
Change from baseline Modified Medical Research Council Dyspnea Scale (mMRC) at 8 weeks. The Modified Medical Research Council Dyspnea Scale (mMRC) is a five-item scale based on various activities that cause breathlessness. The scale is rated from "0" to "4". High values indicate severe shortness of breath.
Measured: Eight weeks
Health-Related Quality of Life
Change from baseline St. George's Respiratory Questionnaire (SGRQ) at 8 weeks. St. George's Respiratory Questionnaire consists of 76 questions that can be filled in about 15 minutes. It consists of 3 subgroups that evaluate respiratory symptoms (dyspnea, cough, sputum, wheezing, severity and frequency), activity status (physical functions that cause shortness of breath, housework, hobbies) and the impact of the disease (social activities and psychological state). The three parts of the test are scored separately and the total score is calculated. Scores range from 0-100. A score of zero indicates normal and a score of 100 indicates maximum disability.
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 posted3 Nov 2021
- Study start9 Dec 2019
- Primary completion3 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Model description
- Group 1: Inspiratory Muscle Training (IMT) Group Group 2: Control Group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Aydın, Bezmialem Vakif University
- Investigators
- Onur AYDIN, PhD (c), Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106556
- Sponsor's protocol ID
- BezmialemVU-AYDIN-001
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 3 Nov 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Respiratory Muscle Training on Respiratory Parameters, Functional Capacity, Balance and Quality of Life in Interstitial Lung Patients
- ClinicalTrials.gov ID
- NCT05106556
- Acronym / sponsor ID
- BezmialemVU-AYDIN-001
- Conditions
- Interstitial Lung Disease
- Keywords
- Interstitial lung disease, Interstitial pulmonary fibrosis, Sarcoidosis, Respiratory muscle training, Pulmonary Function, Functional Capacity, Physiotherapy, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 3 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 3 Nov 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 aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.
Detailed description
Interstitial lung disease (ILD) include a heterogeneous group of progressive, acute and chronic diseases that diffusely affect the lung and characterized by varying degrees of inflammation and fibrosis in the lung parenchyma. The disease group usually shows a restrictive pattern and progresses with gas exchange abnormalities.
Progressive lung fibrosis was first described in 1935. Over the years, more than 150 lung disease characterized by acute or chronic pulmonary fibrosis of varying degrees with known or unknown cause have been defined and these diseases were named interstitial lung disease (ILD) in 1970s. Common symptoms in chronic interstitial lung diseases in general; dyspnea, dry cough, exercise intolerance and fatigue. All these features of interstitial lung diseases cause an increase in respiratory work and ventilatory deterioration in exercise. Apart from these general features, muscle weakness and related exercise intolerance may occur in some specific conditions.
The most important factor limiting exercise capacity in these patients is circulatory disorder, which cause exercise induced deterioration in gas exchange. Hypoxemia induced exercise intolerance causes a decrease in health-related quality of life, limitation of functional capacity and inactivity in daily life.
According to the American Thoracic Society (ATS) / European Respiratory Society (ERS) respiratory rehabilitation guideline, although the data are not conclusive, inspiratory muscle training is recommended as an adjunct to pulmonary rehabilitation, especially in patients with suspected or confirmed respiratory muscle weakness. The effect of well-structured and supervised inspiratory muscle training (IMT) on respiratory functions, diaphragm weakness, functional capacity, balance and quality of life in patients with interstitial lung disease is unknown.
It is important that this research will be carried out in this area and because it has a current subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Inspiratory Muscle Training (IMT) Group Group 2: Control Group
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Conventional Chest PhysiotherapyPatients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 weeks. After the training given by the physiotherapist one exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week to eliminate the effect of learning, however the training intensity will remain at the lowest intensity of the device for 8 weeks and will not be increased. |
| Inspiratory Muscle Training (IMT) Group | Experimental | Other: Conventional Chest Physiotherapy, Other: Inspiratory Muscle TrainingIn addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.),
- Being clinically stable,
- Not receiving supplemental oxygen therapy,
- No pulmonary infection in the last 6 weeks,
- Being ambulation.
Key exclusion criteria (4 listed)
- Presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis
- Presence of a history of effort-induced syncope
- Presence of severe orthopedic or neurological disease
- Presence of unstable serious cardiac disease
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 |
|---|---|---|
| Conventional Chest PhysiotherapyProgramme will include diaphragmatic breathing exercise, pursed lip breathing exercise, thoracic expansion exercises, upper and lower extremity exercises, stretching the pectoral muscles, posture exercises, walking training and teaching respiratory control. | Other | Control Group, Inspiratory Muscle Training (IMT) Group |
| Inspiratory Muscle TrainingThreshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure with the threshold loading method. | Other | Inspiratory Muscle Training (IMT) Group |
Primary outcome
Respiratory Function Test / Forced Vital Capacity (FVC)
Time frame: Eight weeks
Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)
Time frame: Eight weeks
Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function test at 8 weeks. FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Peak Expiratory Flow (PEF)
Time frame: Eight weeks
Change from baseline Peak Expiratory Flow (PEF) in respiratory function test at 8 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)
Time frame: Eight weeks
Change from baseline Tiffeneau-Pinelli index (Forced Expiratory Volume 1 second (FEV1) / Forced Vital Capacity (FVC)) in respiratory function test at 8 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)
Time frame: Eight weeks
Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)
Time frame: Eight weeks
Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Functional Capacity
Time frame: Eight weeks
Change from baseline distance covered in six-minute walk test at 8 weeks
Balance / Postural Stability
Time frame: Eight weeks
Change from baseline postural stability test score in Biodex Balance System at 8 weeks
Balance / Limits of Stability
Time frame: Eight weeks
Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks
Balance / Sensory Integration and Balance Test Score
Time frame: Eight weeks
Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks
4 secondary outcomes
Peripheral Muscle Strength
Time frame: Eight weeks
Pain Level
Time frame: Eight weeks
Dyspnea
Time frame: Eight weeks
Health-Related Quality of Life
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
Onur AYDIN, PhD (c) principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Chest Physiotherapy and Inspiratory Muscle Training in people with Interstitial Lung Disease, run by Bezmialem Vakif 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 5 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 3 Nov 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Function Test / Forced Vital Capacity (FVC) (time frame: Eight weeks). The study lists 10 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 3 Nov 2021.