Interstitial Lung DiseaseNCT04803617
Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Habibedurdu at 1 site in Turkey (Türkiye).
Trial summary
Interstitial lung disease (ILD) is a restrictive lung disease characterized by impaired lung function, exercise limitation and skeletal muscle dysfunction. There is limited data on skeletal muscle function in ILD, most of which are focused on the lower limb muscles. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Pulmonary
- What is being tested?
- Assessment of pulmonary function and pectoralis muscle strength
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2017to 23 Jun 2017
- Phase
- Observational
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The patient's group was selected from among the patients who applied to Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital. The control group was selected among volunteers invited from the local community.
Who may be able to join
- Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
- Aged 65-85
Who cannot join
- Uncontrolled/active cardiovascular, metabolic, systemic or cancerous disease
- Significant orthopedic, neurologic or musculoskeletal comorbidity that limited functional independence
- No being able to cooperate
- Refuse to participate in the current study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pectoralis Muscle Strength on Pulmonary Function in Elderly With Interstitial Lung Disease
Interstitial lung disease (ILD) is a restrictive lung disease characterized by impaired lung function, exercise limitation and skeletal muscle dysfunction. There is limited data on skeletal muscle function in ILD, most of which are focused on the lower limb muscles. The aim of this study were to evaluated the change of pectoralis muscle strength and relationship of pulmonary function with pectoralis muscle strength.
Read the detailed description
This study consisted of intervention and control groups. Thirty one patients with ILD were included in the patient's group and 37 healthy volunteers in the control group. All participants were selected from the geriatric population. Demographic and cardiopulmonary physiotherapy assessment of all participants were performed. Lung function test, maximal inspiratory and expiratory pressure and pectoralis muscle strength were measured in participants of both groups. All measurements were performed once.
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Pulmonary, Geriatric
- Being tested
- Assessment of pulmonary function and pectoralis muscle strength
- Keywords
- pectoralis muscle strength, lung function test, respiratory muscle strength, horizontal adduction
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of pulmonary function and pectoralis muscle strengthOther
In both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines. Sensation of dyspnea was assessed with Modified medical council research scale. Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| Patient's group | geriatric patients with interstitial lung disease Receives: Other: Assessment of pulmonary function and pectoralis muscle strength | |
| Control group | healthy volunteers selected from the geriatric population Receives: Other: Assessment of pulmonary function and pectoralis muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pectoralis muscle strength test
The pectoralis muscle strength were measured with handheld dynamometer in supine position. The shoulder joint of participant was positioned at 90º abducted and at 0º internal/external rotation and the elbow joint was flexed at 90º. The other shoulder joint was fixed by the physiotherapist. While the participant performed isometrically horizontal adduction movement, the measurement was performed on the distal part of the upper arm and the contraction was sustained for at least 5 seconds by the participant. The test was performed three times and with 60 seconds rest between tests. The mean of the best value on both sides was recorded.
Measured: 15 minute
Secondary outcomes (5)
FEV1
FEV1 value was measured with portable spirometer according to ATS/ ERS guidelines for pulmonary function test. Results of the measurements were recorded as percentanges of predicted values.
Measured: 5 minute
FVC
FVC value was measured with portable spirometer according to ATS/ ERS guidelines for pulmonary function test. Results of the measurements were recorded as percentanges of predicted values.
Measured: 5 minute
FEV1/FVC
The ratio of FEV1/FVC was calculated by measuring device according to measured FEV1 and FVC values
Measured: 5 minute
Respiratory muscle strength test
Maximal mouth pressures were measured to evaluate respiratory muscle strength. The test was performed with mouth pressure device in sitting position. Participants breathed through a flanged mouthpiece inside the lips at near residual volume for the MIP value and near total lung capacity for MEP value . The maximum effort was sustained for at least one second. The test was repeated at least 3 times until no more than 10% difference was present between highest and previous measurements . The higest value and percentage value of predicted highest value were recorded
Measured: 15 minute
Dyspnea assessment
Modified Medical Council Research Dyspnea scale were used to assess sensation of dyspnea
Measured: 3 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start23 Jan 2017
- Primary completion23 Jun 2017
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Habibedurdu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Habibedurdu, Giresun University
- Investigators
- Habibe DURDU, MSc, Principal investigator, Giresun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803617
- Sponsor's protocol ID
- Pectoralismajor
- Status last verified
- Mar 2021
- First submitted
- 13 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets collected and analyzed during this study could be provided from corresponding author upon reasonable request
Publications
Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
PubMed 21471066Hirano M, Katoh M, Kawaguchi S, Uemura T. Intrarater reliabilities of shoulder joint horizontal adductor muscle strength measurements using a handheld dynamometer for geriatric and stroke patients. J Phys Ther Sci. 2016 Jan;28(1):51-5. doi: 10.1589/jpts.28.51. Epub 2016 Jan 30.
PubMed 26957727Panagiotou M, Polychronopoulos V, Strange C. Respiratory and lower limb muscle function in interstitial lung disease. Chron Respir Dis. 2016 May;13(2):162-72. doi: 10.1177/1479972315626014. Epub 2016 Jan 14.
PubMed 26768011Hanada M, Sakamoto N, Ishimatsu Y, Kakugawa T, Obase Y, Kozu R, Senjyu H, Izumikawa K, Mukae H, Kohno S. Effect of long-term treatment with corticosteroids on skeletal muscle strength, functional exercise capacity and health status in patients with interstitial lung disease. Respirology. 2016 Aug;21(6):1088-93. doi: 10.1111/resp.12807. Epub 2016 May 13.
PubMed 27173103Durdu H, Yurdalan SU, Ozmen I. Clinical significance of pectoralis muscle strength in elderly patients with idiopathic pulmonary fibrosis. Sarcoidosis Vasc Diffuse Lung Dis. 2022;39(1):e2022009. doi: 10.36141/svdld.v39i1.12094. Epub 2022 Mar 31.
PubMed 35494168
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pectoralis Muscle Strength on Pulmonary Function in Elderly With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04803617
- Acronym / sponsor ID
- Pectoralismajor
- Conditions
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Sarcoidosis, Pulmonary, Geriatric
- Keywords
- pectoralis muscle strength, lung function test, respiratory muscle strength, horizontal adduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- HabibedurduUniversity, hospital or other
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 23 Jun 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 17 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.
Interstitial lung disease (ILD) is a restrictive lung disease characterized by impaired lung function, exercise limitation and skeletal muscle dysfunction. There is limited data on skeletal muscle function in ILD, most of which are focused on the lower limb muscles. The aim of this study were to evaluated the change of pectoralis muscle strength and relationship of pulmonary function with pectoralis muscle strength.
Detailed description
This study consisted of intervention and control groups. Thirty one patients with ILD were included in the patient's group and 37 healthy volunteers in the control group. All participants were selected from the geriatric population. Demographic and cardiopulmonary physiotherapy assessment of all participants were performed. Lung function test, maximal inspiratory and expiratory pressure and pectoralis muscle strength were measured in participants of both groups. All measurements were performed once.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient's group | – | Other: Assessment of pulmonary function and pectoralis muscle strengthgeriatric patients with interstitial lung disease |
| Control group | – | Other: Assessment of pulmonary function and pectoralis muscle strengthhealthy volunteers selected from the geriatric population |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The patient's group was selected from among the patients who applied to Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital. The control group was selected among volunteers invited from the local community.
Key inclusion criteria (2 listed)
- Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
- Aged 65-85
Key exclusion criteria (4 listed)
- Uncontrolled/active cardiovascular, metabolic, systemic or cancerous disease
- Significant orthopedic, neurologic or musculoskeletal comorbidity that limited functional independence
- No being able to cooperate
- Refuse to participate in the current study
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 |
|---|---|---|
| Assessment of pulmonary function and pectoralis muscle strengthIn both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines. Sensation of dyspnea was assessed with Modified medical council research scale. Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer. | Other | Control group, Patient's group |
Primary outcome
Pectoralis muscle strength test
Time frame: 15 minute
The pectoralis muscle strength were measured with handheld dynamometer in supine position. The shoulder joint of participant was positioned at 90º abducted and at 0º internal/external rotation and the elbow joint was flexed at 90º. The other shoulder joint was fixed by the physiotherapist. While the participant performed isometrically horizontal adduction movement, the measurement was performed on the distal part of the upper arm and the contraction was sustained for at least 5 seconds by the participant. The test was performed three times and with 60 seconds rest between tests. The mean of the best value on both sides was recorded.
5 secondary outcomes
FEV1
Time frame: 5 minute
FVC
Time frame: 5 minute
FEV1/FVC
Time frame: 5 minute
Respiratory muscle strength test
Time frame: 15 minute
Dyspnea assessment
Time frame: 3 minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 21471066Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Results publication: PubMed 26957727Hirano M, Katoh M, Kawaguchi S, Uemura T. Intrarater reliabilities of shoulder joint horizontal adductor muscle strength measurements using a handheld dynamometer for geriatric and stroke patients. J Phys Ther Sci. 2016 Jan;28(1):51-5. doi: 10.1589/jpts.28.51. Epub 2016 Jan 30.
- Results publication: PubMed 26768011Panagiotou M, Polychronopoulos V, Strange C. Respiratory and lower limb muscle function in interstitial lung disease. Chron Respir Dis. 2016 May;13(2):162-72. doi: 10.1177/1479972315626014. Epub 2016 Jan 14.
- Results publication: PubMed 27173103Hanada M, Sakamoto N, Ishimatsu Y, Kakugawa T, Obase Y, Kozu R, Senjyu H, Izumikawa K, Mukae H, Kohno S. Effect of long-term treatment with corticosteroids on skeletal muscle strength, functional exercise capacity and health status in patients with interstitial lung disease. Respirology. 2016 Aug;21(6):1088-93. doi: 10.1111/resp.12807. Epub 2016 May 13.
- Derived from this study: PubMed 35494168Durdu H, Yurdalan SU, Ozmen I. Clinical significance of pectoralis muscle strength in elderly patients with idiopathic pulmonary fibrosis. Sarcoidosis Vasc Diffuse Lung Dis. 2022;39(1):e2022009. doi: 10.36141/svdld.v39i1.12094. Epub 2022 Mar 31.
- Individual participant dataSharing planned: No. The data sets collected and analyzed during this study could be provided from corresponding author upon reasonable request
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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.
Habibe DURDU, MSc principal investigator
Giresun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by Habibedurdu 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 2 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: finished, as of the sponsor's last update on 17 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pectoralis muscle strength test (time frame: 15 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803617, which also lists 5 linked publications.
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 17 Mar 2021.