- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803617
Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease
March 16, 2021 updated by: Habibedurdu
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
68
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Giresun, Turkey
- Giresun University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 85 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
- Aged 65-85
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient's group
geriatric patients with interstitial lung disease
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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.
|
|
Control group
healthy volunteers selected from the geriatric population
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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15 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1
Time Frame: 5 minute
|
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.
|
5 minute
|
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FVC
Time Frame: 5 minute
|
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.
|
5 minute
|
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FEV1/FVC
Time Frame: 5 minute
|
The ratio of FEV1/FVC was calculated by measuring device according to measured FEV1 and FVC values
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5 minute
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Respiratory muscle strength test
Time Frame: 15 minute
|
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
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15 minute
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Dyspnea assessment
Time Frame: 3 minute
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Modified Medical Council Research Dyspnea scale were used to assess sensation of dyspnea
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3 minute
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Habibe DURDU, MSc, Giresun University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Hirano 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.
- Panagiotou 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.
- Hanada 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.
- Durdu 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 23, 2017
Primary Completion (Actual)
June 23, 2017
Study Completion (Actual)
June 23, 2017
Study Registration Dates
First Submitted
March 13, 2021
First Submitted That Met QC Criteria
March 16, 2021
First Posted (Actual)
March 17, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pectoralismajor
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data sets collected and analyzed during this study could be provided from corresponding author upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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