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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04803617
Other study ID # Pectoralismajor
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 23, 2017
Est. completion date June 23, 2017

Study information

Verified date March 2021
Source Giresun University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The aim of this study were to evaluated the change of pectoralis muscle strength and relationship of pulmonary function with pectoralis muscle strength.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 23, 2017
Est. primary completion date June 23, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Assessment of pulmonary function and pectoralis muscle strength
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.

Locations

Country Name City State
Turkey Giresun University Giresun

Sponsors (1)

Lead Sponsor Collaborator
Habibedurdu

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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 inters — View Citation

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.2 — View Citation

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. Review. — View Citation

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, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 minute
Secondary 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. 5 minute
Secondary 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. 5 minute
Secondary FEV1/FVC The ratio of FEV1/FVC was calculated by measuring device according to measured FEV1 and FVC values 5 minute
Secondary 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 15 minute
Secondary Dyspnea assessment Modified Medical Council Research Dyspnea scale were used to assess sensation of dyspnea 3 minute
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