NCT04803617

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 23, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2017

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 13, 2021

Last Update Submit

March 16, 2021

Conditions

Keywords

pectoralis muscle strengthlung function testrespiratory muscle strengthhorizontal adduction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • FEV1

    5 minute

  • FVC

    5 minute

  • FEV1/FVC

    5 minute

  • Respiratory muscle strength test

    15 minute

  • Dyspnea assessment

    3 minute

Study Arms (2)

Patient's group

geriatric patients with interstitial lung disease

Other: Assessment of pulmonary function and pectoralis muscle strength

Control group

healthy volunteers selected from the geriatric population

Other: Assessment of pulmonary function and pectoralis muscle strength

Interventions

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 groupPatient's group

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
  • Aged 65-85

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giresun University

Giresun, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 21471066BACKGROUND
  • 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.

MeSH Terms

Conditions

Lung Diseases, InterstitialIdiopathic Pulmonary FibrosisSarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPulmonary FibrosisSarcoidosisLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Officials

  • Habibe DURDU, MSc

    Giresun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 17, 2021

Study Start

January 23, 2017

Primary Completion

June 23, 2017

Study Completion

June 23, 2017

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

The data sets collected and analyzed during this study could be provided from corresponding author upon reasonable request

Locations