NCT07178197

Brief Summary

Sarcopenia negatively affects the prognosis of chronic diseases. However, the importance of sarcopenia in patients with idiopathic pulmonary fibrosis (IPF) has been less emphasized. The aim of the study is to determine the prevalence of sarcopenia in patients with IPF and to evaluate the impact of sarcopenia on quality of life and disease progression. This study was designed as a descriptive cross-sectional. The study included patients diagnosed with IPF. Hand dynamometry and bioelectrical impedance analysis (BIA) were used to for diagnose of sarcopenia. Pulmonary function tests, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) measurements were examined. The 6-minute walk distance (6MWD) and 4-meter walking speed were recorded. The St. George Respiratory Questionnaire (SGRQ) was used to assess quality of life. All patients were evaluated for progressive disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 17, 2025

Completed
Last Updated

September 17, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 25, 2025

Last Update Submit

September 15, 2025

Conditions

Keywords

idiopathic pulmonary fibrosissarcopeniaskeletal muscle mass indexbioelectrical impedance analysis

Outcome Measures

Primary Outcomes (11)

  • Hand Grip Strength

    Hand Grip Strength (kg)- Grip strength measurement using a hand dynamometer

    through study completion, an average of 1 year

  • SMI (skeletal muscle mass index)

    SMI (skeletal muscle mass index) (kg/m2) - SMI measurement using the Bioelectrical Impedance Analysis (BIA) device

    through study completion, an average of 1 year

  • Forced Expiratory Volume in 1 second (FEV1)

    Measurement of FEV1 for the assessment of pulmonary function

    through study completion, an average of 1 year

  • Forced Vital Capacity (FVC)

    Measurement of FVC for the assessment of pulmonary function

    through study completion, an average of 1 year

  • Diffusing Capacity of The Lungs for Carbon Monoxide (DLCO)

    Measurement of DLCO for the assessment of pulmonary function.

    through study completion, an average of 1 year

  • Total Lung Capacity (TLC)

    Measurement of TLC for the assessment of pulmonary function.

    through study completion, an average of 1 year

  • Respiratory Muscle Strength

    Measurement of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) for assessment of respiratory muscle strength

    through study completion, an average of 1 year

  • Six Minute Walk Test (6MWT)

    Distance walked in six minutes (m)

    through study completion, an average of 1 year

  • Gait speed

    4-meter walking speed (m/s)

    through study completion, an average of 1 year

  • St. George's Respiratory Questionnaire (SGRQ)

    The questionnaire is designed to measure quality of life. It consists of symptom, activity, impact, and total scores. Each score ranges from 0 to 100. High scores indicate lower quality of life.

    through study completion, an average of 1 year

  • Progressive Disease

    Examination of all participants from clinical, physiological, and radiological perspectives

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Body Mass Index ( BMI)

    through study completion, an average of 1 year

Study Arms (1)

idiopathic pulmonary fibrosis (IPF)

The prevalence of sarcopenia was investigated in patients with IPF who met the inclusion and exclusion criteria. The relationship between sarcopenia and quality of life and disease progression in patients with IPF was evaluated.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients included in the study were those diagnosed with IPF according to the ATS/ERS/JRS/ALAT 2022 guidelines and who applied to the Department of Pulmonary Diseases at Mersin University Faculty of Medicine.

You may qualify if:

  • Being over 18 years of age
  • Signing the informed consent form
  • Having a diagnosis of IPF for at least one month

You may not qualify if:

  • Pregnancy
  • History of cancer within the last 5 years
  • History of lung surgery
  • History of neuromuscular disease
  • Active pulmonary tuberculosis
  • Active respiratory tract infection
  • Inability to perform pulmonary function tests
  • Presence of a pacemaker
  • History of systemic steroid use within the past 3 months
  • Inability to use a hand dynamometer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Medicine

Mersin, Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Idiopathic Pulmonary FibrosisSarcopenia

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 17, 2025

Study Start

December 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

September 17, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations