Evaluation of Patients With Diffuse Parenchymal Lung Diseases Regarding Frailty

Diffüz Parankimal Akciğer Hastalarında Kırılganlık Düzeyi, Egzersiz Kapasitesi ve Denge Değerlendirilmesi

There are very few studies in the literature examining the frailty levels of diffuse parenchymal lung disease (DPLD) patients and its effect on their functional status despite the high prevalance of frailty in patients with DPLD This observational study aims to learn about the relationship between frailty and functional capacity and balance in DPLD patients compared to healthy subjects.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Physical Inactivity; Diffuse Parenchymal Lung Disease

Detailed Description

The aim of the study is to evaluate the relationship between the level of frailty and exercise capacity, respiratory functions, diffusion capacity, balance level, postural changes, activities of daily living, peripheral muscle strength and quality of life parameters in DPLD patients. The second aim is to compare diffuse parenchymal lung patients and the healthy control group in terms of these parameters.

• Study Type: Observational
• Enrollment (Estimated): 28

Contacts and Locations

• Study Contact: Name: Aynur Demirel; Phone Number: 05545295057; Email: aynurdemirel629@hotmail.com
• Study Contact Backup: Name: AYNUR DEMIREL, Assoc. Prof.; Phone Number: 178 +9053123051576; Email: aynur.demirel@hacettepe.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University, Health Sciences Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients referred by the department of chest diseases of Hacettepe university will be taken

Description

Inclusion Criteria:

• Being diagnosed with Diffuse parenchymal lung according to the American Thoracic Society/European Respiratory Society (ATS/ERS) criteria,
• Being between the ages of 30-65,
• Being literate,
• Being willing to participate in the research,
• Being clinically stable and having any accompanying comorbid conditions (such as hypertension, diabetes) under control,
• Not having any orthopedic, metabolic or neurological problems that may prevent evaluation of peripheral muscle strength, balance and exercise capacity.

Exclusion Criteria:

• Having recently experienced syncope,
• Having a history of unstable cardiovascular disease,
• Having been hospitalized due to exacerbation in the last 3 months,
• Having received pulmonary rehabilitation in the last 12 months,
• Having a neurological disease,
• Being dependent and using a walking aid while performing the person's daily life activities,
• Having a pacemaker,
• Having a diagnosis of lung cancer

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
DPAH group; patients with diffuse parenchymal lung diseases
control group; aged matched healthy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frailty level	evaluation of frailty level with Fried Frailty Criteria which are weight loss existence, muscle strength, physical activity (will be measured with International Physical Activity Questionnaire), mobility (will be measured by 4-meter walking test), and depression level. Fried frailty phenotype consists of five criteria: loss, exhaustion, physical inactivity, low hand grip strength, and slow walking speed. Patients who have three or more of these criteria are defined as frail, those who have one or two criteria, are defined as prefrail, and none of the criteria are defined as robust.	1 time which will be in one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comorbidity assesment	via Charlson comorbidity index (values between 0-33)	1 time which will be in one day
exercise capacity	by 1 minute sit to stand test	1 time which will be in one day
balance measurement	by timed up and go test	day 1
posture analysis	corbin postural assesment scale from lateral and posterior view will be applied. The Corbin Posture Scale is a postural assessment scale that evaluates the inclination of the head in different directions, the shape of the dorsal region, the presence of scapulaand shoulder protraction, the signs of scoliosis, kyphosis, lordosis, whether there is a difference in the height of the two shoulders and hips, the sagging status in the abdominal region, the presence of gibbosity, genu recurvatum, and the level of anterior balance by assigning a score between 0-3.	day 1
posture related conditions measurement	observational analysis by scapular dyskinesia test	day 1
posture related (scapular motion)conditions existence measurement	by lateral scapular slide test which evaluates distance between medial border of spine scapulae and T3 spinous process- T7 spinous process and inferior angle of scapulae	day 1
quality of life evaluation	Quality of life will be assessed by Saint George respiratory questionnaire. A total score is calculated from 0 (no health impairment) to 100 (maximum health impairment).	day 1
evaluation of participation to daily life activities	Participation to daily life activities will be evaluated by London Chest Activities of Daily Living Questionnare. Contains 15 items grouped into four domains: self-care, household activities (domestic), physical, and leisure activities. Responses for each item range from 0-5, with 0 indicating "wouldn't do anyway", 1-4 representing degree of breathlessness and 5 representing the greatest difficulty with performing ADL (someone else completes). Responses to items 1-15 are added; the total score can range from 0 to 75 points, with higher scores indicating greater functional limitation	day 1
pulmonary function measurement	evaluation of pulmonary function with lung function test which will be detected via FVC, FEV1, FEV1/FVC, PEF, FEF25-75% At least three technically acceptable measurements were obtained between the two best-measured FEV1 values, with no more than a 5% difference, and the best FEV1 value was selected for analysis.	day 1
investigation of diffusion capacity of the lung	by diffusion capacity of carbon monoxide of lung with single breath method	day 1
peripheral muscle strength	by hand held dynamometry device	day 1

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Estimated): December 25, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): February 22, 2024

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Frailty; Lung Diseases, Interstitial
• Other Study ID Numbers: GO 23/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No