Evaluation of Patients With Diffuse Parenchymal Lung Diseases Regarding Frailty

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06171425
• Other study ID #: GO 23/18
• Status: Not yet recruiting
• Start date: December 25, 2023
• Est. completion date: February 22, 2024

Study information

• Verified date: December 2023
• Source: Hacettepe University
• Contact: AYNUR DEMIREL, Assoc. Prof.
• Phone: +9053123051576
• Email: aynur.demirel[@]hacettepe.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: February 22, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diffuse Parenchymal Lung Disease
• Frailty
• Lung Diseases
• Lung Diseases, Interstitial
• Physical Inactivity

Locations

Country	Name	City	State
Turkey	Hacettepe University, Health Sciences Faculty	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	comorbidity assesment	via Charlson comorbidity index (values between 0-33)	1 time which will be in one day
Secondary	exercise capacity	by 1 minute sit to stand test	1 time which will be in one day
Secondary	balance measurement	by timed up and go test	day 1
Secondary	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
Secondary	posture related conditions measurement	observational analysis by scapular dyskinesia test	day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	investigation of diffusion capacity of the lung	by diffusion capacity of carbon monoxide of lung with single breath method	day 1
Secondary	peripheral muscle strength	by hand held dynamometry device	day 1