NCT06171425

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 25, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2024

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

7 days

First QC Date

October 30, 2023

Last Update Submit

December 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • comorbidity assesment

    1 time which will be in one day

  • exercise capacity

    1 time which will be in one day

  • balance measurement

    day 1

  • posture analysis

    day 1

  • posture related conditions measurement

    day 1

  • +6 more secondary outcomes

Study Arms (2)

DPAH group

patients with diffuse parenchymal lung diseases

control group

aged matched healthy patients

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Health Sciences Faculty

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases, InterstitialFrailtySedentary Behavior

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD, Assoc. Prof.

Study Record Dates

First Submitted

October 30, 2023

First Posted

December 14, 2023

Study Start

December 25, 2023

Primary Completion

January 1, 2024

Study Completion

February 22, 2024

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations