NCT04765969

Brief Summary

The main purpose of chronic obstructive pulmonary disease (COPD) rehabilitation applications is to increase the functional capacity of the patients and improve the quality of life in daily living activities (ADL). Therefore, the investigators planned the study to determine the influence of ADL and related factors in severe COPD. GOLD C and D COPD patients admitted to Bezmialem Vakif University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Pulmonary Rehabilitation Application and Research Laboratory will be included in this study on a voluntary basis. Individuals who have experienced exacerbations of COPD in the last 6 weeks, have comorbidities affecting ambulation and have cognitive impairment will be excluded. Physical and sociodemographic characteristics of all participants will be recorded. Spirometric measurement will used to evaluate pulmonary functions, London Chest Activities Scale (LCADL) will used to evaluate daily living activities, six minute walking test (6MWT) will used to evaluate functional capacity, and mouth pressure will measured to evaluate respiratory muscle strength. (MIP: maximal inspiratory pressure, MEP: maximal expiratory pressure). Saint George Respiratory Questionnaire (SGRQ) for assessing quality of life, International Physical Activity Questionnaire (IPAQ) for assessing physical activity, COPD Assessment Test (CAT) for symptom assessment, and Hospital Anxiety and Depression Scale (HAD) for anxiety and depression assessment will be applied. SPSS 22.0 package program will be used in statistical analysis. For descriptive statistics, mean ± standard deviation values will be calculated and Pearson correlation test will be used in correlation analysis. p \<0.05 will be the level of significance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration 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 18, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

2.4 years

First QC Date

March 16, 2020

Last Update Submit

August 13, 2025

Conditions

Keywords

COPDActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • Activities of daily living

    The LCADL Scale is going to used to assess dyspnea resulting from ADL . It consists of a total of 15 items within four domains: personal care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). Each item is graded from 0 to 5 with higher scores indicating more difficulty performing ADL. The scale can be evaluated as total score, domain scores, and item scores. The maximum total score is 75. There is also a single question that assesses to what degree dyspnea perception affects daily life in general. This item is answered by selecting one of three responses: 'a lot', 'a little', or 'not at all'

    6 months

Secondary Outcomes (10)

  • Pulmonary Function Test

    6 months

  • FEV1 (liter)

    6 months

  • FEV1 (%-percentage)

    6 months

  • FVC (liter)

    6 months

  • FEV1/FVC (percentage)

    6 months

  • +5 more secondary outcomes

Other Outcomes (2)

  • Health related quality of life assessment

    6 months

  • Anxiety and depression

    6 months

Study Arms (1)

Severe COPD patients

GOLD C and D group patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD subjects who were referred to the Bezmialem Vakıf University

You may qualify if:

  • Pulmonary function tests (PFT) value of FEV₁ / FVC \<70%,
  • Being in GOLD III-IV groups,
  • Being over 18 years old,
  • Being able to read and to understand the spoken language.

You may not qualify if:

  • subjects have had COPD exacerbation in the last six weeks,
  • having comorbidities affecting ambulation and
  • cognitive disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34350, Turkey (Türkiye)

Location

Related Publications (2)

  • Ozsoy I, Ozcan Kahraman B, Acar S, Ozalevli S, Akkoclu A, Savci S. Factors Influencing Activities of Daily Living in Subjects With COPD. Respir Care. 2019 Feb;64(2):189-195. doi: 10.4187/respcare.05938. Epub 2018 Nov 6.

  • Kapella MC, Larson JL, Covey MK, Alex CG. Functional performance in chronic obstructive pulmonary disease declines with time. Med Sci Sports Exerc. 2011 Feb;43(2):218-24. doi: 10.1249/MSS.0b013e3181eb6024.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice-dean of Faculty of Health Sciences (PhD, PT)

Study Record Dates

First Submitted

March 16, 2020

First Posted

February 23, 2021

Study Start

January 18, 2019

Primary Completion

June 28, 2021

Study Completion

June 30, 2021

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Our clinical datas' are not available for sharig considering ethical problems.

Locations