Determination of Factors Related With Daily Living Activities in Severe COPD

Completed

• Conditions: COPD

• Registration Number: NCT04765969
• Lead Sponsor: Halic University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-18
• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-23
• Primary Completion: 2021-06-28
• Study Completion: 2021-06-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-02
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Activities of daily living	6 months	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'

Secondary Outcome Measures

Name	Time	Method
FEV1 (liter)	6 months	This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.
Pulmonary Function Test	6 months	Spirometer is performed according to the American Thoracic Society (ATS) guidelines in Bezmialem University PFT Laboratory with Zan-100 spire (nSpire Health GmbH, Oberthulba, Germany). FVC (l), FEV₁(l), FEV1(%), FEV₁/FVC (%) were recorded.
Symptoms	6 months	For the symptom burden of COPD, COPD Assessment Test (CAT) is going to used. It consists of eight items, each presented as a semantic 6-point differential scale, providing a score out of 40 indicating the impact of the disease
FVC (liter)	6 months	This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.
FEV1 (%-percentage)	6 months	This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.
FEV1/FVC (percentage)	6 months	The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.
Expiratory muscle test	6 months	Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Inspiratory muscle test	6 months	Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).
Functional capacity	6 months	Functional capacity is going to assessed with the 6 minute walk test (6MWT) according to the guideline of ATS .
Physical activity	6 months	It provides information about time spent on walking, moderate to severe activities. Time spent in sitting is considered as a separate question. The calculation of the total score of the short form includes the sum of walking, moderate intensity activity, and duration (minutes) and frequency (days) of intensive activity.

Trial Locations

Locations (1)

Bezmialem Vakıf University; 🇹🇷 İstanbul, Turkey