Clinical trial NCT04765969: Determination of Factors Related With Daily Living Activities in Severe COPD
Official title: Determination of Factors Related With Daily Living Activities in Severe COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: COPD
Activities of Daily Living
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD subjects who were referred to the Bezmialem Vakıf 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Activities of daily living
timeFrame: 6 months
Secondary outcomes:
measure: Pulmonary Function Test
timeFrame: 6 months
measure: FEV1 (liter)
timeFrame: 6 months
measure: FEV1 (%-percentage)
timeFrame: 6 months
measure: FVC (liter)
timeFrame: 6 months
measure: FEV1/FVC (percentage)
timeFrame: 6 months
measure: Inspiratory muscle test
timeFrame: 6 months
measure: Functional capacity
timeFrame: 6 months
measure: Symptoms
timeFrame: 6 months
measure: Physical activity
timeFrame: 6 months
measure: Expiratory muscle test
timeFrame: 6 months
Other outcomes:
measure: Health related quality of life assessment
timeFrame: 6 months
measure: Anxiety and depression
timeFrame: 6 months
Locations:
city: İstanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
References:
citation: 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.
citation: 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.