Clinical trial NCT05632120: Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions in COPD
Official title: Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions According to the ICF Framework in Chronic Obstructive Pulmonary Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Obstructive Pulmonary Disease
Balance
Activity, Motor
Participation, Patient
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Istanbul Medeniyet University
name: Biruni University
name: Istanbul University
First posted: 2022-11-30
Enrollment: 50
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants will be patients with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines were recruited from Istanbul University, Department of Chest Diseases.

Brief summary: This cross-sectional study aims to investigate to the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in Chronic Obstructive Pulmonary Diseases (COPD) patients.

Detailed description: To investigate the impairments in body functions and structures, activities and participation restrictions according to the International Classification of Functioning, Disability and Health (ICF) framework in patients with COPD, fifty patients with COPD will be included.

The Modified Medical Research Council Dyspnea (MMRC) scale and Six-Minute Walking Test (6MWT) will be used for evaluating the how dyspnea limits the patients' daily activities and functional capacity, respectively. Isometric muscle strength will be measured with a handheld dynamometer of quadriceps femoris. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. The level of dyspnea during daily activities will be assessed with London Chest Activity of Daily Living (LCADL) scale. The global impacts of COPD symptoms on overall health status will be evaluated by The COPD Assessment Test (CAT). Pulmonary function data will be retrieved from the last 1-month clinical records of the COPD patients. Statistical analysis will be performed using the Statistical Package for Social Sciences (SPSS) version 21.0. Descriptive statistics of continuous variables will be presented with mean, standard deviation (SD), confidence interval (CI) values, and descriptive statistics of categorical variables will be presented with frequency and percentage values. The conformity of the data to the normal distribution will be evaluated with the "Shapiro Wilk Test". According to the results of the analysis, "Pearson correlation test" or "Spearman correlation test" will be used to determine the relationship between dependent variables. The significance level will be set as p\<0.05.

Eligibility criteria: Inclusion Criteria:

1. stable disease (no severe exacerbations in the prior 3 months)
2. ability to walk independently
3. ability to read and write in Turkish
4. able to follow simple instructions
5. no pathology in visual ability and hearing

Exclusion Criteria:

1. a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder)
2. severe musculoskeletal, neurological or cardiovascular disorders that limit mobility
3. use of medication(s) that may increase the risk of falls
4. participate in pulmonary rehabilitation in the lasts six months

Primary outcomes:
measure: Activities-Specific Balance Confidence scale
timeFrame: Baseline
Secondary outcomes:
measure: London Chest Activity of Daily Living scale
timeFrame: Baseline
measure: The COPD Assessment Test
timeFrame: Baseline
measure: The strength of quadriceps femoris
timeFrame: Baseline
measure: The Modified Medical Research Council Dyspnea scale
timeFrame: Baseline
measure: Six-Minute Walking Test (6MWT)
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
state: Fatih/İstanbul
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Tansu Birinci, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: