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Clinical Trials/NCT05632120
NCT05632120
Enrolling By Invitation
Not Applicable

Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions According to the ICF Framework in Chronic Obstructive Pulmonary Diseases

Istanbul University - Cerrahpasa1 site in 1 country50 target enrollmentDecember 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Istanbul University - Cerrahpasa
Enrollment
50
Locations
1
Primary Endpoint
Activities-Specific Balance Confidence scale
Status
Enrolling By Invitation
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 5, 2022
End Date
March 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa
Responsible Party
Principal Investigator
Principal Investigator

Tansu Birinci

Principal Investigator

Istanbul University - Cerrahpasa

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Activities-Specific Balance Confidence scale

Time Frame: Baseline

Activities-Specific Balance Confidence (ABC) scale will be used for evaluating the confidence in maintaining the balance in activities daily living. It provides information on the level of concern about falls during16 community-based and home-based activities. Scale scores between 0 (unsafe) to 100 (completely safe) and the total score (0-1600) is divided by 16 to obtain an individual's ABC score, with higher scores indicating greater balance confidence. In patients with COPD, the ABC scale has demonstrated construct validity as well as criterion validity for falls. In addition, the participants will be also questioned concerning the occurrence of falls and the risk of falling during the activity in each item of the ABC scale.

Secondary Outcomes

  • London Chest Activity of Daily Living scale(Baseline)
  • The COPD Assessment Test(Baseline)
  • The strength of quadriceps femoris(Baseline)
  • The Modified Medical Research Council Dyspnea scale(Baseline)
  • Six-Minute Walking Test (6MWT)(Baseline)

Study Sites (1)

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