Investigation of Impairments in Body Functions and Structures, Activities and Participation Restrictions in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05632120
• Other study ID #: 212121
• Status: Enrolling by invitation
• Start date: December 5, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Activity, Motor
• Balance
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Participation, Patient
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul	Fatih/Istanbul

Sponsors (4)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)	Biruni University, Istanbul Medeniyet University, Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activities-Specific Balance Confidence scale	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.	Baseline
Secondary	London Chest Activity of Daily Living scale	London Chest Activity of Daily Living (LCADL) scale is used for assessing the level of dyspnea during daily activities.; It is a 15-item scale comprised 4 domains: self-care (4 items), domestic (6 items), physical (2 items), and leisure (3 items). Each item scored between 0 (I wouldn't do it anyway) to 5 (I need help in doing this or someone to do it for me) and the total score ranges from 0 to 75, with higher scores indicating a more significant limitation in daily activities.; The LCADL scale is a reliable, valid, and responsive instrument to assess limitations in performing daily activities in COPD patients. asked to rate each item in terms of risk of falling using a five-point scale, where 1=very low, 2=low, 3=moderate, 4=high, and 5=very high.	Baseline
Secondary	The COPD Assessment Test	The COPD Assessment Test (CAT) will be used for evaluating the global impacts of COPD symptoms on overall health status. Each item scores between 0 to 5 and the total score ranges from 0 to 40, with higher scores indicating the more severe impact of COPD on health status.	Baseline
Secondary	The strength of quadriceps femoris	The strength of quadriceps femoris of both sides will be measured with a hand-held dynamometer (kg.N-1) ''Nicholas Manual Muscle Tester" (model 01160, The Lafayette Instrument Company, Lafayette, Indiana). Each limb will assessed 3 times, with a recovery period of 30 seconds and the mean value will be calculated.	Baseline
Secondary	The Modified Medical Research Council Dyspnea scale	The Modified Medical Research Council Dyspnea (mMRC) scale will be used to determine how dyspnea limits the patients' daily activities performance. Itis a five-level rating scale consisting of just five items containing statements about the impact of dyspnea on the patients' daily activities performance and leading to a grade from 1 to 5. Higher scores indicate a greater impact of dyspnea on the patients' daily activities performance.	Baseline
Secondary	Six-Minute Walking Test (6MWT)	Six-Minute Walking Test (6MWT) is a reliable and valid test for evaluating functional capacity. Two 6MWTs will be performed according to the guidelines of the American Thoracic Society. The distance in meters covered over the 6 minutes of the test (6MWD) will be recorded.	Baseline