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

NCT05632120 | Enrolling By Invitation

• 1 other identifier: 212121
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Balance; Activity, Motor; Participation, Patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead
• Istanbul Medeniyet University: collaborator
• Biruni University: collaborator
• Istanbul University: collaborator

Study Sites (1)

Istanbul University

Istanbul, Fatih/İstanbul, 34452, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity; Patient Participation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Tansu Birinci, PT, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: December 5, 2022
• Primary Completion: February 25, 2023
• Study Completion: March 30, 2025
• Last Updated: January 30, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)