Determination of Factors Effecting Falls in Patients With COPD

NCT06483776 | Not Yet Recruiting

• 1 other identifier: SBA 24/519
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine the factors affecting falls in patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive; Fall; Balance; Distorted

Outcome Measures

Primary Outcomes (3)

• Balance and Fall risk

  Time up and go test will be used to assess balance and fall risk. The cut off point will be determined as 12 second for patients with COPD.

  1 day

• Balance and Fall risk-The Mini-Balance Evaluation Systems Test (Mini-BESTest)

  It will be used to evaluate individuals' static and dynamic balance. It consists of four sub-parameters: preparatory movements, reactive postural control, sensory orientation, and dynamic gait, with a total of four items. The test, which takes an average of 10-15 minutes to complete, is evaluated out of a total of 28 points. A higher score indicates higher function. This test is valid and reliable in patients with COPD.

  1 day

• Balance and Fall risk- The Activities-specific Balance Confidence scale (ABC scale)

  It will be used to evaluate fall risk. A validity and reliability study has been conducted in Turkish. This scale assesses balance confidence based on functional status with 16 task-specific questions. Each question is scored between 0% (no confidence) and 100% (full confidence), and a higher total score indicates higher confidence. Scores below 67% indicate fall risk in elderly individuals. It is valid and reliable for determining fall risk in individuals with COPD.

  1 day

Secondary Outcomes (13)

• Functional exercise capacity

  1 day

• Respiratory Muscle Strength

  1 day

• Posture

  1 day

• Dyspnea

  1 day

• Symptoms

  1 day

Study Arms (1)

COPD

Patients with Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with COPD s will be included in this study.

You may qualify if:

• Being between the ages of 45 and 80,
• Being literate,
• Willing to participate in the study,
• Having COPD classified as stage 1-2-3-4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) system,
• Being clinically stable for the past 4 weeks.

You may not qualify if:

• Having a history of lung cancer, sarcoidosis, tuberculosis, and/or lung surgery,
• Having any neurological, neuromuscular, vestibular, or cardiac disease that could affect the measurements,
• Receiving long-term oxygen therapy.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aynur Demirel, PT, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aynur Demirel, PT, PhD

CONTACT

+905545295057; aynur.demirel@hacettepe.edu.tr

Hidaye Yamikan, PT,MSc

CONTACT

+905349898724; hidaye.yamikan@hacettepe.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator; PT, PhD, Assoc. Prof.

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Locations

TU (1)