The Risk of Falling in Patients with Chronic Obstructive Pulmonary Disease

NCT ID: NCT04074499

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-08-31

Study Completion Date

2019-12-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This cross-sectional study aims to investigate what daily activities increase the risk of falling in Chronic Obstructive Pulmonary Disease patients (COPD).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To investigate the what daily activities increase the risk of falling in patients with COPD, twenty-eight voluntary patients with COPD, aged between 35-80 years will be divided into two groups: Group-1 have at least one fall (fallers) and Group-2 have no history of falls (non-fallers). Fall frequency will be investigated by asking patients to report any fall event in the last one month and the last 12-months. Assessments will be performed at baseline. Fear of falling will be assessed with Activities-Specific Balance Confidence (ABC) scale. Balance will be evaluated by Berg Balance Scale (BBS). 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). 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. 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. Among the groups, demographic and clinical variables will be compared with independent sample t-test for continuous variables and a chi-square test for categorical variables. The significance level will be set as p\<0.05.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease Fall Balance; Distorted Activity, Motor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group-1

The patients were classified based on the frequency of falls in the last 12 months.

Group-1 consists of COPD patients whose have at least one fall (fallers)

No intervention

Intervention Type OTHER

There is no intervention.

Group-2

The patients were classified based on the frequency of falls in the last 12 months.

Group-2 consists of COPD patients whose have no history of falls (non-fallers).

No intervention

Intervention Type OTHER

There is no intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

There is no intervention.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Tansu Birinci

PT, MSc Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tansu Birinci, MSc

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, Bakırkoy, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

459535

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.