NCT05746702

Brief Summary

The former aim of this study is to determine whether the arm swings change in patients with Chronic Obstructive Pulmonary Disease (COPD) according to healthy subjects. The latter purposes to investigate the correlation between balance parameters and arm swing, how to change arm swing according to severity of the disease, and to determine the relationship between balance and the severity of disease, the relationship of posture both arm swing and severity of disease in patients with COPD. In accordance with this purposes, 20 patients with COPD who have Global Initiative for Chronic Obstruction Lung Disease (GOLD) stage 1-2-3 and 20 healthy controls will be included between the ages of 40 and 65, respectively. Tests and questionnaires will be used in order to determine the severity of COPD and to evaluate posture. Berg Balance Scale, Time Up and Go Test, 6 Minute Pegboard and Ring Test, 6 Minute Walk Test and gait analysis will be performed. It is expected that by determining the parameters that can be affected by severity of COPD. It is estimate to have information about severity of the disease by means of observational analysis. It will guide professional working in the field.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2024

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

January 30, 2023

Last Update Submit

July 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Arm Swings Characteristics

    Change of the arm swings during 6 minute gait in patients with Chronic Obstructive Pulmonary Disease according to healthy subjects.

    1 day

Secondary Outcomes (6)

  • Spatiotemporal Characteristic

    1 day

  • Upper Extremity Functional Capacity

    1 day

  • Balance

    1 day

  • Severity of Disease

    1 day

  • Posture

    1 day

  • +1 more secondary outcomes

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients referred by the department of chest diseases of Hacettepe university will be taken.

You may qualify if:

  • Who has been clinically stable for the last 4 weeks,
  • who will be able to walk independently for 6 minutes,
  • According to the Classification of Airflow Limitation in COPD (GOLD) system, the Stage is 1-2-3,
  • who declares that he has not taken part in any other research

You may not qualify if:

  • walking assistive devices,
  • receiving chronic oxygen therapy,
  • with central and peripheral vestibular disease,
  • with orthopedic, neuromuscular, neurological and cardiac diseases that may affect gait and balance,
  • with a history of lung cancer, sarcoidosis, tuberculosis and/or lung surgery,
  • who has communication problems,
  • with mental and cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aynur Demirel

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveGait Disorders, NeurologicDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsRespiration DisordersSigns and Symptoms, Respiratory

Study Officials

  • Aynur Demirel, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD, Assoc. Prof.

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 28, 2023

Study Start

March 1, 2023

Primary Completion

June 19, 2024

Study Completion

October 19, 2024

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations