NCT04062292

Brief Summary

In the literature, most of the studies examining the gait characteristics and balance separately or examining the relationship between them are on patients with COPD. No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma was found.A convincing link between gait disturbances and falls in COPD patients is still unknown and further research is needed. Therefore, the purpose of our study; gait parameters and balance in individuals with obstructive pulmonary disease. We will also examine the relationship between gait parameters and extrapulmonary clinical indicators of these individuals.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 17, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

5.4 years

First QC Date

August 15, 2019

Last Update Submit

August 29, 2024

Conditions

Keywords

balancechronic obstructive diseases

Outcome Measures

Primary Outcomes (1)

  • Gait parameters

    Gait parameters will be assessed with Biodex Gait Trainer (Biodex Medical Systems, Shirley, New York) for six minutes.

    01.09.2020-08.07.2021

Secondary Outcomes (5)

  • Functional Balance and Fall Risk

    01.09.2020-08.07.2021

  • Functional Exercise Capacity

    01.09.2020-08.07.2021

  • Respiratory Muscle Strength

    01.09.2020-08.07.2021

  • Peripheral Muscle Strength

    01.09.2020-08.07.2021

  • Cognitive Status

    01.09.2020-08.07.2021

Study Arms (2)

Obstructive lung diseases group

1. Having been diagnosed with obstructive pulmonary disease, 2. No acute exacerbation or infection in the past 1 week, Being between the ages of 18 and 65,

Healthy group

Age and sex matched healthy subjects without orthopedic and chronic diseases

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The obstructive lung diseases from every subgroups: COPD, asthma and bronchiectasis patients

You may qualify if:

  • Being diagnosed with obstructive lung disease,
  • Have not experienced acute exacerbation or infection in the last 1 week,
  • To be between 18-65 years,
  • Volunteering for research,
  • To be able to walk and cooperate.

You may not qualify if:

  • Use walking aid or be chronic oxygen support
  • To have orthopedic or neuromuscular comorbidities that may affect walking patterns.
  • Having had lung cancer, sarcoidosis, tuberculosis disease or lung surgery.
  • Having any cardiopulmonary disease,
  • To have an advanced orthopedic disease that may affect functional capacity measurement and gait patterns.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naciye Vardar-Yagli

Ankara, 06100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naciye Vardar-Yagli, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 20, 2019

Study Start

July 17, 2019

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

August 30, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations