- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062292
Gait Parameters and Balance in Patients With Obstructive Lung Diseases
Investigation of Gait Parameters and Balance in Patients With Obstructive Lung Diseases
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.
Study Overview
Status
Conditions
Detailed Description
Patients with COPD call walking as one of the most problematic activities in daily life. Patients with COPD walk less in daily life than their healthy peers. Gait characteristics of extrapulmonary comorbidities that probably affect the musculoskeletal and cardiovascular system vary. The gait assessment gives an idea about the biomechanical factors associated with a reduction in walking distance in COPD patients. In patients with COPD, after the onset of shortness of breath or leg fatigue, a decrease in cadence during walking, shortened stride length, an increase in the time spent in the double support period, an increase in the peak ankle dorsi flexion moment is observed. During gait, there is an increase in balance disorders in the mediolateral direction. In addition, patients with COPD walk on a constant speed treadmill with more stride time and less step width variability. Studies have shown that patients with COPD have increased temporal walking characteristics, decreased step and stride length, and increased walking variability.
In the literature, most of the studies that examine gait characteristics and balance separately or examine the relationship between them are on patients with COPD. No study examining gait parameters in other obstructive pulmonary patients such as bronchiectasis and asthma has been found. A persuasive link between walking disorders and falls in COPD patients is still unknown and further research is needed. This study will contribute to clarifying the mechanisms of why the balance studied in patients with COPD is adversely affected.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Naciye Vardar-Yagli, PhD
- Phone Number: 123 +903123051576
- Email: naciyevardar@yahoo.com
Study Locations
-
-
-
Ankara, Turkey, 06100
- Recruiting
- Naciye Vardar-Yagli
-
Sub-Investigator:
- Melda Saglam, PhD
-
Contact:
- Naciye Vardar-Yagli, PhD
- Phone Number: 123 +903123051576
- Email: naciyevardar@yahoo.com
-
Sub-Investigator:
- Ebru Calik-Kutukcu, PhD
-
Sub-Investigator:
- Deniz Inal-Ince, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for Obstructive Lung Diseases
- 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.
Exclusion Criteria for Obstructive Lung Diseases:
- 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.
Inclusion Criteria for Healthy People 1.18-65 years of age, 2. Volunteer to participate in the research, 3. To be able to walk and cooperate.
Exclusion Criteria for Healthy People
- Having any cardiopulmonary disease,
- To have an advanced orthopedic disease that may affect functional capacity measurement and gait patterns.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Obstructive lung diseases group
|
|
Healthy group
Age and sex matched healthy subjects without orthopedic and chronic diseases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gait parameters
Time Frame: 01.09.2020-08.07.2021
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Balance and Fall Risk
Time Frame: 01.09.2020-08.07.2021
|
Timed Up and Go Test
|
01.09.2020-08.07.2021
|
|
Respiratory Muscle Strength
Time Frame: 01.09.2020-08.07.2021
|
Respiratory muscle strength parameters (maximal inspiratory and maximal expiratory pressure) measurement using mouth pressure device
|
01.09.2020-08.07.2021
|
|
Peripheral Muscle Strength
Time Frame: 01.09.2020-08.07.2021
|
Muscle strength of the knee extensors, hip extensors, shoulder abductors, trunk flexors and trunk extensors will be evaluated by hand dynamometer (Lafayette Manual Muscle Tester Model 01165-USA).
Jamar Hand Dynamometer (USA) will measure the hand grip force
|
01.09.2020-08.07.2021
|
|
Cognitive Status
Time Frame: 01.09.2020-08.07.2021
|
Mini Mental Test
|
01.09.2020-08.07.2021
|
|
Functional Exercise Capacity
Time Frame: 01.09.2020-08.07.2021
|
6 minute walking test with Moxy device on M.Vastus Lateralis
|
01.09.2020-08.07.2021
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naciye Vardar-Yagli, PhD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 19/665
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gait Disorder, Sensorimotor
-
Kirsehir Ahi Evran UniversitesiCompleted
-
Swiss Federal Institute of TechnologyBalgrist University HospitalCompletedGait Disorder, SensorimotorSwitzerland
-
Ludwig-Maximilians - University of MunichCompletedSensorimotor Gait DisorderGermany
-
Hangang Sacred Heart HospitalNot yet recruiting
-
Hangang Sacred Heart HospitalMinistry of Health, Republic of KoreaCompletedBurns | Gait Disorder, SensorimotorKorea, Republic of
-
Hangang Sacred Heart HospitalNot yet recruitingGait Disorder, Sensorimotor | Septic Arthritis
-
Medipol UniversityUniversity of Ljubljana; Moor Orthotics and ProstheticsActive, not recruitingAdolescent Idiopathic Scoliosis | Gait Disorder, SensorimotorSlovenia
-
University of PittsburghNational Institute on Aging (NIA)CompletedGait Disorder, Sensorimotor | Cognitive DisorderUnited States
-
Centre Hospitalier Universitaire de Saint EtienneCompletedSensorimotor DisorderFrance