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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062292
Other study ID # GO 19/665
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 29, 2021
Est. completion date May 27, 2022

Study information

Verified date October 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 27, 2022
Est. primary completion date May 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria for Obstructive Lung Diseases 1. Being diagnosed with obstructive lung disease, 2. Have not experienced acute exacerbation or infection in the last 1 week, 3. To be between 18-65 years, 4. Volunteering for research, 5. To be able to walk and cooperate. Exclusion Criteria for Obstructive Lung Diseases: 1. Use walking aid or be chronic oxygen support 2. To have orthopedic or neuromuscular comorbidities that may affect walking patterns. 3. 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 1. Having any cardiopulmonary disease, 2. To have an advanced orthopedic disease that may affect functional capacity measurement and gait patterns.

Study Design


Locations

Country Name City State
Turkey Naciye Vardar-Yagli Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Functional Balance and Fall Risk Timed Up and Go Test 01.09.2020-08.07.2021
Secondary Functional Exercise Capacity 6 minute walking test 01.09.2020-08.07.2021
Secondary Respiratory Muscle Strength Respiratory muscle strength parameters (maximal inspiratory and maximal expiratory pressure) measurement using mouth pressure device 01.09.2020-08.07.2021
Secondary Peripheral Muscle Strength 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
Secondary Activities of Daily Living Glittre-ADL test 01.09.2020-08.07.2021
Secondary Cognitive Status Mini Mental Test 01.09.2020-08.07.2021
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