Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05005533
Other study ID # AIBU-FTR-CT-05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2021
Est. completion date May 15, 2023

Study information

Verified date March 2023
Source Abant Izzet Baysal University
Contact Eylem TÜTÜN YÜMIN, Assoc. Prof.
Phone +90 505 676 31 91
Email eylemtutun78@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, suggestions will be made to help individual postural smoothness and improve physical performance.


Description:

Chronic Obstructive Pulmonary Disease is a multifaceted disease that results from the interaction between genetic susceptibility and exposure to environmental stimuli. Due to the slow progression and chronic nature of the disease, it creates a growing disease burden on the individual. Considering the data of the Turkish Statistical Institute, the third most common cause of death in Turkey in 2010, 2011 and 2012 was respiratory system diseases. 61.5% of respiratory system deaths in 2012 were due to Chronic Obstructive Pulmonary Disease. Due to the progressive airway obstruction that occurs in Chronic Obstructive Pulmonary Disease, the level of inspiratory muscle strength is restricted and there is an increasing deterioration in the level of functional performance. However, with increasing age, postural problems can be observed in individuals with Chronic Obstructive Pulmonary Disease. Postural problems such as rounded shoulders, increase in thoracic kyphosis and muscle shortness can be observed especially in patients who start to use the auxiliary respiratory muscles continuously due to inspiratory muscle strength. There are few articles investigating the changes in posture, physical performance and inspiratory muscles with the addition of a chronic disease such as Chronic Obstructive Pulmonary Disease to the normal aging process. For this reason, a study titled "The effect of respiratory muscle strength and functional capacity on posture and balance in individuals with Chronic Obstructive Pulmonary Disease with Different Phenotypes" was planned. As a result of the study, inspiratory muscle strength, posture and physical performance evaluations of individuals with Chronic Obstructive Pulmonary Disease will be made, and suggestions will be made to help individual postural smoothness and improve physical performance.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 15, 2023
Est. primary completion date February 15, 2023
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - Being diagnosed with Chronic Obstructive Pulmonary Disease according to the Global Initiative for Chronic Obstructive Lung Disease criteria - Not having vision, hearing and speech problems - Volunteering to participate in the research Exclusion Criteria: - Have had major surgery in the past few months - History of recurrent significant clinical infection - Having cognitive problems - Unstable angina, previous myocardial infarction (MI), - Severe congestive heart failure resistant to medical treatment, - Having uncontrolled hypertension, - Get cancer - Having neurological or musculoskeletal diseases with functional limitations - Having suffered an injury, such as a sprain, sprain or fracture of the lower extremity in the last 6 months, unable to perform independent ambulation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observational
Chronic Obstructive Pulmonary Disease Severity of Individuals by Chronic Obstructive Pulmonary Disease Assessment Test, shortness of breath Modified Medical Research Council scale, cough related quality of life Leicester Cough Questionnaire, respiratory muscle strength with Maximum Inspiratory and Expiratory Pressure, Posture with Spinal Mouse device, pain with Visual Analog Scale, severity of fatigue Fatigue Physical performance of the lower extremities will be evaluated with the Short Physical Performance Test, functional mobility will be evaluated with the Time Up and Go Test, and balance will be evaluated with the Biodex Balance System

Locations

Country Name City State
Turkey Bolu Abant Izzet Baysal University Department of Physiotherapy and Rehabilitation Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal Inspiratory Pressure Respiratory muscle strength will be assessed by maximal inspiratory pressure. Values in the normal range indicate normal respiratory muscle strength, low values indicate decreased respiratory muscle strength. 5 minutes
Secondary Posture Assessment Posture assessment of individuals will be done with the Spinal Mouse device. Individuals will be asked to distribute their weight equally on both lower extremities as much as possible and to stand symmetrically. The angular deviation between each SPINE will be calculated as an angle. While the high angle of deviation indicates that the posture is bad; A low angle of deviation indicates a good posture 5 minutes
Secondary Biodex Balance System Balance assessment will be evaluated with the Biodex Balance System. A high values indicates poor balance, and a low values indicates good balance. 5 minutes
Secondary Time Up and Go Test Time Up and Go Test is a balance test that is frequently used to evaluate the functional mobility of individuals. High times indicate impaired functional mobility; low times indicate good functional mobility. 2 minutes
Secondary Short Physical Performance Test The physical performance of the lower extremities of the individuals will be evaluated with the Short Physical Performance Test. High values indicate deterioration of physical performance; low values indicate good physical performance. 5 minutes
Secondary Chronic Obstructive Pulmonary Disease Assessment Test Chronic Obstructive Pulmonary Disease symptoms are assessed with the Chronic Obstructive Pulmonary Disease Evaluation Test. High values indicate poor health; low values indicate good health 2 minutes
Secondary Modified Medical Research Council Scale The breath assessment test will be evaluated with the Modified Medical Research Council Scale. High values indicate high dyspnea; low values indicate low dyspnea. 2 minutes
Secondary Leicester Cough Questionnaire The cough related quality of life questionnaire will be assessed by the Leicester Cough Questionnaire. Low values indicate poor quality of life associated with cough; high values indicate good quality of life associated with cough 2 minutes
Secondary Visual Analog Scale Pain intensity will be evaluated with a visual analog scale. While high values indicate increased pain intensity; low values indicate low pain intensity 2 minutes
Secondary Fatigue Severity Scale Fatigue will be evaluated with the Fatigue Severity Scale. High values indicate increased fatigue severity; lower values indicate lower fatigue severity 2 minutes
See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy