Respiratory Muscle Function, Diaphragm Thickness and Health Related Physical Fitness Parameters in Individuals

NCT04995510 | Unknown

• 1 other identifier: AIBU-FTR-ETY-01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In the literature, studies evaluating respiratory muscle function, diaphragm thickness and health-related physical fitness parameters together are insufficient in individuals with chronic obstructive pulmonary disease. In the thesis study, it is thought that the respiratory muscle function, diaphragm thickness, health-related physical fitness parameters, physical activity and lung functions of individuals with chronic obstructive pulmonary disease can be evaluated together to contribute to the literature. The aim of this study is to evaluate diaphragm thickness, respiratory muscle strength, endurance, body composition, aerobic exercise capacity, upper and lower extremity muscle strength and endurance, grip strength, flexibility in individuals with chronic obstructive pulmonary disease and compare them with the healthy group.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; diaphragm thickness; respiratory muscle function; body composition; physical fitness

Outcome Measures

Primary Outcomes (2)

• Diaphragm Thickness

  Diaphragm thickness will be measured by ultrasound. Diaphragm thickness will be measured twice, when the person fully exhales and fully fills their lungs with air. Diaphragm thickness will be measured at the 8th or 9th intercostal space. Decreased diaphragm thickness indicate impaired respiratory muscle function; being in the normal range indicates good respiratory muscle function.

  5 minutes

• Diaphragm Mobility

  Diaphragm mobility will be measured by ultrasound. Diaphragm mobility will be done by using the total amount of movement of the diaphragm until the individual breathes completely from the point of exhalation. Diaphragm mobility will be performed at the intersection of the medial axillary line and the costal line. Decreased diaphragm mobility indicate impaired respiratory muscle function; being in the normal range indicates good respiratory muscle function.

  5 minutes

Secondary Outcomes (16)

• Measurement of Maximal Inspiratory Pressure

  5 minutes

• Incremental Threshold Load Endurance Test

  10 minutes

• Pulmonary Function Test

  5 minutes

• Six Minute Walk Test

  10 minutes

• Body Composition: Lean Body Mass Percentage

  2 minutes

Study Arms (2)

Chronic Obstructive Pulmonary Disease Group

Individuals diagnosed with chronic obstructive pulmonary disease by ''Bolu Abant Izzet Baysal University'' Faculty of Medicine, Department of Chest Diseases and referred to the Physiotherapy and Rehabilitation Department of Bolu Abant Izzet Baysal University Health Sciences Faculty

Other: Observational

Healthy Group

Volunteer healthy individuals with similar demographic characteristics and without any diagnosed disease will be recruited

Other: Observational

Interventions

Observational OTHER

To evaluate your chronic obstructive pulmonary disease with Chronic Obstructive Pulmonary Disease assessment test, respiratory muscle strength with intraoral pressure measurement device, respiratory muscle endurance with increasing threshold load respiratory muscle endurance test, diaphragm thickness with ultrasound device, cardiorespiratory fitness with 6 Minute Walk Test, flexibility trunk lateral flexion test , back scratch test and sit and lie down test, muscle strength and endurance will be evaluated with push-up test, sit-up test, sit and stand test and hand grip strength, body composition will be evaluated by bioelectrical impedance analysis, physical activity will be questioned with the International Physical Activity Assessment Questionnaire, shortness of breath with the Mmrc Dyspnea Scale, and perception of fatigue and shortness of breath with the Modified Borg Scale.

Chronic Obstructive Pulmonary Disease Group; Healthy Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease characterized by persistent airflow limitation, usually progressive, associated with an increased chronic inflammatory response of the airways and lung to noxious gases and particles. In addition, healthy individuals in a similar age range without a diagnosed disease and symptoms will be included in the study.

You may qualify if:

• Individuals diagnosed with chronic obstructive pulmonary disease
• Be between the ages of 40-65
• No medication changes due to acute exacerbation for at least three weeks
• Be stable
• Volunteering to participate in research
• To cooperate
• Patients with written consent form
• Healthy individuals in a similar age range without a diagnosed disease and symptoms will be included

You may not qualify if:

• Those with a history of chronic obstructive pulmonary disease exacerbations
• Individuals with orthopedic disease
• Individuals with neurological disease
• Individuals with other co-existing lung and systemic diseases other than chronic obstructive pulmonary disease
• Those who have had major surgery in the past few months
• Individuals with a history of recurrent significant clinical infections
• Have cognitive problems
• Having had unstable angina,
• Previous Myocardial Infarction
• Individuals with severe congestive heart failure refractory to medical therapy, individuals with uncontrolled hypertension
• Individuals with cancer

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant İzzet Baysal University Department of Physiotherapy and Rehabilitation

Bolu, 14000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Eylem TÜTÜN YÜMİN, Assoc. Prof.

CONTACT

05056763191; eylemtutun78@hotmail.com

Ceyhun TOPCUOĞLU, Res. Assist.

CONTACT

05356535137; ceyhuntopcuoglu1@gmail.com

Study Design

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

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: August 9, 2021
• Study Start: July 12, 2021
• Primary Completion: September 27, 2021
• Study Completion: December 18, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)