Assessment of Pulmonary Functions and Peripheral Muscle Strength of COPD Patients in Different GOLD Stages

NCT04803656 | Completed

• 1 other identifier: SAG-C-YLP-131217-0652
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research was to examine the respiratory functions, respiratory muscle strength and peripheral muscle strength of patients with COPD in different groups and to evaluate their correlation with the duration and prognosis of the disease in COPD.

Conditions

Copd

Keywords

COPD; Pulmonary functions; Respiratory muscle strength; Peripheral muscle strength

Outcome Measures

Primary Outcomes (4)

• Respiratory Muscle Strength

  It is a non-invasive test that indirectly demonstrates respiratory muscle strength with maximal inspiratory pressure (PImax) and maximal expiratory pressure (PEmax).Test were carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.

  10 minutes after obtaining socio-demographic information (It was done between the 10th and 20th minutes of the assessment).

• Peripheral Muscle Strength Assessment-Upper extremity

  Upper extremity: For grip strength test a manual hydraulic dynamometer was used according to the recommendations of the American Association of Hand Therapists (AETD). The patients were measured in sitting position, shoulder adduction at 90 °, elbow flexion, forearm in pronosupination, neutral and wrist joints in neutral position. Three consecutive measurements were obtained by giving 60-second rest breaks between measurements. The result obtained from the average of three measurements was recorded.

  25 minutes after obtaining socio-demographic information. After the respiratory muscle strength evaluation, the patients were rested for 5 minutes (It was done between the 25th and 35th minutes of the assessment).

• Peripheral Muscle Strength Assessment-Lower extremity

  M. Quadriceps femoris strength was evaluated for knee extension. M. Hamstring strength was evaluated for knee flexion. The test was applied with the "make test" technique that requires isometric contraction. Participant was asked to maintain maximum isometric contraction for 5 seconds, and the average of 3 consecutive maximum contraction measurements performed at 30-second intervals was recorded.

  40 minutes after obtaining socio-demographic information. After Upper extremity muscle strength evaluation patients were rested for five minutes (It was done between the 40th and 55th minutes of the assessment)

• Pulmonary Function Test (PFT) results

  The PFT results of patients' performed during their routine controls taken into consideration. The percentages of the predicted values (percent) for forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC, mid-expiratory flow rate (MEF25-75) and peak expiratory flow (PEF) were used for statistical analysis.

  55 minutes after obtaining socio-demographic information.

Secondary Outcomes (3)

• Duration of the disease

  After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.

• Exacerbation numbers in last one year

  After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.

• Hospitalization numbers in last one year

  After the permission of patients, in the first 10 minutes of assessment while obtaining socio-demographic information of patients.

Study Arms (1)

Assesment

OTHER

Demographic information of all subjects (age, gender, educational status, occupation, body weight, height, body mass index), clinical (diagnosis period) and medical status, personal history and family history, COPD stage, COPD Assessment Test (CAT) score, emergency and hospital admissions numbers in the last 3 months, exacerbation and hospitalization numbers in the last one year were recorded. Respiratory and peripheral muscle strengths are evaluated. Also pulmonary functions test results obtained.

Other: Assessment of COPD patients

Interventions

Assessment of COPD patients OTHER

Assessments explained in the arm section were made as described in one session.

Assesment

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being in COPD stable period and over the age of 40,
• The absence of abnormal laboratory findings,
• Not having a mental problem that prevents filling the questionnaires to be used in the study, - The absence of any other respiratory disease such as asthma,
• Giving the informed consent.

You may not qualify if:

• COPD exacerbation (hospitalization with acute exacerbation in the last 15 days),
• Presence of cognitive impairment,
• Pregnancy status,
• Ischemic heart disease,
• Kyphoscoliosis and advanced postural disorder,
• Orthopedic problems and amputation surgery,
• Emphysema, bullous lung disease,
• Presence of bronchiectasis,
• Previous thoracic surgery history,
• Presence of lung cancer,
• Advanced heart failure.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Begum Unlu, PT, MSc

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: COPD patients: Respiratory muscle strength, peripheral muscle strength in both upper and lower extremity were evaluated. Pulmonary function tests obtained during routine controls of patients.

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 18, 2021
• Study Start: February 8, 2019
• Primary Completion: May 23, 2019
• Study Completion: June 19, 2019
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)