Effect of Core Stabilization Exercises and Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

NCT04197791 | Unknown

• 1 other identifier: 272303
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial lung disease (ILD) refers to various diseases that occur idiopathic or secondary to some causes, commonly affecting the lung parenchyma, and present with varying degrees of inflammation and fibrosis. Idiopathic pulmonary fibrosis (IPF) progressing with progressive shortness of breath causes a decrease in exercise capacity and quality of life, restrictive changes in pulmonary function tests and a decrease in diffusion capacity. It has been reported that core stabilization exercises improve respiratory function, respiratory muscle strength and functional capacity in healthy individuals and some disease groups. It has also been reported that neuromuscular electrical stimulation (NMES) applied to lower extremity, upper extremity and back or quadriceps muscles reduces dynamic hyperinflation and dyspnea during exercise and increases exercise capacity in COPD patients.No studies have been performed using core stabilization exercises and NMES in IPF patients. It can be assumed that this therapeutic intervention may also be useful in IPF. Our study was planned to investigate the efficacy of core stabilization exercises and NMES in patients with IPF.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Core Stabilization Exercises

Outcome Measures

Primary Outcomes (7)

• Forced Vital Capacity (FVC)

  Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 6 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Baseline and 6 weeks

• Forced Expiratory Volume 1 second (FEV1)

  Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function . FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Baseline and 6 weeks

• Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)

  Change from baseline FEV1 / FVC in respiratory function test at 6 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Baseline and 6 weeks

• Forced Expiratory flow from between 25% to 75% of Vital Capacity (FEF 25-75)

  Forced expiratory flow at 25-75% of FVC \[FEF25-75\] (L/sec) was measured with lung spirometry as it was described for FVC, FEV1, FEV1 / FVC measurements.

  Baseline and 6 weeks

• Peak flow rate (PEF)

  Change from baseline Peak flow rate (PEF) in respiratory function test at 6 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Baseline and 6 weeks

• Single-breath Diffusing Capacity for Carbon Monoxide (DLCO)

  The DLCO is a pulmonary function test that measures the capacity for the lung to carry out gas exchange between the inhaled breath and the pulmonary capillary blood vessels and the DLCO %-predicted represents the DLCO expressed as a percentage of the expected normal valued based on the participant's age, height, gender and ethnicity. The DLCO %-predicted is reduced in patients with interstitial lung disease and is used as a measure of disease severity.

  Baseline and 6 weeks

• Functional capacity

  Change from baseline functional capacity test at 6 weeks. Functional capacity will be assessed by the 6 minute walking test. The test will be performed according to American Thoracic Society (ATS) criteria. Patients will be allowed to rest for 10 minutes before the test. Heart rate, blood pressure, respiratory frequency, oxygen saturation, fatigue and dyspnea perception will be recorded before and after the test. Walking distance will be calculated.

  Baseline and 6 weeks

Secondary Outcomes (7)

• Maximum Inspiratory Pressure (MIP)

  Baseline and 6 weeks

• Maximum Expiratory Pressure (MEP)

  Baseline and 6 weeks

• Physical Activity

  Baseline and 6 weeks

• Change from baseline quality of life: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)

  Baseline and 6 weeks

• Change from baseline quality of life: Hospital Anxiety and Depression Scale (HADS)

  Baseline and 6 weeks

Study Arms (2)

Neuromuscular Electrical Stimulation (NMES)

EXPERIMENTAL

Neuromuscular Electrical Stimulation will be applied to 18 patients with idiopathic pulmonary fibrosis. The application time will be 30 minutes. Treatment will be programmed for 2 days per week. The program will continue for 6 weeks.

Device: Neuromuscular Electrical Stimulation

Core Stabilization Exercises

EXPERIMENTAL

Core stabilization exercises will be applied to 18 patients with idiopathic pulmonary fibrosis. The exercise time will be 30 minutes. Treatment will be programmed for 2 days per week. The program will continue for 6 weeks.

Other: Core Stabilization Exercises

Interventions

Neuromuscular Electrical Stimulation DEVICE

Neuromuscular Electrical Stimulation(NMES) to core stabilization muscles will be applied using 8 electrodes. The application time will be 30 minutes. Treatment will be programmed for 2 days per week. The program will continue for 6 weeks.

Neuromuscular Electrical Stimulation (NMES)

Core Stabilization Exercises OTHER

Warm-up and cool-down exercises will be performed before and after core stabilization exercises. The exercise time will be 30 minutes. Treatment will be programmed for 2 days per week. The program will continue for 6 weeks.

Core Stabilization Exercises

Eligibility Criteria

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

You may qualify if:

• Clinically stable
• Having no infection or exacerbation in the last 3 months
• Having no uncontrolled cardiological, psychological problems
• Having no neoplasm, sarcoidosis or collagen vascular diseases
• Having no neurological, inner ear or orthopedic disease
• Patients who volunteered to study

You may not qualify if:

• Over 75 years,
• Chronic obstructive pulmonary disease (COPD)
• Acute coronary artery disease,
• Collagen vascular disease,
• Pneumoconiosis,
• Sarcoidosis,
• Cancer
• Non-parenchymal restrictive lung disease and other serious comorbid conditions,
• Oxygen saturation in room air at rest \<80%
• During acute exacerbation,
• Echocardiography RVSP\> 50 mmHg
• Patients taking more than 20mg corticosteroid per day
• Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• Vainshelboim B, Oliveira J, Yehoshua L, Weiss I, Fox BD, Fruchter O, Kramer MR. Exercise training-based pulmonary rehabilitation program is clinically beneficial for idiopathic pulmonary fibrosis. Respiration. 2014;88(5):378-88. doi: 10.1159/000367899. Epub 2014 Oct 23.

  PMID: 25341682 BACKGROUND

• Park M, Seok H, Kim SH, Noh K, Lee SY. Comparison Between Neuromuscular Electrical Stimulation to Abdominal and Back Muscles on Postural Balance in Post-stroke Hemiplegic Patients. Ann Rehabil Med. 2018 Oct;42(5):652-659. doi: 10.5535/arm.2018.42.5.652. Epub 2018 Oct 31.

  PMID: 30404414 BACKGROUND

• Mustafaoglu R, Demir R, Demirci AC, Yigit Z. Effects of core stabilization exercises on pulmonary function, respiratory muscle strength, and functional capacity in adolescents with substance use disorder: Randomized controlled trial. Pediatr Pulmonol. 2019 Jul;54(7):1002-1011. doi: 10.1002/ppul.24330. Epub 2019 Apr 26.

  PMID: 31026384 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rengin Demir, Prof

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 13, 2019
• Study Start: December 10, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 16, 2019

Record last verified: 2019-12

Locations

TU (1)