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

Effect of Core Stabilization Exercises and Neuromuscular Electrical Stimulation (NMES) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Device: Neuromuscular Electrical Stimulation; Other: Core Stabilization Exercises

Detailed Description

Stable idiopathic pulmonary fibrosis will be included in the study from the Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital. Patients will be randomized into 2 groups; Neuromuscular Electrical Stimulation (NMES) and Core Stabilization Exercises Training Group (n: 18): 2 days per week for 6 weeks duration. The demographic measurements, respiratory function test, respiratory muscle strength, dyspnea, 6 minutes walking test, quality of life, depression and clinical characteristics and physical fitness of the patients will be recorded. The following parameters will be evaluated before and after the training of the patients in the two groups.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neuromuscular Electrical Stimulation (NMES); 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; 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.
Experimental: Core Stabilization Exercises; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Inspiratory Pressure (MIP)	Change from baseline Maximum Inspiratory Pressure (MIP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MIP measurement is a non-invasive technique.	Baseline and 6 weeks
Maximum Expiratory Pressure (MEP)	Change from baseline Maximum Expiratory Pressure (MEP) at 6 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria. The most commonly used method for evaluating respiratory muscles is MEP measurement is a non-invasive technique.	Baseline and 6 weeks
Physical Activity	Change from baseline physical activity scores at 6 weeks. International Physical Activity Questionnaire (IPAQ) - Short Form (Turkish version of scale ).This questionnaire assesses, in minutes, the physical activity performed by the volunteers during the period of one week. The IPAQ considered all activities carried out by the volunteer (e.g. leisure, sport, exercise, and activities at home or in the garden). According to the responses, the volunteer is considered very active, active, irregularly active or sedentary, according to the intensity and time of the exercises practiced over the last week.	Baseline and 6 weeks
Change from baseline quality of life: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)	Quality of life will be measured with King's Brief Interstitial Lung Disease Questionnaire (K-BILD). It is a 15-item validated questionnaire assessing health status in patients with an interstitial lung disease. Questions are related to three domains: breathlessness and activities, psychological aspects, and chest symptoms. Each question has 7 possible answers. The questionnaire has a scale from 0 - 100, in which 100 means highest quality of life.	Baseline and 6 weeks
Change from baseline quality of life: Hospital Anxiety and Depression Scale (HADS)	Quality of life will be measured with the Hospital Anxiety and Depression Scale (HADS). It is a 14-item questionnaire, 7 items are related to depression and 7 items are related to anxiety. Each question has 4 different answer options, each scored from 0-3. Scores are summed up for each field (depression or anxiety) with 0 points as lowest possibility and 21 scores as highest (0-7 = normal, 8-10 = borderline abnormal, and 11-21 = abnormal).	Baseline and 6 weeks
The Fatigue Severity Scale	The Fatigue Severity Scale is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. Respondents answer using a Likert scale ranging from 1 to 7. ''1'' indicates strong disagreement with the statement, while ''7'' indicates strong agreement. Total score is calculated by deriving an arithmetic mean. FSS scores range from 0-63. A score of 36 or higher generally indicates severe fatigue.	Baseline and 6 weeks
Timed up and go test	Functional mobility was measured with Timed up and go test [TUGT] (sec). The patient sitting on chair stood up with the instruction of physiotherapist and walked 3 meters as fast as possible, walked back to the chair and sat down again. The total duration was recorded in seconds. Lower time reflects better functional mobility. TUGT was performed with 3 repetitions.	Baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Istanbul University-Cerrahpasa
• Investigators: Study Director: Rengin Demir, Prof, Istanbul University-Cerrahpasa

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Core Stabilization Exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 272303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No