Clinical trial NCT04197791: Effect of Core Stabilization Exercises and Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis
Official title: Effect of Core Stabilization Exercises and Neuromuscular Electrical Stimulation (NMES) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Core Stabilization Exercises
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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...)

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: Baseline and 6 weeks
measure: Forced Expiratory Volume 1 second (FEV1)
timeFrame: Baseline and 6 weeks
measure: Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)
timeFrame: Baseline and 6 weeks
measure: Forced Expiratory flow from between 25% to 75% of Vital Capacity (FEF 25-75)
timeFrame: Baseline and 6 weeks
measure: Peak flow rate (PEF)
timeFrame: Baseline and 6 weeks
measure: Single-breath Diffusing Capacity for Carbon Monoxide (DLCO)
timeFrame: Baseline and 6 weeks
measure: Functional capacity
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Maximum Inspiratory Pressure (MIP)
timeFrame: Baseline and 6 weeks
measure: Maximum Expiratory Pressure (MEP)
timeFrame: Baseline and 6 weeks
measure: Physical Activity
timeFrame: Baseline and 6 weeks
measure: Change from baseline quality of life: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
timeFrame: Baseline and 6 weeks
measure: Change from baseline quality of life: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 6 weeks
measure: The Fatigue Severity Scale
timeFrame: Baseline and 6 weeks
measure: Timed up and go test
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Rengin Demir, Prof
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.