MedDataX Logo

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

NCT ID: NCT04197791

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Fibrosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Core Stabilization Exercises

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Core Stabilization Exercises

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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...)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

ELÇİN ÇAKIR

MSc student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rengin Demir, Prof

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25341682 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30404414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31026384 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

272303

Identifier Type: -

Identifier Source: org_study_id