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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular Electrical Stimulation
Core Stabilization Exercises
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Idiopathic Pulmonary Fibrosis focused on measuring Core Stabilization Exercises

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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...)

Sites / Locations

  • Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neuromuscular Electrical Stimulation (NMES)

Core Stabilization Exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.
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.

Full Information

First Posted
December 9, 2019
Last Updated
December 13, 2019
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT04197791
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Core Stabilization Exercises

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular Electrical Stimulation (NMES)
Arm Type
Experimental
Arm Description
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.
Arm Title
Core Stabilization Exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
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
Other
Intervention Name(s)
Core Stabilization Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forced Vital Capacity (FVC)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Forced Expiratory Volume 1 second (FEV1)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Forced Expiratory Volume 1 second / Forced Vital Capacity (FEV1 / FVC)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Forced Expiratory flow from between 25% to 75% of Vital Capacity (FEF 25-75)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Peak flow rate (PEF)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Single-breath Diffusing Capacity for Carbon Monoxide (DLCO)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Functional capacity
Description
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.
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Maximum Inspiratory Pressure (MIP)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Maximum Expiratory Pressure (MEP)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Physical Activity
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from baseline quality of life: King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Change from baseline quality of life: Hospital Anxiety and Depression Scale (HADS)
Description
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).
Time Frame
Baseline and 6 weeks
Title
The Fatigue Severity Scale
Description
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.
Time Frame
Baseline and 6 weeks
Title
Timed up and go test
Description
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.
Time Frame
Baseline and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rengin Demir, Prof
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
25341682
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.
Results Reference
background
PubMed Identifier
30404414
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.
Results Reference
background
PubMed Identifier
31026384
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.
Results Reference
background

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

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