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Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

Primary Purpose

Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
NMES Group
Control Group
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Interstitial Lung Disease focused on measuring interstitial lung disease, neuromuscular electrical stimulation, exercise capacity, quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with interstitial lung disease
  • Clinically stable
  • Under standard medication
  • Having no exacerbation or infection

Exclusion Criteria:

  • Cognitive disorders
  • Orthopedic and neurological problems
  • Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)

Sites / Locations

  • Gazi University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

NMES Group

Control Group

Arm Description

Intervention: NMES group will receive neuromuscular electrical stimulation using high frequency galvanic stimulation and breathing exercises. Neuromuscular electrical stimulation will be applied bilaterally to quadriceps femoris muscle for 3days/6 weeks by a physiotherapist. NMES group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.

Sham: Control group will receive breathing exercises. Control group will perform breathing exercises 120 times/day, 7 days/week, for 6 weeks. Control group will be followed-up by telephone once a week.

Outcomes

Primary Outcome Measures

Functional exercise capacity
Six minute walk test

Secondary Outcome Measures

Pulmonary functions
Spirometry
Inspiratory and expiratory muscle strength (MIP,MEP)
Mouth pressure device
Dyspnea
Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales
Peripheral muscle strength
Hand held dynamometer
Maximal exercise capacity
Incremental shuttle walk test
Fatigue
Fatigue Severity Scale
Physical activity
Metabolic holter
Cough related quality of life
Leicester Cough Questionnaire
Depression
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
Generic quality of life
Short Form (SF-36) Health Survey
Disease specific quality of life
Saint George Quality of Life Questionnaire

Full Information

First Posted
July 8, 2015
Last Updated
March 28, 2022
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT02497144
Brief Title
Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease
Official Title
Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 15, 2015 (undefined)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception and hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired ventilatory response, increased lung compliance, ventilation-perfusion mismatching and inadequate peripheral circulation causes decreased exercise capacity. Another important factor that induce decreased exercise capacity is peripheral muscle weakness. In literature, there is no study investigated effects of neuromuscular electrical stimulation on functional exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity level, dyspnea and fatigue perception in patients with interstitial lung disease.
Detailed Description
In literature, there was increased quantity of study investigated effects of neuromuscular electrical stimulation in chronic lung disease patients. It was used as a pulmonary rehabilitation component especially in patients with decreased exercise capacity and peripheral muscle strength, intensely increased dyspnea inhibits exercise. It was demonstrated that neuromuscular electrical stimulation improved functional exercise capacity, peripheral muscle strength and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
interstitial lung disease, neuromuscular electrical stimulation, exercise capacity, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NMES Group
Arm Type
Active Comparator
Arm Description
Intervention: NMES group will receive neuromuscular electrical stimulation using high frequency galvanic stimulation and breathing exercises. Neuromuscular electrical stimulation will be applied bilaterally to quadriceps femoris muscle for 3days/6 weeks by a physiotherapist. NMES group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Sham: Control group will receive breathing exercises. Control group will perform breathing exercises 120 times/day, 7 days/week, for 6 weeks. Control group will be followed-up by telephone once a week.
Intervention Type
Other
Intervention Name(s)
NMES Group
Intervention Description
Neuromuscular electrical stimulation
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Breathing exercises
Primary Outcome Measure Information:
Title
Functional exercise capacity
Description
Six minute walk test
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pulmonary functions
Description
Spirometry
Time Frame
6 weeks
Title
Inspiratory and expiratory muscle strength (MIP,MEP)
Description
Mouth pressure device
Time Frame
6 weeks
Title
Dyspnea
Description
Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales
Time Frame
6 weeks
Title
Peripheral muscle strength
Description
Hand held dynamometer
Time Frame
6 weeks
Title
Maximal exercise capacity
Description
Incremental shuttle walk test
Time Frame
6 weeks
Title
Fatigue
Description
Fatigue Severity Scale
Time Frame
6 weeks
Title
Physical activity
Description
Metabolic holter
Time Frame
6 weeks
Title
Cough related quality of life
Description
Leicester Cough Questionnaire
Time Frame
6 weeks
Title
Depression
Description
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
Time Frame
6 weeks
Title
Generic quality of life
Description
Short Form (SF-36) Health Survey
Time Frame
6 weeks
Title
Disease specific quality of life
Description
Saint George Quality of Life Questionnaire
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with interstitial lung disease Clinically stable Under standard medication Having no exacerbation or infection Exclusion Criteria: Cognitive disorders Orthopedic and neurological problems Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meral Boşnak-Güçlü, PhD
Organizational Affiliation
Gazi University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Burcu Camcıoğlu, MSc
Organizational Affiliation
Gazi University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Müşerrefe N Karadallı, MSc
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deran Oskay, PhD
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haluk Türktaş, Dr
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
15653996
Citation
Swigris JJ, Gould MK, Wilson SR. Health-related quality of life among patients with idiopathic pulmonary fibrosis. Chest. 2005 Jan;127(1):284-94. doi: 10.1378/chest.127.1.284.
Results Reference
result
PubMed Identifier
12917227
Citation
Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.
Results Reference
result
PubMed Identifier
15618580
Citation
Spruit MA, Thomeer MJ, Gosselink R, Troosters T, Kasran A, Debrock AJ, Demedts MG, Decramer M. Skeletal muscle weakness in patients with sarcoidosis and its relationship with exercise intolerance and reduced health status. Thorax. 2005 Jan;60(1):32-8. doi: 10.1136/thx.2004.022244.
Results Reference
result
PubMed Identifier
18360183
Citation
Vivodtzev I, Lacasse Y, Maltais F. Neuromuscular electrical stimulation of the lower limbs in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil Prev. 2008 Mar-Apr;28(2):79-91. doi: 10.1097/01.HCR.0000314201.02053.a3.
Results Reference
result
PubMed Identifier
12454299
Citation
Bourjeily-Habr G, Rochester CL, Palermo F, Snyder P, Mohsenin V. Randomised controlled trial of transcutaneous electrical muscle stimulation of the lower extremities in patients with chronic obstructive pulmonary disease. Thorax. 2002 Dec;57(12):1045-9. doi: 10.1136/thorax.57.12.1045.
Results Reference
result
PubMed Identifier
19363213
Citation
Sillen MJH, Speksnijder CM, Eterman RA, Janssen PP, Wagers SS, Wouters EFM, Uszko-Lencer NHMK, Spruit MA. Effects of neuromuscular electrical stimulation of muscles of ambulation in patients with chronic heart failure or COPD: a systematic review of the English-language literature. Chest. 2009 Jul;136(1):44-61. doi: 10.1378/chest.08-2481. Epub 2009 Apr 10.
Results Reference
result

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Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

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