Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease

Conditions
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Interstitial Lung Disease

Intervention / Treatment
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* Other: NMES Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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...)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NMES Group<br>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. | Other: NMES Group<br>* Neuromuscular electrical stimulation<br>|
| Sham Comparator: Control Group<br>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. | Other: Control Group<br>* Breathing exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | Six minute walk test | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary functions | Spirometry | 6 weeks | 
| Inspiratory and expiratory muscle strength (MIP,MEP) | Mouth pressure device | 6 weeks | 
| Dyspnea | Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales | 6 weeks | 
| Peripheral muscle strength | Hand held dynamometer | 6 weeks | 
| Maximal exercise capacity | Incremental shuttle walk test | 6 weeks | 
| Fatigue | Fatigue Severity Scale | 6 weeks | 
| Physical activity | Metabolic holter | 6 weeks | 
| Cough related quality of life | Leicester Cough Questionnaire | 6 weeks | 
| Depression | Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales) | 6 weeks | 
| Generic quality of life | Short Form (SF-36) Health Survey | 6 weeks | 
| Disease specific quality of life | Saint George Quality of Life Questionnaire | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial lung disease, neuromuscular electrical stimulation, exercise capacity, quality of life