Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

Sponsor

Gazi University (Other)

Overall Status

Completed

CT.gov ID

NCT02497144

Collaborator

(none)

Enrollment

Location

Arms

41.5

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Lung Disease	Other: NMES Group Other: Control Group	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 15, 2015

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Dec 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: NMES Group 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 Neuromuscular electrical stimulation
Sham Comparator: Control Group 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 Breathing exercises

Arm

Intervention/Treatment

Active Comparator: NMES Group

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

Neuromuscular electrical stimulation

Sham Comparator: Control Group

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

Breathing exercises

Outcome Measures

Primary Outcome Measures

Functional exercise capacity [6 weeks]
Six minute walk test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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...)