Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

March 28, 2022 updated by: Meral Boşnak Güçlü, Gazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06500
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Chair: Meral Boşnak-Güçlü, PhD, Gazi University
  • Study Director: Burcu Camcıoğlu, MSc, Gazi University
  • Principal Investigator: Deran Oskay, PhD, Gazi University
  • Principal Investigator: Haluk Türktaş, Dr, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 15, 2015

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

December 30, 2018

Study Registration Dates

First Submitted

July 8, 2015

First Submitted That Met QC Criteria

July 10, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gazi University3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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