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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional exercise capacity
Time Frame: 6 weeks
Six minute walk test
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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