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Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

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ClinicalTrials.gov Identifier: NCT02497144
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Meral Boşnak Güçlü, Gazi University

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 Not Applicable

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  (Clinical Trial)
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 : July 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : July 2018


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




Primary Outcome Measures :
  1. Functional exercise capacity [ Time Frame: 6 weeks ]
    Six minute walk test


Secondary Outcome Measures :
  1. Pulmonary functions [ Time Frame: 6 weeks ]
    Spirometry

  2. Inspiratory and expiratory muscle strength (MIP,MEP) [ Time Frame: 6 weeks ]
    Mouth pressure device

  3. Dyspnea [ Time Frame: 6 weeks ]
    Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales

  4. Peripheral muscle strength [ Time Frame: 6 weeks ]
    Hand held dynamometer

  5. Maximal exercise capacity [ Time Frame: 6 weeks ]
    Incremental shuttle walk test

  6. Fatigue [ Time Frame: 6 weeks ]
    Fatigue Severity Scale

  7. Physical activity [ Time Frame: 6 weeks ]
    Metabolic holter

  8. Quality of life [ Time Frame: 6 weeks ]
    Leicester Cough Questionnaire

  9. Depression [ Time Frame: 6 weeks ]
    Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)

  10. Quality of life [ Time Frame: 6 weeks ]
    Short Form (SF-36) Health Survey

  11. Quality of life [ Time Frame: 6 weeks ]
    Saint George Quality of Life Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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...)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497144


Locations
Turkey
Gazi University
Ankara, Turkey, 06500
Sponsors and Collaborators
Gazi University
Investigators
Study Chair: Meral Boşnak-Güçlü, PhD Gazi University
Study Director: Burcu Camcıoğlu, MSc Gazi University
Principal Investigator: Müşerrefe N Karadallı, MSc Gazi University
Principal Investigator: Deran Oskay, PhD Gazi University
Principal Investigator: Haluk Türktaş, Dr Gazi University

Publications of Results:

Responsible Party: Meral Boşnak Güçlü, Assoc. Prof, Gazi University
ClinicalTrials.gov Identifier: NCT02497144     History of Changes
Other Study ID Numbers: Gazi University3
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018

Keywords provided by Meral Boşnak Güçlü, Gazi University:
interstitial lung disease
neuromuscular electrical stimulation
exercise capacity
quality of life

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases