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OpenTrials
Completed

NCT Number: NCT02497144

Neuromuscular Electrical Stimulation 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.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, 06500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

NMES Group

Other

Neuromuscular electrical stimulation

Control Group

Other

Breathing exercises

Primary outcomes

  1. Functional exercise capacity

    Time frame: 6 weeks

    Six minute walk test

Secondary outcomes

  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. Cough related 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. Generic quality of life

    Time frame: 6 weeks

    Short Form (SF-36) Health Survey

  11. Disease specific quality of life

    Time frame: 6 weeks

    Saint George Quality of Life Questionnaire

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2015
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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