Clinical trial NCT02497144: Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease
Official title: Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interstitial Lung Disease
Keywords: interstitial lung disease
neuromuscular electrical stimulation
exercise capacity
quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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...)

Primary outcomes:
measure: Functional exercise capacity
timeFrame: 6 weeks
Secondary outcomes:
measure: Pulmonary functions
timeFrame: 6 weeks
measure: Inspiratory and expiratory muscle strength (MIP,MEP)
timeFrame: 6 weeks
measure: Dyspnea
timeFrame: 6 weeks
measure: Peripheral muscle strength
timeFrame: 6 weeks
measure: Maximal exercise capacity
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Physical activity
timeFrame: 6 weeks
measure: Cough related quality of life
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
measure: Generic quality of life
timeFrame: 6 weeks
measure: Disease specific quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Meral Boşnak-Güçlü, PhD
role: STUDY_CHAIR
affiliation: Gazi University
name: Burcu Camcıoğlu, MSc
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Müşerrefe N Karadallı, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Deran Oskay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Haluk Türktaş, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bourjeily-Habr G, Rochester CL, Palermo F, Snyder P, Mohsenin V. Randomised controlled trial of transcutaneous electrical muscle stimulation of the lower extremities in patients with chronic obstructive pulmonary disease. Thorax. 2002 Dec;57(12):1045-9. doi: 10.1136/thorax.57.12.1045.
citation: Sillen MJH, Speksnijder CM, Eterman RA, Janssen PP, Wagers SS, Wouters EFM, Uszko-Lencer NHMK, Spruit MA. Effects of neuromuscular electrical stimulation of muscles of ambulation in patients with chronic heart failure or COPD: a systematic review of the English-language literature. Chest. 2009 Jul;136(1):44-61. doi: 10.1378/chest.08-2481. Epub 2009 Apr 10.