Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497144
• Other study ID #: Gazi University3
• Status: Completed
• Phase: N/A
• Start date: July 15, 2015
• Est. completion date: December 30, 2018

Study information

• Verified date: March 2022
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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...)

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Other:
• NMES Group
Neuromuscular electrical stimulation
• Control Group
Breathing exercises

Locations

Country	Name	City	State
Turkey	Gazi University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Lama VN, Flaherty KR, Toews GB, Colby TV, Travis WD, Long Q, Murray S, Kazerooni EA, Gross BH, Lynch JP 3rd, Martinez FJ. Prognostic value of desaturation during a 6-minute walk test in idiopathic interstitial pneumonia. Am J Respir Crit Care Med. 2003 No — View 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 E — View Citation

Spruit MA, Thomeer MJ, Gosselink R, Troosters T, Kasran A, Debrock AJ, Demedts MG, Decramer M. Skeletal muscle weakness in patients with sarcoidosis and its relationship with exercise intolerance and reduced health status. Thorax. 2005 Jan;60(1):32-8. — View Citation

Swigris JJ, Gould MK, Wilson SR. Health-related quality of life among patients with idiopathic pulmonary fibrosis. Chest. 2005 Jan;127(1):284-94. Review. — View Citation

Vivodtzev I, Lacasse Y, Maltais F. Neuromuscular electrical stimulation of the lower limbs in patients with chronic obstructive pulmonary disease. J Cardiopulm Rehabil Prev. 2008 Mar-Apr;28(2):79-91. doi: 10.1097/01.HCR.0000314201.02053.a3. Review. — View Citation

Outcome

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