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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02497144
Other study ID # Gazi University3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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...)

Study Design


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
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