Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

NCT ID: NCT02497144

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-15

Study Completion Date

2018-12-30

Brief Summary

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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

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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.

Conditions

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Interstitial Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

NMES Group

Intervention Type OTHER

Neuromuscular electrical stimulation

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.

Group Type SHAM_COMPARATOR

Control Group

Intervention Type OTHER

Breathing exercises

Interventions

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NMES Group

Neuromuscular electrical stimulation

Intervention Type OTHER

Control Group

Breathing exercises

Intervention Type OTHER

Eligibility Criteria

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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...)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Meral Boşnak Güçlü

Assoc. Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meral Boşnak-Güçlü, PhD

Role: STUDY_CHAIR

Gazi University

Burcu Camcıoğlu, MSc

Role: STUDY_DIRECTOR

Gazi University

Müşerrefe N Karadallı, MSc

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Deran Oskay, PhD

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Haluk Türktaş, Dr

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Swigris JJ, Gould MK, Wilson SR. Health-related quality of life among patients with idiopathic pulmonary fibrosis. Chest. 2005 Jan;127(1):284-94. doi: 10.1378/chest.127.1.284.

Reference Type RESULT
PMID: 15653996 (View on PubMed)

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 Nov 1;168(9):1084-90. doi: 10.1164/rccm.200302-219OC. Epub 2003 Aug 13.

Reference Type RESULT
PMID: 12917227 (View on PubMed)

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. doi: 10.1136/thx.2004.022244.

Reference Type RESULT
PMID: 15618580 (View on PubMed)

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.

Reference Type RESULT
PMID: 18360183 (View on PubMed)

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.

Reference Type RESULT
PMID: 12454299 (View on PubMed)

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.

Reference Type RESULT
PMID: 19363213 (View on PubMed)

Other Identifiers

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Gazi University3

Identifier Type: -

Identifier Source: org_study_id

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