Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease

NCT02497144 | Completed

• 1 other identifier: Gazi University3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Keywords

interstitial lung disease; neuromuscular electrical stimulation; exercise capacity; quality of life

Outcome Measures

Primary Outcomes (1)

• Functional exercise capacity

  Six minute walk test

  6 weeks

Secondary Outcomes (11)

• Pulmonary functions

  6 weeks

• Inspiratory and expiratory muscle strength (MIP,MEP)

  6 weeks

• Dyspnea

  6 weeks

• Peripheral muscle strength

  6 weeks

• Maximal exercise capacity

  6 weeks

Study Arms (2)

NMES Group

ACTIVE COMPARATOR

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.

Other: NMES Group

Control Group

SHAM COMPARATOR

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.

Other: Control Group

Interventions

NMES Group OTHER

Neuromuscular electrical stimulation

NMES Group

Control Group OTHER

Breathing exercises

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with interstitial lung disease
• Clinically stable
• Under standard medication
• Having no exacerbation or infection

You may not qualify if:

• Cognitive disorders
• Orthopedic and neurological problems
• Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University

Ankara, 06500, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 15653996 RESULT

• 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.

  PMID: 12917227 RESULT

• 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.

  PMID: 15618580 RESULT

• 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.

  PMID: 18360183 RESULT

• 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.

  PMID: 12454299 RESULT

• 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.

  PMID: 19363213 RESULT

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Meral Boşnak-Güçlü, PhD

  Gazi University

  STUDY CHAIR

• Burcu Camcıoğlu, MSc

  Gazi University

  STUDY DIRECTOR

• Müşerrefe N Karadallı, MSc

  Gazi University

  PRINCIPAL INVESTIGATOR

• Deran Oskay, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Haluk Türktaş, Dr

  Gazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 14, 2015
• Study Start: July 15, 2015
• Primary Completion: September 30, 2018
• Study Completion: December 30, 2018
• Last Updated: April 6, 2022

Record last verified: 2022-03

Locations

TU (1)