Interstitial Lung DiseaseNCT02497144
Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease
A study testing NMES Group in people with Interstitial Lung Disease, run by Gazi University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- NMES Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2015to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with interstitial lung disease
- Clinically stable
- Under standard medication
- Having no exacerbation or infection
Who cannot join
- Cognitive disorders
- Orthopedic and neurological problems
- Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease
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.
Read the 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.
- Conditions
- Interstitial Lung Disease
- Being tested
- NMES Group, Control Group
- Keywords
- interstitial lung disease, neuromuscular electrical stimulation, exercise capacity, quality of life
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMES GroupOther
Neuromuscular electrical stimulation
Control GroupOther
Breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional exercise capacity
Six minute walk test
Measured: 6 weeks
Secondary outcomes (11)
Pulmonary functions
Spirometry
Measured: 6 weeks
Inspiratory and expiratory muscle strength (MIP,MEP)
Mouth pressure device
Measured: 6 weeks
Dyspnea
Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales
Measured: 6 weeks
Peripheral muscle strength
Hand held dynamometer
Measured: 6 weeks
Maximal exercise capacity
Incremental shuttle walk test
Measured: 6 weeks
Fatigue
Fatigue Severity Scale
Measured: 6 weeks
Physical activity
Metabolic holter
Measured: 6 weeks
Cough related quality of life
Leicester Cough Questionnaire
Measured: 6 weeks
Depression
Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
Measured: 6 weeks
Generic quality of life
Short Form (SF-36) Health Survey
Measured: 6 weeks
Disease specific quality of life
Saint George Quality of Life Questionnaire
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start15 Jul 2015
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral Boşnak-Güçlü, PhD, Study chair, Gazi UniversityBurcu Camcıoğlu, MSc, Study director, Gazi UniversityMüşerrefe N Karadallı, MSc, Principal investigator, Gazi UniversityDeran Oskay, PhD, Principal investigator, Gazi UniversityHaluk Türktaş, Dr, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497144
- Sponsor's protocol ID
- Gazi University3
- Status last verified
- Mar 2022
- First submitted
- 8 Jul 2015
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15653996Lama 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.
PubMed 12917227Spruit 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.
PubMed 15618580Vivodtzev 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.
PubMed 18360183Bourjeily-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.
PubMed 12454299Sillen 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.
PubMed 19363213Camcioglu Yilmaz B, Bosnak Guclu M, Keles MN, Oskay D, Turktas H. Effects of neuromuscular electrical stimulation on exercise capacity, muscle strength, physical activity, and quality of life in patients with interstitial lung diseases: A randomized study. Respir Med. 2025 Nov;248:108360. doi: 10.1016/j.rmed.2025.108360. Epub 2025 Sep 18.
PubMed 40975137
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT02497144
- Acronym / sponsor ID
- Gazi University3
- Conditions
- Interstitial Lung Disease
- Keywords
- interstitial lung disease, neuromuscular electrical stimulation, exercise capacity, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Jul 2015
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES Group | Active comparator | Other: NMES GroupIntervention: 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. |
| Control Group | Sham comparator | Other: Control GroupSham: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with interstitial lung disease
- Clinically stable
- Under standard medication
- Having no exacerbation or infection
Key exclusion criteria (3 listed)
- Cognitive disorders
- Orthopedic and neurological problems
- Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMES GroupNeuromuscular electrical stimulation | Other | NMES Group |
| Control GroupBreathing exercises | Other | Control Group |
Primary outcome
Functional exercise capacity
Time frame: 6 weeks
Six minute walk test
11 secondary outcomes
Pulmonary functions
Time frame: 6 weeks
Inspiratory and expiratory muscle strength (MIP,MEP)
Time frame: 6 weeks
Dyspnea
Time frame: 6 weeks
Peripheral muscle strength
Time frame: 6 weeks
Maximal exercise capacity
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Physical activity
Time frame: 6 weeks
Cough related quality of life
Time frame: 6 weeks
Depression
Time frame: 6 weeks
Generic quality of life
Time frame: 6 weeks
Disease specific quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Results publication: PubMed 15653996Swigris 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.
- Results publication: PubMed 12917227Lama 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.
- Results publication: PubMed 15618580Spruit 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.
- Results publication: PubMed 18360183Vivodtzev 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.
- Results publication: PubMed 12454299Bourjeily-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.
- Results publication: PubMed 19363213Sillen 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.
- Derived from this study: PubMed 40975137Camcioglu Yilmaz B, Bosnak Guclu M, Keles MN, Oskay D, Turktas H. Effects of neuromuscular electrical stimulation on exercise capacity, muscle strength, physical activity, and quality of life in patients with interstitial lung diseases: A randomized study. Respir Med. 2025 Nov;248:108360. doi: 10.1016/j.rmed.2025.108360. Epub 2025 Sep 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Boşnak-Güçlü, PhD study chair
Gazi University
Burcu Camcıoğlu, MSc study director
Gazi University
Müşerrefe N Karadallı, MSc principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES Group in people with Interstitial Lung Disease, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional exercise capacity (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02497144, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.