Neuromuscular Electrical Stimulation in Patients With Interstitial Lung Disease
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|ClinicalTrials.gov Identifier: NCT02497144|
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : August 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Lung Disease||Other: NMES Group Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||July 2018|
Active Comparator: 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.
Other: NMES Group
Neuromuscular electrical stimulation
Sham Comparator: 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.
Other: Control Group
- Functional exercise capacity [ Time Frame: 6 weeks ]Six minute walk test
- Pulmonary functions [ Time Frame: 6 weeks ]Spirometry
- Inspiratory and expiratory muscle strength (MIP,MEP) [ Time Frame: 6 weeks ]Mouth pressure device
- Dyspnea [ Time Frame: 6 weeks ]Modified Borg and Modified Medical Research Council (MMRC) Dyspnea scales
- Peripheral muscle strength [ Time Frame: 6 weeks ]Hand held dynamometer
- Maximal exercise capacity [ Time Frame: 6 weeks ]Incremental shuttle walk test
- Fatigue [ Time Frame: 6 weeks ]Fatigue Severity Scale
- Physical activity [ Time Frame: 6 weeks ]Metabolic holter
- Quality of life [ Time Frame: 6 weeks ]Leicester Cough Questionnaire
- Depression [ Time Frame: 6 weeks ]Montgomery Asberg Depression Rating Scale (MADRS) (Turkish versions of all scales)
- Quality of life [ Time Frame: 6 weeks ]Short Form (SF-36) Health Survey
- Quality of life [ Time Frame: 6 weeks ]Saint George Quality of Life Questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497144
|Ankara, Turkey, 06500|
|Study Chair:||Meral Boşnak-Güçlü, PhD||Gazi University|
|Study Director:||Burcu Camcıoğlu, MSc||Gazi University|
|Principal Investigator:||Müşerrefe N Karadallı, MSc||Gazi University|
|Principal Investigator:||Deran Oskay, PhD||Gazi University|
|Principal Investigator:||Haluk Türktaş, Dr||Gazi University|