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Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03890250
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
Istanbul University-Cerrahpasa
Istanbul University
Information provided by (Responsible Party):
Buket AKINCI, Biruni University

Brief Summary:
Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Neuromuscular Electrical Stimulation Other: Aerobic exercise Other: Neuromuscular electrical stimulation Not Applicable

Detailed Description:

Idiopathic pulmonary fibrosis (IPF) is a progressive, fibrotic interstitial lung disease characterized by progressive dyspnoea, reduced exercise capacity, quality of life, and classified as a rare disease. With the increase in medical treatment options, the progression of the disease slows down. Increased time of survival has increased the need for pulmonary rehabilitation programs that have been shown to be effective in patients' exercise capacity, participation in daily living activities, and improvement in the quality of life. Patients with IPF have been shown to be able to improve dyspnoea, fatigue, exercise capacity, daily living activities and quality of life with home-based or supervised breathing, posture, strengthening and aerobic/endurance exercise programs.

Pulmonary rehabilitation should be initiated and lifelong at the time of diagnosis for patients with IPF. However, the symptoms of the disease and its progression limit clinical options in terms of participation and sustainability in rehabilitation programs. For this purpose, patients with IPF need physiotherapy and rehabilitation options that will not increase the symptoms associated with exercise and contribute to the program in the long term. Neuromuscular electrical stimulation (NMES) is a rehabilitation option that can be applied to specific muscle groups without the ventilator and cardiac load especially in patients who can not actively exercise or have decreased muscle strength. In adult patients with an advanced disease characterized by reduced muscle strength, the use of NMES in addition to aerobic exercise programs is recommended as part of rehabilitation programs. In the literature, no studies investigating the efficacy of NMES have been found in individuals with IPF or interstitial lung disease. NMES application in addition to aerobic exercise seems to be a reasonable option when considering the symptoms of patients with IPF and the progression of the disease. The aim of this project is to investigate the efficacy of NMES in addition to aerobic exercise in IPF patients based on evidence by objective methods.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Thirty IPF patients aged 40-80 years who are followed up at Istanbul University, Istanbul Medical Faculty Chest Disease Department will include in the study. Participants will be divided into two groups as the NMES group and the Sham Training Group, using a computer-assisted randomization table.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The assessor will be blind to the randomization and the investigator will be blind to the results of assessments.
Primary Purpose: Treatment
Official Title: Investigation of the Effectiveness of Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis
Actual Study Start Date : March 20, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : April 1, 2020


Arm Intervention/treatment
Sham Comparator: Sham group
Following the assessments, sham group will participate in a 20-30 minute low-medium intensity aerobic exercise training with cycling ergometer. In Sham training group, NMES will be applied to the same region after aerobic exercise, current frequency is 5 Hz, current transit time is 300 μs, 10 seconds warning, 30 seconds electrical stimulation in 20 seconds rest period. The rehabilitation program will be administered two days a week for 8 weeks under the supervision of a physiotherapist.
Other: Aerobic exercise
A 20-30 minutes low-medium intensity aerobic exercise training with cycling ergometer.

Experimental: NMES group

Following the assessments, both groups will participate in a 20-30 minute low-medium intensity aerobic exercise training with cycling ergometer.

After the aerobic exercise in NMES group, bilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds.

Other: Aerobic exercise
A 20-30 minutes low-medium intensity aerobic exercise training with cycling ergometer.

Other: Neuromuscular electrical stimulation
Bilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds




Primary Outcome Measures :
  1. Assessment of exercise capacity [ Time Frame: 2 months ]
    Exercise capacity will be assessed with 6-minutes walk test. The six minutes walking distance will be recorded in "metres".

  2. Assessment of endurance capacity [ Time Frame: 2 months ]
    Endurance capacity will be assessed with "Shuttle Endurance Walking test". The number of shuttles will be recorded and maximum VO2 will be calculated.


Secondary Outcome Measures :
  1. Assessment of peripheral muscle strength [ Time Frame: 2 months ]
    Peripheral muscle strength will be assessed with hand held dynamometer for quadriceps muscles.

  2. Assessment of fatigue [ Time Frame: 2 months ]
    Fatigue will be assessed with Fatigue Severity Scale. The scale consists 9 questions. The minimum score is 0 and maximum score is 63. Higher scores indicate worse fatigue level.

  3. Assessment of activities of daily living [ Time Frame: 2 months ]
    The activities of daily living will be assessed by "The London Chest Daily Activities of Daily Living Questionnaire. The scale has 4 subgroups; self-care (4 question), about home (six question), physical activity (2 question) and leisure time (3 question). The minimum score is 0 and maximum score is 75. Higher scores indicate worse conditions.

  4. Assessment of quality of life: "Saint George Quality of Life Survey [ Time Frame: 2 months ]
    The quality of life will be assessed by "Saint George Quality of Life Survey". The scale consists 50 questions. The minimum score is 0 and the maksimum score is 100. Higher scores indicate poor quality of life.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of IPF according to current ATS / ERS guidelines has been followed by a pulmonary specialist for at least 6 months
  • Patients who are clinically stable, have no flare or infection.

Exclusion Criteria:

  • Orthopedic and neurological problems that may interfere with exercise training,
  • Modification of medical treatment during the study,
  • Unstable cardiac diseases,
  • Participation in another pulmonary rehabilitation program over the past 12 months,
  • Inadequate cooperation,
  • Contraindications for the application of neuromuscular electrical stimulation (risk of embolism, neoplasm, infection in the region of application, pacemaker, sensory defect).

Information from the National Library of Medicine

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): NCT03890250


Contacts
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Contact: Buket Akıncı, Assist.Prof +90 5056415692 barbuket@hotmail.com

Locations
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Turkey
Istanbul University Recruiting
Istanbul, Turkey
Contact: Buket Akıncı, Assist.Prof    + 90 5056415692    barbuket@hotmail.com   
Contact: Goksen Kuran Aslan, Assoc.Prof    + 90 5324095246    goksenkuran@hotmail.com   
Sub-Investigator: Ozge Ertan, PT         
Principal Investigator: Goksen Kuran Aslan, Assoc.Prof         
Sub-Investigator: Nigar Gulfer Okumus, Prof.Dr.         
Sponsors and Collaborators
Biruni University
Istanbul University-Cerrahpasa
Istanbul University
Investigators
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Principal Investigator: Buket Akıncı, Assist.Prof. Biruni University

Publications of Results:
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Responsible Party: Buket AKINCI, Assistant Proffesor, Biruni University
ClinicalTrials.gov Identifier: NCT03890250     History of Changes
Other Study ID Numbers: 2018/12-1
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Buket AKINCI, Biruni University:
pulmonary rehabilitation
neuromuscular electrical stimulation
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial