Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Investigation of the Effectiveness of Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890250
• Other study ID #: 2018/12-1
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Neuromuscular Electrical Stimulation
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (3)

Lead Sponsor	Collaborator
Biruni University	Istanbul University, Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Holland AE, Wadell K, Spruit MA. How to adapt the pulmonary rehabilitation programme to patients with chronic respiratory disease other than COPD. Eur Respir Rev. 2013 Dec;22(130):577-86. doi: 10.1183/09059180.00005613. — View Citation

Jones S, Man WD, Gao W, Higginson IJ, Wilcock A, Maddocks M. Neuromuscular electrical stimulation for muscle weakness in adults with advanced disease. Cochrane Database Syst Rev. 2016 Oct 17;10(10):CD009419. doi: 10.1002/14651858.CD009419.pub3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of exercise capacity	Exercise capacity will be assessed with 6-minutes walk test. The six minutes walking distance will be recorded in "metres".	2 months
Primary	Assessment of endurance capacity	Endurance capacity will be assessed with "Shuttle Endurance Walking test". The number of shuttles will be recorded and maximum VO2 will be calculated.	2 months
Secondary	Assessment of peripheral muscle strength	Peripheral muscle strength will be assessed with hand held dynamometer for quadriceps muscles.	2 months
Secondary	Assessment of fatigue	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.	2 months
Secondary	Assessment of activities of daily living	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.	2 months
Secondary	Assessment of quality of life: "Saint George Quality of Life Survey	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.	2 months