Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

NCT ID: NCT03890250

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2024-01-01

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.

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.

Conditions

Idiopathic Pulmonary Fibrosis; Neuromuscular Electrical Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: SHAM_COMPARATOR

Aerobic exercise

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: OTHER

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

Neuromuscular electrical stimulation

Intervention Type: OTHER

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

Interventions

Aerobic exercise

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Istanbul University

OTHER

Sponsor Role: collaborator

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Buket AKINCI

Assistant Proffesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buket Akıncı, Assist.Prof.

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Locations

Istanbul University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 24293474 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27748503 (View on PubMed)

Other Identifiers

2018/12-1

Identifier Type: -

Identifier Source: org_study_id