Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

NCT03890250 | Completed

• 1 other identifier: 2018/12-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis; Neuromuscular Electrical Stimulation

Keywords

pulmonary rehabilitation; neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Assessment of peripheral muscle strength

  2 months

• Assessment of fatigue

  2 months

• Assessment of activities of daily living

  2 months

• Assessment of quality of life: "Saint George Quality of Life Survey

  2 months

Study Arms (2)

Sham group

SHAM COMPARATOR

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

NMES group

EXPERIMENTAL

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; Other: Neuromuscular electrical stimulation

Interventions

Aerobic exercise OTHER

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

NMES group; Sham group

Neuromuscular electrical stimulation 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

NMES group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Biruni University: lead
• Istanbul University - Cerrahpasa: collaborator
• Istanbul University: collaborator

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

Related 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.

  PMID: 24293474 RESULT

• 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.

  PMID: 27748503 RESULT

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Buket Akıncı, Assist.Prof.

  Biruni University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The assessor will be blind to the randomization and the investigator will be blind to the results of assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 26, 2019
• Study Start: March 20, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)