Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

Royal Brompton & Harefield NHS Foundation Trust23 enrolled

Overview

The aims of this study are to determine whether neuromuscular stimulation (NMES) of the quadriceps muscle is acceptable to patients with Idiopathic Pulmonary Fibrosis (IPF) and staff and whether it can impact clinical and healthcare resource usage outcomes. .

Patients with IPF who consent to participate in the study will be allocated by chance to use 'active' or 'sham/placebo' NMES for six weeks. Patients will also complete a home exercise programme and receive advice on how to manage breathlessness. Clinical outcomes and trial flow after this six week programme and six weeks after patients have stopped using NMES will be assessed. After this point, healthcare resource use during the study period will be evaluated and interviews involving participants, their carers, and staff about their experiences of the study and using or delivering NMES will be conducted.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Active NMESDEVICE

Neuromuscular electrical stimulation to the quadriceps muscle

Sham NMESDEVICE

Sham neuromuscular electrical stimulation to the quadriceps muscle

Home exercise programmeOTHER

Home exercise programme. Both arms of the trial receive this intervention.

Eligibility

Sex: ALLMin age: 19 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of IPF according to international standards. * Severe respiratory disability / breathlessness (Medical Research Council dyspnoea score ≥3). * Able to provide written informed consent. * Declined or failed to complete a supervised centre-based pulmonary rehabilitation (PR) programme * Quadriceps maximum voluntary contraction \<80% predicted. Exclusion Criteria: * Cardiac pacemaker. * Co-existing neurological condition. * Change in medication or exacerbation requiring admission in preceding four weeks. * Current regular exerciser (structured supervised training ≥3 times per week within last month). * People who have completed PR in the previous six months.

Locations (1)

Royal Brompton and Harefield NHS Foundation Trust

Harefield, Middlesex, United Kingdom

Outcomes

Primary Outcomes

Six minute walk test

Exercise capacity

Time frame: Six weeks

Secondary Outcomes

Quadriceps maximum voluntary contraction

Muscle strength

Time frame: Six weeks and twelve weeks

Rectus-femoris cross-sectional area

Muscle size

Time frame: Six weeks and twelve weeks

King's Brief Interstitial Lung Disease questionnaire

Measure of health-related quality of life that includes three domains (psychological, breathlessness and activities, chest symptoms) and a total score. The score range for each domain and the total score ranges from 0 to 100 with higher scores indicating better health-related quality of life.

Time frame: Six weeks and twelve weeks

Six minute walk test

Exercise capacity

Time frame: Twelve weeks

Data from ClinicalTrials.gov

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