Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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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. .

Detailed Description
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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.

Official Title
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MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Device: Active NMES
* Device: Sham NMES
* Other: Home exercise programme
* Other: Breathlessness advice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a study that comprises: A parallel group, randomised placebo-controlled, assessor-blinded trial with participants randomised (1:1) to usual care (home based exercise programme) with either placebo or active NMES for six weeks, with a 12 week follow-up. Qualitative interviews with participants and staff.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham NMES<br>Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management | Device: Sham NMES<br>* Sham neuromuscular electrical stimulation to the quadriceps muscle<br>Other: Home exercise programme<br>* Home exercise programme. Both arms of the trial receive this intervention.<br>Other: Breathlessness advice<br>* Breathlessness advice. Both arms of the trial receive this intervention.<br>|
| Experimental: Active NMES<br>Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management | Device: Active NMES<br>* Neuromuscular electrical stimulation to the quadriceps muscle<br>Other: Home exercise programme<br>* Home exercise programme. Both arms of the trial receive this intervention.<br>Other: Breathlessness advice<br>* Breathlessness advice. Both arms of the trial receive this intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk test | Exercise capacity | Six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps maximum voluntary contraction | Muscle strength | Six weeks and twelve weeks | 
| Rectus-femoris cross-sectional area | Muscle size | 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. | Six weeks and twelve weeks | 
| Six minute walk test | Exercise capacity | Twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromuscular electrical stimulation