Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

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

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.

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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.

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.