NCT03499275

Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Royal Brompton & Harefield NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DEVICE	Active NMES	Neuromuscular electrical stimulation to the quadriceps muscle
DEVICE	Sham NMES	Sham neuromuscular electrical stimulation to the quadriceps muscle
OTHER	Home exercise programme	Home exercise programme. Both arms of the trial receive this intervention.
OTHER	Breathlessness advice	Breathlessness advice. Both arms of the trial receive this intervention.

Timeline

• Start date: 2018-10-15
• Primary completion: 2020-03-31
• Completion: 2020-08-15
• First posted: 2018-04-17
• Last updated: 2021-01-07

Locations

1 site across 1 country: United Kingdom