Clinical trial NCT03499275: Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis
Official title: MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Neuromuscular electrical stimulation
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Kings Clinical Trials Unit
First posted: 2018-04-17
Enrollment: 23
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Six minute walk test
timeFrame: Six weeks
Secondary outcomes:
measure: Quadriceps maximum voluntary contraction
timeFrame: Six weeks and twelve weeks
measure: Rectus-femoris cross-sectional area
timeFrame: Six weeks and twelve weeks
measure: King's Brief Interstitial Lung Disease questionnaire
timeFrame: Six weeks and twelve weeks
measure: Six minute walk test
timeFrame: Twelve weeks
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
state: Middlesex
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: William DC Man, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nolan CM, Patel S, Barker RE, Walsh JA, Polgar O, Maddocks M, George PM, Renzoni EA, Wells AU, Molyneaux PL, Kouranos V, Chua F, Maher TM, Man WD. Muscle stimulation in advanced idiopathic pulmonary fibrosis: a randomised placebo-controlled feasibility study. BMJ Open. 2021 Jun 2;11(6):e048808. doi: 10.1136/bmjopen-2021-048808.