MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Six minute walk test
Study Overview
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.
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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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sham NMES
Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention: Sham NMES (Device)
Sham NMES
Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention: Home exercise programme (Other)
Sham NMES
Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention: Breathlessness advice (Other)
Active NMES
Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention: Breathlessness advice (Other)
Active NMES
Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention: Active NMES (Device)
Active NMES
Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention: Home exercise programme (Other)
Outcomes
Primary Outcomes
Six minute walk test
Time Frame: Six weeks
Exercise capacity
Secondary Outcomes
- Quadriceps maximum voluntary contraction(Six weeks and twelve weeks)
- King's Brief Interstitial Lung Disease questionnaire(Six weeks and twelve weeks)
- Rectus-femoris cross-sectional area(Six weeks and twelve weeks)
- Six minute walk test(Twelve weeks)