Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Device: Active NMESDevice: Sham NMESOther: Home exercise programmeOther: Breathlessness advice
- Registration Number
- NCT03499275
- Lead Sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham NMES Breathlessness advice Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Active NMES Active NMES Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Active NMES Breathlessness advice Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Sham NMES Home exercise programme Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Active NMES Home exercise programme Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Sham NMES Sham NMES Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
- Primary Outcome Measures
Name Time Method Six minute walk test Six weeks Exercise capacity
- Secondary Outcome Measures
Name Time Method Quadriceps maximum voluntary contraction Six weeks and twelve weeks Muscle strength
King's Brief Interstitial Lung Disease questionnaire Six weeks and twelve weeks 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.
Rectus-femoris cross-sectional area Six weeks and twelve weeks Muscle size
Six minute walk test Twelve weeks Exercise capacity
Trial Locations
- Locations (1)
Royal Brompton and Harefield NHS Foundation Trust
🇬🇧Harefield, Middlesex, United Kingdom