Idiopathic Pulmonary Fibrosis
Conditions
Keywords
Neuromuscular electrical stimulation
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.
Interventions
DEVICEActive NMES
Neuromuscular electrical stimulation to the quadriceps muscle
DEVICESham NMES
Sham neuromuscular electrical stimulation to the quadriceps muscle
Home exercise programme. Both arms of the trial receive this intervention.
OTHERBreathlessness advice
Breathlessness advice. Both arms of the trial receive this intervention.
Sponsors
Kings Clinical Trials Unit
Royal Brompton & Harefield NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test | Six weeks | Exercise capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps maximum voluntary contraction | Six weeks and twelve weeks | Muscle strength |
| Rectus-femoris cross-sectional area | Six weeks and twelve weeks | Muscle size |
| 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. |
| Six minute walk test | Twelve weeks | Exercise capacity |
Countries
United Kingdom
Outcome results
None listed