Royal Brompton and Harefield NHS Foundation Trust
Harefield, Middlesex, UB9 6JH, United Kingdom
NCT Number: NCT03499275
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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Notify Me19 year–100 year
All sexes
Interventional
Not applicable
Harefield, Middlesex, UB9 6JH, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Neuromuscular electrical stimulation to the quadriceps muscle
Sham neuromuscular electrical stimulation to the quadriceps muscle
Home exercise programme. Both arms of the trial receive this intervention.
Breathlessness advice. Both arms of the trial receive this intervention.
Time frame: Six weeks
Exercise capacity
Time frame: Six weeks and twelve weeks
Muscle strength
Time frame: Six weeks and twelve weeks
Muscle size
Time frame: 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.
Time frame: Twelve weeks
Exercise capacity
Royal Brompton & Harefield NHS Foundation Trust
Other
MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
Acronym: MUST-IPF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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