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| Name | Class |
|---|---|
| Kings Clinical Trials Unit | UNKNOWN |
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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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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham NMES | Sham Comparator | Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management |
|
| Active NMES | Experimental | Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active NMES | Device | Neuromuscular electrical stimulation to the quadriceps muscle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk test | Exercise capacity | Six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps maximum voluntary contraction | Muscle strength | Six weeks and twelve weeks |
| Rectus-femoris cross-sectional area | Muscle size |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William DC Man, PhD | Royal Brompton and Harefield NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brompton and Harefield NHS Foundation Trust | Harefield | Middlesex | UB9 6JH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34083348 | Derived | 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. |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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This is a study that comprises:
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| Sham NMES |
| Device |
Sham neuromuscular electrical stimulation to the quadriceps muscle |
|
| Home exercise programme | Other | Home exercise programme. Both arms of the trial receive this intervention. |
|
| Breathlessness advice | Other | Breathlessness advice. Both arms of the trial receive this intervention. |
|
| Six weeks and twelve weeks |
| King's Brief Interstitial Lung Disease questionnaire | 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 weeks and twelve weeks |
| Six minute walk test | Exercise capacity | Twelve weeks |