Idiopathic Pulmonary FibrosisMUST-IPFNCT03499275
Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis
A study testing Active NMES, Home exercise programme and Breathlessness advice in people with Idiopathic Pulmonary Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. . Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Active NMES, Home exercise programme and Breathlessness advice
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2018to 15 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton and Harefield NHS Foundation Trust
Harefield, Middlesex, UB9 6JH
About this study
Official title: MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
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.
.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Active NMES, Sham NMES, Home exercise programme, Breathlessness advice
- Keywords
- Neuromuscular electrical stimulation
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active NMESDevice
Neuromuscular electrical stimulation to the quadriceps muscle
Sham NMESDevice
Sham neuromuscular electrical stimulation to the quadriceps muscle
Home exercise programmeOther
Home exercise programme. Both arms of the trial receive this intervention.
Breathlessness adviceOther
Breathlessness advice. Both arms of the trial receive this intervention.
| Study group | Role | What they receive |
|---|---|---|
| Sham NMES | Sham comparator | Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Receives: Device: Sham NMES; Other: Home exercise programme; Other: Breathlessness advice |
| Active NMES | Experimental | Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management Receives: Device: Active NMES; Other: Home exercise programme; Other: Breathlessness advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
Exercise capacity
Measured: Six weeks
Secondary outcomes (4)
Quadriceps maximum voluntary contraction
Muscle strength
Measured: Six weeks and twelve weeks
Rectus-femoris cross-sectional area
Muscle size
Measured: 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.
Measured: Six weeks and twelve weeks
Six minute walk test
Exercise capacity
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start15 Oct 2018
- Primary completion31 Mar 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Kings Clinical Trials Unit
- Responsible party
- Sponsor
- Investigators
- William DC Man, PhD, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499275
- Sponsor's protocol ID
- 241055
- Acronym
- MUST-IPF
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2018
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34083348
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03499275
- Acronym / sponsor ID
- MUST-IPF / 241055
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Kings Clinical Trials Unit
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sham NMES | Sham comparator | Device: Sham NMES, Other: Home exercise programme, Other: Breathlessness adviceSham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management |
| Active NMES | Experimental | Device: Active NMES, Other: Home exercise programme, Other: Breathlessness adviceNeuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active NMESNeuromuscular electrical stimulation to the quadriceps muscle | Device | Active NMES |
| Sham NMESSham neuromuscular electrical stimulation to the quadriceps muscle | Device | Sham NMES |
| Home exercise programmeHome exercise programme. Both arms of the trial receive this intervention. | Other | Active NMES, Sham NMES |
| Breathlessness adviceBreathlessness advice. Both arms of the trial receive this intervention. | Other | Active NMES, Sham NMES |
Primary outcome
Six minute walk test
Time frame: Six weeks
Exercise capacity
4 secondary outcomes
Quadriceps maximum voluntary contraction
Time frame: Six weeks and twelve weeks
Rectus-femoris cross-sectional area
Time frame: Six weeks and twelve weeks
King's Brief Interstitial Lung Disease questionnaire
Time frame: Six weeks and twelve weeks
Six minute walk test
Time frame: Twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Derived from this study: PubMed 34083348Nolan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William DC Man, PhD principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active NMES, Home exercise programme and Breathlessness advice in people with Idiopathic Pulmonary Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (time frame: Six weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.