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Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis (MUST-IPF)

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ClinicalTrials.gov Identifier: NCT03499275
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Collaborator:
Kings Clinical Trials Unit
Information provided by (Responsible Party):
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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Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Device: Active NMES Device: Sham NMES Other: Home exercise programme Other: Breathlessness advice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020


Arm Intervention/treatment
Sham Comparator: Sham NMES
Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Device: Sham NMES
Sham neuromuscular electrical stimulation to the quadriceps muscle

Other: Home exercise programme
Home exercise programme. Both arms of the trial receive this intervention.

Other: Breathlessness advice
Breathlessness advice. Both arms of the trial receive this intervention.

Experimental: Active NMES
Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Device: Active NMES
Neuromuscular electrical stimulation to the quadriceps muscle

Other: Home exercise programme
Home exercise programme. Both arms of the trial receive this intervention.

Other: Breathlessness advice
Breathlessness advice. Both arms of the trial receive this intervention.




Primary Outcome Measures :
  1. Six minute walk test [ Time Frame: Six weeks ]
    Exercise capacity


Secondary Outcome Measures :
  1. Quadriceps maximum voluntary contraction [ Time Frame: Six weeks and twelve weeks ]
    Muscle strength

  2. Rectus-femoris cross-sectional area [ Time Frame: Six weeks and twelve weeks ]
    Muscle size

  3. King's Brief Interstitial Lung Disease questionnaire [ 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.

  4. Six minute walk test [ Time Frame: Twelve weeks ]
    Exercise capacity



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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of IPF according to international standards.
  • Severe respiratory disability / breathlessness (Medical Research Council dyspnoea score ≥4).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499275


Contacts
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Contact: Claire M Nolan, MSc 00441895 828851 c.nolan@rbht.nhs.uk
Contact: Suhani Patel, MSc 00441895828851 s.patel122619@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton and Harefield NHS Foundation Trust Recruiting
Harefield, Middlesex, United Kingdom, UB9 6JH
Contact: Claire M Nolan, MSc    04418958288851 ext 8851    c.nolan@rbht.nhs.uk   
Contact: William DC Man, MD, PhD    01895828851 ext 8851    w.man@rbht.nhs.uk   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Kings Clinical Trials Unit
Investigators
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Principal Investigator: William DC Man, PhD Royal Brompton and Harefield NHS Foundation Trust

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03499275     History of Changes
Other Study ID Numbers: 241055
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Neuromuscular electrical stimulation
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial