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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

Tracking Information
First Submitted Date  ICMJE April 11, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date October 17, 2018
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Six minute walk test [ Time Frame: Six weeks ]
Exercise capacity
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03499275 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Quadriceps maximum voluntary contraction [ Time Frame: Six weeks and twelve weeks ]
    Muscle strength
  • Rectus-femoris cross-sectional area [ Time Frame: Six weeks and twelve weeks ]
    Muscle size
  • 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.
  • Six minute walk test [ Time Frame: Twelve weeks ]
    Exercise capacity
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • Quadriceps maximum voluntary contraction [ Time Frame: Six weeks and twelve weeks ]
    Muscle strength
  • Rectus-femoris cross-sectional area [ Time Frame: Six weeks and twelve weeks ]
    Muscle size
  • King's Brief Interstitial Lung Disease questionnaire [ Time Frame: Six weeks and twelve weeks ]
    Health-related quality of life
  • Six minute walk test [ Time Frame: Twelve weeks ]
    Exercise capacity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis
Official Title  ICMJE MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
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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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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Device: Active NMES
    Neuromuscular electrical stimulation to the quadriceps muscle
  • 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.
Study Arms  ICMJE
  • Sham Comparator: Sham NMES
    Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
    Interventions:
    • Device: Sham NMES
    • Other: Home exercise programme
    • Other: Breathlessness advice
  • Experimental: Active NMES
    Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
    Interventions:
    • Device: Active NMES
    • Other: Home exercise programme
    • Other: Breathlessness advice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claire M Nolan, MSc 00441895 828851 c.nolan@rbht.nhs.uk
Contact: Suhani Patel, MSc 00441895828851 s.patel122619@rbht.nhs.uk
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03499275
Other Study ID Numbers  ICMJE 241055
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor  ICMJE Royal Brompton & Harefield NHS Foundation Trust
Collaborators  ICMJE Kings Clinical Trials Unit
Investigators  ICMJE
Principal Investigator: William DC Man, PhD Royal Brompton and Harefield NHS Foundation Trust
PRS Account Royal Brompton & Harefield NHS Foundation Trust
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP