Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499275
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
Kings Clinical Trials Unit
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

.


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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 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
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 ≥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.

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
Harefield, Middlesex, United Kingdom, UB9 6JH
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Kings Clinical Trials Unit
Investigators
Layout table for investigator information
Principal Investigator: William DC Man, PhD Royal Brompton and Harefield NHS Foundation Trust
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03499275    
Other Study ID Numbers: 241055
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases