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

January 5, 2021 updated by: Royal Brompton & Harefield NHS Foundation Trust

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.

.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Middlesex
      • Harefield, Middlesex, United Kingdom, UB9 6JH
        • Royal Brompton and Harefield NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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
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.
Device: Active NMES
Neuromuscular electrical stimulation to the quadriceps muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walk test
Time Frame: Six weeks
Exercise capacity
Six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps maximum voluntary contraction
Time Frame: Six weeks and twelve weeks
Muscle strength
Six weeks and twelve weeks
Rectus-femoris cross-sectional area
Time Frame: Six weeks and twelve weeks
Muscle size
Six weeks and twelve weeks
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 weeks and twelve weeks
Six minute walk test
Time Frame: Twelve weeks
Exercise capacity
Twelve weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Collaborators

Kings Clinical Trials Unit

Investigators

  • Principal Investigator: William DC Man, PhD, Royal Brompton and Harefield NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2018

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ACTUAL)

August 15, 2020

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (ACTUAL)

April 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 241055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Pulmonary Fibrosis

Clinical Trials on Sham NMES

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe