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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Active NMES
Sham NMES
Home exercise programme
Breathlessness advice
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Neuromuscular electrical stimulation

Eligibility Criteria

19 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Royal Brompton and Harefield NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham NMES

Active NMES

Arm Description

Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management

Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management

Outcomes

Primary Outcome Measures

Six minute walk test
Exercise capacity

Secondary Outcome Measures

Quadriceps maximum voluntary contraction
Muscle strength
Rectus-femoris cross-sectional area
Muscle size
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.
Six minute walk test
Exercise capacity

Full Information

First Posted
April 11, 2018
Last Updated
January 5, 2021
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Kings Clinical Trials Unit
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1. Study Identification

Unique Protocol Identification Number
NCT03499275
Brief Title
Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis
Acronym
MUST-IPF
Official Title
MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Collaborators
Kings Clinical Trials Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Neuromuscular electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham NMES
Arm Type
Sham Comparator
Arm Description
Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Arm Title
Active NMES
Arm Type
Experimental
Arm Description
Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management
Intervention Type
Device
Intervention Name(s)
Active NMES
Intervention Description
Neuromuscular electrical stimulation to the quadriceps muscle
Intervention Type
Device
Intervention Name(s)
Sham NMES
Intervention Description
Sham neuromuscular electrical stimulation to the quadriceps muscle
Intervention Type
Other
Intervention Name(s)
Home exercise programme
Intervention Description
Home exercise programme. Both arms of the trial receive this intervention.
Intervention Type
Other
Intervention Name(s)
Breathlessness advice
Intervention Description
Breathlessness advice. Both arms of the trial receive this intervention.
Primary Outcome Measure Information:
Title
Six minute walk test
Description
Exercise capacity
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Quadriceps maximum voluntary contraction
Description
Muscle strength
Time Frame
Six weeks and twelve weeks
Title
Rectus-femoris cross-sectional area
Description
Muscle size
Time Frame
Six weeks and twelve weeks
Title
King's Brief Interstitial Lung Disease questionnaire
Description
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.
Time Frame
Six weeks and twelve weeks
Title
Six minute walk test
Description
Exercise capacity
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William DC Man, PhD
Organizational Affiliation
Royal Brompton and Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton and Harefield NHS Foundation Trust
City
Harefield
State/Province
Middlesex
ZIP/Postal Code
UB9 6JH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34083348
Citation
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.
Results Reference
derived

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Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

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