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OpenTrials
Completed

NCT Number: NCT03499275

Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

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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Key information

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton and Harefield NHS Foundation Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active NMES

Device

Neuromuscular electrical stimulation to the quadriceps muscle

Sham NMES

Device

Sham neuromuscular electrical stimulation to the quadriceps muscle

Home exercise programme

Other

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

Breathlessness advice

Other

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

Primary outcomes

  1. Six minute walk test

    Time frame: Six weeks

    Exercise capacity

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Collaborators

  • Kings Clinical Trials Unit

Registry information

Official study title

MUscle STimulation in Advanced Idiopathic Pulmonary Fibrosis: a Randomised Placebo-controlled Trial

Acronym: MUST-IPF

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2018
Registry last updated
Jan 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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