Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— MUST-IPF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499275
• Other study ID #: 241055
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: August 15, 2020

Study information

• Verified date: January 2021
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 15, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Device:
• Active NMES
Neuromuscular electrical stimulation to the quadriceps muscle
• 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.
• Breathlessness advice
Breathlessness advice. Both arms of the trial receive this intervention.

Locations

Country	Name	City	State
United Kingdom	Royal Brompton and Harefield NHS Foundation Trust	Harefield	Middlesex

Sponsors (2)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust	Kings Clinical Trials Unit

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six minute walk test	Exercise capacity	Six weeks
Secondary	Quadriceps maximum voluntary contraction	Muscle strength	Six weeks and twelve weeks
Secondary	Rectus-femoris cross-sectional area	Muscle size	Six weeks and twelve weeks
Secondary	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 weeks and twelve weeks
Secondary	Six minute walk test	Exercise capacity	Twelve weeks