Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2020-08-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Idiopathic Pulmonary Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham NMES

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

Group Type SHAM_COMPARATOR

Sham NMES

Intervention Type DEVICE

Sham neuromuscular electrical stimulation to the quadriceps muscle

Home exercise programme

Intervention Type OTHER

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

Breathlessness advice

Intervention Type OTHER

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

Active NMES

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

Group Type EXPERIMENTAL

Active NMES

Intervention Type DEVICE

Neuromuscular electrical stimulation to the quadriceps muscle

Home exercise programme

Intervention Type OTHER

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

Breathlessness advice

Intervention Type OTHER

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

Interventions

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Active NMES

Neuromuscular electrical stimulation to the quadriceps muscle

Intervention Type DEVICE

Sham NMES

Sham neuromuscular electrical stimulation to the quadriceps muscle

Intervention Type DEVICE

Home exercise programme

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

Intervention Type OTHER

Breathlessness advice

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No