NCT03499275

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. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

April 11, 2018

Last Update Submit

January 5, 2021

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Six minute walk test

    Exercise capacity

    Six weeks

Secondary Outcomes (4)

  • Quadriceps maximum voluntary contraction

    Six weeks and twelve weeks

  • Rectus-femoris cross-sectional area

    Six weeks and twelve weeks

  • King's Brief Interstitial Lung Disease questionnaire

    Six weeks and twelve weeks

  • Six minute walk test

    Twelve weeks

Study Arms (2)

Sham NMES

SHAM COMPARATOR

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

Device: Sham NMESOther: Home exercise programmeOther: Breathlessness advice

Active NMES

EXPERIMENTAL

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

Device: Active NMESOther: Home exercise programmeOther: Breathlessness advice

Interventions

Active NMESDEVICE

Neuromuscular electrical stimulation to the quadriceps muscle

Active NMES
Sham NMESDEVICE

Sham neuromuscular electrical stimulation to the quadriceps muscle

Sham NMES
Home exercise programmeOTHER

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

Active NMESSham NMES
Breathlessness adviceOTHER

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

Active NMESSham NMES

Eligibility Criteria

Age19 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

Harefield, Middlesex, UB9 6JH, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34083348DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • William DC Man, PhD

    Royal Brompton and Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 17, 2018

Study Start

October 15, 2018

Primary Completion

March 31, 2020

Study Completion

August 15, 2020

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)