Condition category
Respiratory
Date applied
31/05/2012
Date assigned
31/05/2012
Last edited
01/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
People with chronic obstructive pulmonary disease (COPD) often experience a reduced ability to exercise, which affects their independence and quality of life. Several factors contribute to this including leg muscle weakness. Exercise can help but even simple forms, e.g. walking, can be difficult when out of breath. An alternative is neuromuscular electrical stimulation (NMES) which uses a small battery-operated stimulator and pads placed over each thigh to produce a comfortable contraction and relaxation of the underlying muscles. Several small studies have found 4−6 week programmes to benefit patients but larger studies are required to confirm these findings.

Who can participate?
People diagnosed with COPD, attending clinics at the Kings College Hospital NHS Foundation Trust may be invited to take part by their usual clinical team.

What does the study involve?
In this study 52 people with severe COPD will be allocated to receive either active or ‘sham’ (dummy) NMES to the thigh muscles. Both programmes will consist of 30 minutes of daily stimulation for 6 weeks, but the level will be set to either allow muscle contraction (active) or provide sensation only (dummy). Before and after the programme participants’ ability to exercise, thigh muscle strength and size, physical activity level and quality of life will be assessed.

What are the possible benefits and risks of participating?
We hope that using NMES will help keep participants leg muscles strong and the information we get from this study should help us provide better care for people with COPD and will help confirm if NMES can benefit people with COPD unable to complete traditional forms of exercise. If successful, this may help this group maintain their independence for longer. It is however possible some participants will not gain any benefits from using NMES. NMES has been used in a wide range of medical conditions and there should be no serious side effects. People sometimes feel slight muscle soreness after first using NMES because it is a form of exercise, but this generally settles after a day or two.

Where is the study run from?
The study will run from Kings College Hospital NHS Foundation Trust.

When is study starting and how long is it expected to run for?
The study start in June 2012 and run approximately two years.

Who is funding the study?
National Institute for Health Research (NIHR)

Who is the main contact?
Dr Matthew Maddocks
matthew.maddocks@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthew Maddocks

ORCID ID

Contact details

Cicely Saunders Institute
Bessemer Road
Denmark Hill
London
SE5 9PJ
United Kingdom
+44 207 848 5242
matthew.maddocks@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12017

Study information

Scientific title

A randomised placebo-controlled trial investigating the effect of bilateral quadriceps NeuroMuscular Electrical Stimulation (NMES) on exercise capacity in patients with severe chronic obstructive pulmonary disease

Acronym

NMES

Study hypothesis

People with chronic obstructive pulmonary disease (COPD) often experience a reduced ability to exercise, which affects their independence and quality of life. Several factors contribute to this including leg muscle weakness.

Exercise can help but even simple forms, e.g. walking, can be difficult when out of breath. An alternative is neuromuscular electrical stimulation (NMES) which uses a small battery-operated stimulator and pads placed over each thigh to produce a comfortable contraction and relaxation of the underlying muscles. Several small studies have found 4-6 week programmes to benefit patients but larger studies are required to confirm these findings.

Fifty-two people with severe COPD will be allocated to receive either active or ‘sham’ NMES to the thigh muscles. Both programmes will consist of 30 minutes of daily stimulation for 6 weeks, but the level will be set to either allow muscle contraction (active) or provide sensation only (placebo). Before and after the programme participants’ ability to exercise, thigh muscle strength and size, physical activity level and quality of life will be assessed. Findings will confirm if NMES can benefit people with COPD unable to complete traditional forms of exercise. If successful, this may help this group maintain their independence for longer.

Ethics approval

London –Camberwell St Giles NRES Committee, ref:12/LO/0263

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease

Intervention

Active, NMES to the quadriceps for 30min daily for 6 weeks (frequency 50Hz, pulse width 350µs, duty cycle 11-50%, amplitude 0-120mA over 1000O). The proportion of the treatment duration which is active, i.e. the stimulation phase of the duty cycle, will increase on a weekly basis from 11% to 25% to 50%, remaining constant thereafter.

Control, Placebo NMES to the quadriceps for 30min daily for 6 weeks using levels of stimulation detectable by the patient but not able to elicit a tetanic muscle contraction (frequency 50Hz, pulse width 350µs, duty cycle 11-50%, amplitude 0-20mA).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Six-minute walk test (6MWT) at baseline, 6 and 12 weeks

Secondary outcome measures

1. Quadriceps function and size; assessed by quadriceps maximum voluntary contraction and twitch with femoral nerve stimulation, time for twitch to decline to 70% of maximum with repetitive transcutaneous stimulation, rectus femoris cross sectional area with ultrasonography and fat free mass by bioimpedence (kg).
2. Exercise capacity: assessed by 6MWT distance (m) at 12 weeks
3. Physical activity level: mean daily step count, up/down transitions and time spent upright
4. Health-related quality of life; overall health on EQ5D visual analogue scale (0−100), St Georges
5. Respiratory Questionnaire and Chronic Respiratoary Disease Questionnaire
6. Service utilisation; formal and informal care 12 weeks assessed by Client Service Reciept Inventory
7. Patients' experiences: semi-structured interviews in a sub-group of patients at 6 weeks

Overall trial start date

17/05/2012

Overall trial end date

17/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. >=18 years of age
2. Diagnosis of COPD [ forced expiratory volume in the first one second to the forced vital capacity of the lungs (FEV1: FVC ratio <=70%)]
3. Severe respiratory impairment (GOLD stage III/IV; FEV1 <=50% predicted)
4. Incapacitating breathlessness (MRC dyspnoea score 4/5)
5. Able to provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 52; UK Sample Size: 52

Participant exclusion criteria

1. Cardiac pacemaker
2. Co-existing neurological condition
3. Change in medication or exacerbation requiring admission in preceding 4 weeks
4. Recent systemic corticosteroids (>=5 consecutive days in last 4 weeks)
5. Current regular exerciser (structured training >=3 times/week within last month)
6. Adults unable to consent for themselves

Recruitment start date

17/05/2012

Recruitment end date

17/05/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cicely Saunders Institute
London
SE5 9PJ
United Kingdom

Sponsor information

Organisation

King College Hospital (UK)

Sponsor details

Child Health
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Doctoral Research Fellowship

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/26701362

Publication citations

Additional files

Editorial Notes

01/12/2016: Publication reference added.