Condition category
Respiratory
Date applied
22/11/2010
Date assigned
03/05/2011
Last edited
28/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Greening

ORCID ID

Contact details

CLAHRC Rehabilitation Theme Office (Ward 25)
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+44 (0)116 250 2762
neil.greening@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol Version 1

Study information

Scientific title

The effects of unilateral neuromuscular stimulation on quadriceps muscle morphology, architecture and function in chronic obstructive pulmonary disease

Acronym

Study hypothesis

The overarching hypothesis of this proposal is that neuromuscular electrical stimulation (NMES) results in changes to quadriceps microstructure, architecture and function.

Ethics approval

West Midlands Research Ethics Committee approved on the 11th November 2010 (ref: 10/H1208/73)

Study design

Single centre parallel design randomised controlled trial

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

Respiratory disease (chronic obstructive pulmonary disease)

Intervention

1. Single leg resistance training (control):
Three supervised quadriceps resistance training sessions per week for 6 weeks.

2. Single leg neuromuscular elctrical stimulation (experimental):
Three supervised and two unsupervised sessions of neuromuscular electrical stimulation per week for 6 weeks.

Intervention duration: 6 weeks
Total follow up: 6 weeks (time of intervention)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Muscle Mass: quadriceps mass change at 6 weeks

Secondary outcome measures

1. Neural Adaptations to Training at 6 weeks
2. Muscle Architecture including pennation angle at 6 weeks
3. Muscle Morphology including fibre type at 6 weeks
4. Muscle hypertrophy including satellite cell activity and cross sectional area at 24 hours and 6 weeks
5. Acute local inflammation response at 24 hours and 6 weeks
6. Functional change in quadriceps strength at 6 weeks

Overall trial start date

01/01/2011

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of COPD
2. Forced expiratory volume in one second (FEV1) less than 50% predicted
3. FEV1/forced vital capacity (FVC) ratio less than 70%
4. Medical Research Council (MRC) dyspnoea score greater than 3
5. Clinically stable at time of recruitment (greater than 4 weeks exacerbation free)
6. Aged greater than 40 years, both sexes

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Uses long-term oral corticosteroids
2. Uses anticoagulation (e.g. warfarin)
3. Impaired clotting
4. Long-term oxygen therapy
5. Comorbid condition preventing exercise training, causing exercise limitation
6. Pulmonary rehabilitation in last 12 months
7. Condition causing intramuscular inflammation (e.g. type two diabetes [T2D], rheumatoid arthritis, inflammatory bowel disease)

Recruitment start date

01/01/2011

Recruitment end date

31/07/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

CLAHRC Rehabilitation Theme Office (Ward 25)
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Carolyn Maloney
Research & Development Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.uhl-tr.nhs.uk/ourservices/rd

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Collaboration for Leadership in Applied Health Research and Care (CLAHRC)

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

Publication citations

Additional files

Editorial Notes