Effects of neuromuscular stimulation on quadriceps in chronic obstructive pulmonary disease (COPD)

ISRCTN	ISRCTN87439020
DOI	https://doi.org/10.1186/ISRCTN87439020
Secondary identifying numbers	Protocol Version 1

Submission date: 22/11/2010
Registration date: 03/05/2011
Last edited: 02/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Neil Greening
Scientific

CLAHRC Rehabilitation Theme Office (Ward 25)
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom

Phone	+44 (0)116 250 2762
Email	neil.greening@uhl-tr.nhs.uk

Study information

Study design	Single centre parallel design randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effects of unilateral neuromuscular stimulation on quadriceps muscle morphology, architecture and function in chronic obstructive pulmonary disease
Study objectives	The overarching hypothesis of this proposal is that neuromuscular electrical stimulation (NMES) results in changes to quadriceps microstructure, architecture and function.
Ethics approval(s)	West Midlands Research Ethics Committee, 11/11/2010, ref: 10/H1208/73
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2011
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key 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
Key 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)
Date of first enrolment	01/01/2011
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

CLAHRC Rehabilitation Theme Office (Ward 25)

Leicester
LE3 9QP
United Kingdom

Sponsor information

University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre

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

Website	http://www.uhl-tr.nhs.uk/ourservices/rd
"ROR"	https://ror.org/02fha3693

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/02/2017: No publications found in PubMed, verifying study status with principal investigator.