Strengthening hip muscles to improve walking distance in people with Charcot-Marie-Tooth disease

ISRCTN	ISRCTN87551289
DOI	https://doi.org/10.1186/ISRCTN87551289
Secondary identifying numbers	12

Submission date: 08/04/2009
Registration date: 12/05/2009
Last edited: 23/05/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mary Reilly
Scientific

MRC Centre for Neuromuscular Diseases
National Hospital for Neurology and Neurosurgery
Queen Square
London
WC1N 3BG
United Kingdom

Phone	+44 (0)20 7837 3611 ext. 3457
Email	m.reilly@ion.ucl.ac.uk

Study information

Study design	Randomised single-blinded crossover trial
Primary study design	Interventional
Secondary study design	Randomised cross over 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	Strengthening hip muscles to improve walking distance in people with Charcot-Marie-Tooth disease: a randomised single-blinded crossover trial
Study objectives	To ascertain whether training the hip flexor muscles allows them to increase in strength. The study then aims to explore whether these strength changes allow the hip flexor muscles to be utilised for longer when walking and thus improve walking endurance.
Ethics approval(s)	Barnet, Enfield and Haringey Local Research Ethics Committee, 27/02/2009, ref: 09/H0723/6
Health condition(s) or problem(s) studied	Charcot-Marie-Tooth disease
Intervention	There will be two 16-week periods with an 8-week washout phase post-exercise intervention. Subjects will be assigned to two groups and will either continue their normal activities or will target the hip flexors muscles. Measures of strength and functional ability will be recorded at the start and finish of each 16-week period. Thirty two subjects will be randomly allocated to the two groups. A blinded assessor will record the outcome measures.
Intervention type	Behavioural
Primary outcome measure	Isometric muscle strength of the hip flexors - measured using fixed myometry. Timepoints: Group A: Baseline (0 weeks), post-intervention (16 weeks), post-washout (24 weeks), final measurement (40 weeks) Group B: Baseline (0 weeks), post-control (16 weeks), post-intervention (32 weeks), post-washout (40 weeks)
Secondary outcome measures	1. Six Minute Timed Walk Test: change in maximal walking distance in 6 minutes and peak heart rate 2. Walking speed: using a Timed 10 Metre Walk Test 3. Perceived exertion during the Six Minute Timed Walk Test: using the Borg 15-point scale 4. Heart rate and Physiological Cost Index (PCI) during the Six Minute Timed Walk Test: using a heart rate monitor 5. Fatigue: assessed using the Fatigue Severity Scale (FSS) 6. Perception of walking ability: Walk-12 scale 7. Disease severity: Charcot-Marie-Tooth Symptom/Sign Score (CMTSS) 8. Physical limitations: Overall Neuropathy Limitations Scale (ONLS) 9. Pain: assessed using the Visual Analogue Scale (VAS) Timepoints: Group A: Baseline (0 weeks), post-intervention (16 weeks), post-washout (24 weeks), final measurement (40 weeks) Group B: Baseline (0 weeks), post-control (16 weeks), post-intervention (32 weeks), post- washout (40 weeks)
Overall study start date	01/04/2009
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	32
Key inclusion criteria	People will be recruited provided all of the following criteria are satisfied: 1. Clinical diagnosis of Charcot-Marie-Tooth disease (CMT) 2. Aged 18 to 70 years, either sex 3. Able to walk for 50 m with or without a walking aid or orthotic devices 4. Signed informed participant consent
Key exclusion criteria	People will be excluded from the study if one or more of the following criteria apply: 1. Presence of other significant neurological disorders (such as multiple sclerosis, cerebrovascular diseases, movement disorders), or major comorbidities (e.g., definite cognitive impairment, psychiatric disease, heart or lung failure, orthopaedic or rheumatological disorders) 2. Limb surgery during the six months prior to screening (or planned before final assessment) 3. Severe congenital hip dysplasia associated with CMT 4. Aged over 70 or under 18 years 5. Women of child-bearing age only if they are pregnant at the inclusion into the study or plan to become pregnant during the study (people agreeing not to become pregnant during the study must take appropriate contraceptive methods - contraceptive pill, intrauterine device, barrier methods)
Date of first enrolment	01/04/2009
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

National Hospital for Neurology and Neurosurgery

London
WC1N 3BG
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Joint UCLH & UCL Biomedical Research Unit (R&D)
Rosenheim Wing
Ground Floor
25 Grafton Way
London
WC1E 5DB
England
United Kingdom

Email	philip.diamond@uclh.nhs.uk
Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Charity

Muscular Dystrophy Campaign (MDC) (UK)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014		Yes	No

Editorial Notes

23/05/2016: Publication reference added.