Contact information
Type
Scientific
Primary contact
Mr Robert Bruce-Brand
ORCID ID
Contact details
69 Bridgewater Quay
Conyngham Road
Dublin
D8
Ireland
+353 (0)87 947 0721
robbrucebrand@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effects of resistance training and neuromuscular electrical stimulation (NMES) in advanced knee osteoarthritis - a comparison of the outcomes of a 6-week program of resistance training versus a 6-week program of NMES versus controls: a prospective, single blinded, randomised, interventional/treatment, efficacy study
Acronym
Study hypothesis
How do the two interventions compare objectively (in terms of isometric and isokinetic quadriceps strength, knee functional capacity and quadriceps hypertrophy) and subjectively (in terms of validated surveys of functional health and arthritis)? Do the two modalities induce different changes in gene expression in the muscle atrophy and hypertrophy pathways?
Ethics approval
Research Ethics Committee of Cappagh National Orthopaedic Hospital (affiliated with the Royal College of Surgeons in Ireland) provisionally approved on the 30th October 2008 (ref: RBB/10/2008/20). Full written approval granted by the same committee on the 30th March 2009.
Study design
Single centre interventional treatment single-blind randomised prospective efficacy study
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
Knee osteoarthritis
Intervention
Arm A:
A 6-week home-based exercise program, with particular emphasis on strengthening the quadriceps femoris muscle. The exercises will be adapted to account for individual symptoms and disability severity. Exercises will be performed 3 times per week, with a minimum of 36 hours between each session. Two of the weekly exercise sessions will be supervised by final year Health and Human Performance students of Dublin City University.
Arm B:
A 6-week program of home-based quadriceps femoris neuromuscular electrical stimulation. This will comprise 20 minute sessions 5 times a week, using a portable garment stimulator (Kneehab II, Neurotech, Galway, Ireland). Patients will receive specific instruction from a member of the study team on the application and logbook recording of the stimulator. The device will be applied to the subject's affected thigh, with electrode placement depending on thigh length and girth according to the manufacturer's guidelines. It will be ensured that each subject is competent with garment application, stimulator controls, and completion of the log-diary before commencing training.
Arm C (control group):
Controls will receive standard care. They will undergo all the same functional and clinical evaluations, quadriceps strength assessments, magnetic resonance imaging (MRI) scanning and self-report questionnaires at the same time points as the two intervention groups, but will not undergo muscle biopsies.
Subjects will be assessed at baseline, week 1 (end of familiarisation period), week 7 (end of training period) and week 13 (6 weeks post-training period). Patients in the intervention arms (A and B) will be followed up for 6 weeks post-intervention, and the controls (arm C) will be followed up for the equivalent period.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. 36-item Short Form Health Survey (SF-36) and Western Ontario McMaster University Arthritis index (WOMAC) scores, measured at baseline, week 7 and week 13
2. Isometric quadriceps strength (peak torque at 60 degrees of knee flexion) measured bilaterally with a dynamometer, assessed at baseline, week 1 (end of familiarisation period), week 7 (end of training period) and week 13 (6 weeks post-training period)
3. Isokinetic strength at 60 degrees per second in knee extension and flexion measured bilaterally with a dynamometer, assessed at baseline, week 1 (end of familiarisation period), week 7 (end of training period) and week 13 (6 weeks post-training period)
4. Functional testing including a timed 25-metre walking test, a timed stair climbing test and a timed up/down seated test, assessed at baseline, week 1 (end of familiarisation period), week 7 (end of training period) and week 13 (6 weeks post-training period)
5. Quadriceps femoris cross-sectional area on MRI imaging, taken at baseline and week 7
Secondary outcome measures
1. Knee flexion and extension limits, both active and passive
2. Height and weight measurements, to determine body mass index
3. Physical activity level
4. Knee pain score immediately before and during all functional and strength testing
5. Vastus lateralis muscle biopsy analysis, taken at baseline and at week 7. Analysis of the muscle biopsy tissue will take place after all participants have completed week 13.
5.1. Key functional and structural protein content including myosin heavy chain
5.2. Gene expression associated with muscle hypertrophy (insulin-like growth factor 1 [IGF-1]) and atrophy (MAFbx and MURF-1)
All secondary outcome measures except the muscle biopsies will be measured at baseline, week 1 (end of familiarisation period), week 7 (end of training period) and week 13 (6 weeks post-training period).
Overall trial start date
01/01/2009
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female patients aged 55 - 75 years
2. Advanced knee osteoarthritis (grade 3 or 4 knee osteoarthritis diagnosed arthroscopically within the last 2 years, or placed on the waiting list for knee replacement surgery with the indication of osteoarthritis within the last 12 months)
3. Ambulatory patients
4. Residing in the Greater Dublin area
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
35 - 40 patients
Participant exclusion criteria
1. Medical co-morbidities that preclude an exercise program
2. Neurological disorder
3. Implanted electrical device
4. Uncontrolled hypertension
5. Anticoagulant therapy
6. Malignancy
7. Inflammatory arthritis
8. Prior ipsilateral knee replacement surgery or contra-lateral knee replacement surgery within the last 2 years
9. Recent participation in an exercise or strength training program
10. Recent participation in a similar study
Recruitment start date
01/01/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Ireland
Trial participating centre
69 Bridgewater Quay
Dublin
D8
Ireland
Sponsor information
Organisation
Cappagh National Orthopaedic Hospital (Ireland)
Sponsor details
Finglas
Dublin
11
Ireland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Cappagh National Orthopaedic Hospital (Ireland) - facilities used to perform clinical assessments, percutaneous muscle biopsies and MRI scans
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dublin City University (Ireland) - laboratories and consumables used for the analysis of the muscle samples; dynamometer used for strength testing;
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bio-medical Research (Ireland) - providing neuromuscular stimulators (KNEEHAB®) at no cost. No financial benefit or agreement for same has been made.
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
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22759883
Publication citations
-
Results
Bruce-Brand RA, Walls RJ, Ong JC, Emerson BS, O'Byrne JM, Moyna NM, Effects of home-based resistance training and neuromuscular electrical stimulation in knee osteoarthritis: a randomized controlled trial., BMC Musculoskelet Disord, 2012, 13, 118, doi: 10.1186/1471-2474-13-118.