Condition category
Musculoskeletal Diseases
Date applied
25/05/2009
Date assigned
09/07/2009
Last edited
18/03/2013
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

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

http://www.cappagh.ie/

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 (KNEEHABĀ®) 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

  1. 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.

Additional files

Editorial Notes