Is there a difference in clinical outcomes between aerobic exercises and strengthening programmes for people with knee osteoarthritis?

What is the optimal dosage (frequency/intensity) of exercise for those with knee osteoarthritis?

We will conduct a search of published and unpublished articles and conference proceedings published on or before 1st September 2012.

The electronic databases used to search the published literature will be: AMED, CINAHL, MEDLINE, EMBASE, PubMed and the Cochrane Library (Clinical trials database and database of systematic reviews). The unpublished literature and on-going trials will be searched using the databases: the WHO International Clinical Trials Registry Platform, Current Controlled Trials and the United States National Institute of Health Trials Registry, and Open Grey (System for Information on Grey Literature in Europe).

The reference lists of all pertinent review papers and all potentially eligible trials will be reviewed. Finally, all corresponding authors from all included trials will be contacted and requested to review the search results in order to identify any initially omitted publications or on-going trials.

Randomised, quasi-randomised and non-randomised controlled trials will be included in this review.

Osteoarthritis has been reported as one of the most common musculoskeletal disorders, affecting millions of people worldwide. It is characterised by pain, stiffness and decreased range of motion. This contributes to functional disability and loss of independence. This is especially the case in the elderly population. The knee is considered the most common form of osteoarthritis.

Participants will be people who have reported knee pain and symptoms attributed to osteoarthritis of the tibiofemoral and/or patellofemoral joint. No restriction will be placed on the duration or severity of knee symptoms or on the grade of radiological changes to the patellofemoral and/or tibiofemoral joint.

The interventions under investigation are different types and doses of exercises. These may include aerobic exercises such as walking, jogging, running, cycling, swimming, or strengthening exercises with or without devices such as weights, exercise band or resistance equipment. Such exercises may include isometric, isotonic or isokinetic exercises, performed as open- or closed-kinetic chains, or as eccentric or concentric. Exercises may also vary in relation to their frequency and intensity. These variables will be explored in this review.

The comparative arms are different types and doses of exercises as stated above.

Exercise interventions may be provided in a variety of different environments. These may therefore include: hospital and clinic settings, participants' homes and community groups and sports halls or gyms.

Primary outcomes

Pain level measured at 12 months using a visual analogue score (or equivalent).

The primary end-point for this outcome measure is 12 months.

Secondary outcomes

(1) Pain score using a visual analogue score (or equivalent) at other follow-up periods to 12 months

(2) Functional outcomes measured using tools such as the Westren Ontario and McMaster Universities index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS) or Oxford Knee Score.

(3) Patient satisfaction

(4) Anxiety and Depression scores

(5) Timed-Get-Up-and-Go

(6) 6-meter walk test

(7) Timed stair ascent

(8) Frequency of hospital/health care consultation

(9) Analgesic requirement

(10) General quality of life/health scores

No specific time-limit will be placed on these outcomes. However, the final follow-up period for each eligible study will be presented as a minimum.

The titles and abstracts from the results of the search strategy will be reviewed by two reviewers independently (TS, LD). Full-texts will be retrieved for all potentially suitable papers. These will be cross-checked to the eligibility criteria to identify all included trials in this study.

All data will be extracted by one reviewer (EK) onto a pre-defined data extraction table. All data will be subsequently verified by a second reviewer (TS).

Methodological assessment of each included study will be conducted by one reviewer (EK) and independently reviewed by a second (TS).

Any disagreement about study eligibility, data extraction and methodological quality between the two reviewers will be resolved through discussion until mutual consensus is achieved.

We will assess the methodological quality of all included studies using the CASP critical appraisal tool. This instrument consists of thirteen items assessing the randomisation, allocation, recruitment, blinding, sample size and analysis methods of studies.

The results of this will be categorised into a high-, moderate, or low methodological quality.

We will initially assess methodological heterogeneity by visual inspection of the data extraction tables and forest plots. If substantial heterogeneity is evident, the outcomes of the respective studies will form the basis of a thematic narrative review. If methodological homogeneity is demonstrated (population characteristics, intervention and outcome measurements), a meta-analysis will be deemed appropriate. In such cases statistical heterogeneity will be assessed using the Chi-squared and I-squared statistical tests. When p-value equates to less than 0.10 and I-squared to less than 20%, a fixed-effects model will be undertaken. When this is not satisfied, a random–effects model will be used. Continuous outcomes will be analysed using mean difference (MD) or standardised mean difference (SMD). Dichotomous outcomes will be analysed using odd ratio statistics. For each statistic, the estimated effect size, 95% confidence interval, and p-value will be presented.

A funnel-plot will be constructed of the primary outcome measurement to assess the effect of small sample size publication bias.

A sensitivity analysis of randomised controlled trial results and/or high methodological quality literature based on the CASP results is planned.

We plan to submit the findings of this review to a peer-review internation musculoskeletal, rheumatology or physiotherapy academic journal.

Toby Smith

Faculty of Medicine and Health Sciences

Queen's Building

University of East Anglia

Norwich, NR4 7TJ

United Kingdom

toby.smith@uea.ac.uk

University of East Anglia

www.uea.ac.uk

Dr Toby Smith, University of East Anglia, Norwich, UK
Mr Ed Kirby, West Essex Primary Care Trust, Epping, UK
Ms Leigh Davies, Norfolk and Norwich University Hospital, Norwich, UK

No other existing reviews exist on this topic.

06 August 2012

01 October 2012

None

None known

This systematic review title has not been registered elsewhere.

English

England

Subject indexing assigned by CRD

Exercise Therapy; Humans; Osteoarthritis, Knee

No further information is currently available.

This protocol has not been published elsewhere.

16 August 2012

14 December 2012

This paper has been submitted for peer-review in an international physiotherapy journal.