Condition category
Musculoskeletal Diseases
Date applied
18/07/2002
Date assigned
18/07/2002
Last edited
12/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.kcl.ac.uk/gppc/escape

Contact information

Type

Scientific

Primary contact

Dr Mike Hurley

ORCID ID

Contact details

Physiotherapy Division
King's College London
Rehabilitation Research Unit
King's Healthcare (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom
+44 (0)20 7346 6022
mike.hurley@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

H0599

Study information

Scientific title

Acronym

Study hypothesis

Primary hypothesis was that participation on the rehabilitation programme would improve function better than usual primary. Subsidiary hypotheses were that rehabilitation would be equally effective whether delivered to individuals or groups of people. Group rehabilitation would be more cost-effective than individual rehabilitation.

Ethics approval

Approval received from the local Research Ethics Committees (RECs) of
1. King's College, Guy's and St Thomas' (ref: 01-128)
2. The Lewisham Hospital NHS Trust (ref: 01/10/17)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Knee pain

Intervention

The rehabilitation regime is supervised by a research worker who has not performed that particular patient's assessment. The exercise regime consists of 12 x 30 minutes supervised exercise sessions, two a week for 6 weeks. The classes will be closely supervised by the applicant or research assistant, and performed on individual patients or in groups of eight patients who will rotate around exercise stations and will involve:

1. 24 isometric quadriceps: Maximal Voluntary Contractions (MVCs) will be performed with the patients seated and their knees flexed at 90°F as described in the quadriceps strength assessment. The MVCs will be performed in four groups of six MVCs, each contraction will be maintained for about 4 seconds and each group of six contractions separated by 1 minute rest to minimise fatigue. Vigorous verbal encouragement and visual feedback from the computer screen will facilitate maximum effort. All the contractions will be voluntary, no electrical stimulation will be used.
2. Five minute on a static exercise bike: Initially the patients will pedal without resistance, but after two to three sessions resistance to pedalling will be increased to increase quadriceps strength.
3. One minute of isotonic knee extension (concentric quadriceps contractions) and flexion (eccentric quadriceps contractions) to 90°F, using therapeutic resistance bands to increase quadriceps strength and dynamic control.
4. Three 'functional' exercises (eg sit/stand, step-ups, step-downs) and three balance/co-ordination exercises (unilateral stance, balance boards) will each be performed for one minute. As the quantity and quality of the exercises improve they will be progressed by increasing the number of repetitions or resistance (e.g. sit/stand from lower chair, step-ups on to higher block) and more challenging exercises were introduced (e.g. unilateral stance on balance board).

Self-care advice:
All patients attending the exercise sessions (whether treated individually or in small groups) will receive arthritis self-care advice emphasising: the importance of regular controlled exercise; methods of controlling joint pain, eg cold and heat packs; joint protection; medication; problem solving and planning to promote adoption of lifestyle changes to promote joint health, ie the importance of weight loss, incorporation of regular exercise into daily routine. This will be provided by the research worker supervising the exercise, who will answer specific questions, and will be reinforced with written information.

Discharge policy:
After 12 rehabilitation exercise sessions (the primary outcome measure end-point) the patients will be discharged with specific advice and written instructions to perform a simple, home exercise programme consisting of four exercises they are familiar with performing during their rehabilitation. The total exercising time will be about 15 min, three times a week. In addition, they will be supplied with contact addresses where the patients can exercise in the community.

Changes in the intervention group will be compared with changes in the control patients who remain under routine GP management.

Data Analysis Plan:
Cluster randomisation requires that analyses take into account clustering, if the individual patient is chosen as the unit of analysis (which maximises power); this is most effectively done by multilevel modelling (level 1 = participants; level 2 = GP surgeries). Cluster randomisation is less likely than individual randomisation to achieve adequate balance in patient and cluster characteristics, and multilevel modelling also allows such potential confounding factors to be modelled.

Outcomes are measured at baseline, at 6 weeks (ie end of the intervention or control period) and 6 months after the end of the intervention. These ‘repeated measures’ will be represented as a further level of clustering (measurements within participants) in a multilevel model. Multilevel modelling accommodates missing data for repeated measures efficiently, maximising the power of the analyses and the available information about outcome. The analytic framework of multilevel modelling can be extended to binary variables.

Outcome measures at baseline and at the 6-month follow-up assessment will be summarised using appropriate descriptive statistics. Primary analyses will be by intention-to treat. The level of significance will be set at P<0.05. The effect of the intervention on the primary outcome [function-WOMAC(func)] will be assessed, first, by investigating whether outcomes differ significantly overall by groups and, second, by carrying out paired comparisons between (a) the individually treated patients and control group and (b) patients treated in classes and control group if overall significant differences by group are observed. These analyses will be adjusted for baseline measures. No test of the interaction between time of outcome measurement and intervention group is planned.

The following additional analyses are planned. Two tests of interaction will be carried out to investigate whether the effect of intervention is influenced by (a) depression or (b) self-efficacy. For all outcomes, both unadjusted (adjusting only for the baseline measure) and adjusted analyses (adjusting for other potential confounding factors) will be carried out; the latter will be interpreted as ‘sensitivity analyses’ to explore the robustness of the unadjusted analyses to possible confounding. Finally, process variables characterising the success with which the intervention was delivered (eg compliance) will be included in analyses of WOMAC(func) only, in order to interpret better the overall effects of the intervention.

Economic evaluation:
The primary economic evaluation will be a cost-effectiveness analysis comparing changes in the primary outcome [WOMAC(func)] and total societal costs for each group. The secondary economic evaluation will be a cost-utility analysis based on utility weights associated with EuroQol health states. Cost-effectiveness acceptability curves will be employed for both the cost-effectiveness and cost-utility analyses in order to better inform decisions about the relative cost-effectiveness of the three treatments.

Supplementary evaluation will take the form of a cost-consequences analysis, examining total and component costs alongside all outcomes.

The data analyses would be conducted in a manner consistent with those employed in the clinical evaluation (for example, on an intention-to-treat basis, and adopting the same conventions with respect to cluster randomisation, missing items scores, missing observations etc.). Cost differences between groups will be tested using the Student's t-test. Cost data are often skewed, violating the normality assumption underpinning the validity of the t-test. If this is the case, bootstrap replications of the original data will be performed to check the robustness of the t-test results. Sensitivity analyses will be performed to check the assumptions made in the cost calculations and analyses.

In addition, the EuroQoL will enable calculation of cost per quality adjusted life year (QALY) for the interventions.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Self-reported functioning Western Ontario and McMasters University Osteoarthritis Index (WOMAC) sub-score for physical function 6 months after completing rehabilitation.

Secondary outcome measures

1. Aggregated functional performance time (AFPT) 18
2. Exercise health beliefs and self-efficacy questionnaire (ExBeliefs) 19
3. Hospital Anxiety and Depression Scales
4. Self-reported health status EuroQoL
5. Condition specific patient preference health related quality of life questionnaire (McMaster Toronto Arthritis, MACTAR)
6. Quadriceps strength and voluntary activation
7. Costs of rehabilitation evaluated using Client Services Receipt Inventory

Overall trial start date

01/01/2000

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients who have attended their General Practitioner (GP) practice complaining of knee pain and for whom the GP feels that some intervention is appropriate
2. Patients who give informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

418

Participant exclusion criteria

1. Lower limb arthroplasty
2. Physiotherapy for knee pain in preceding 12 months
3. Intra-articular injections in preceding 6 months
4. Unstable medical conditions
5. Unable/unwilling to exercise
6. Severe lack of mobility
7. Unable to understand English

Recruitment start date

01/01/2000

Recruitment end date

31/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy Division
London
SE22 8PT
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
+44 (0)1246 558033
info@arc.org.uk

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Arthritis Research UK (UK) - (previously Arthritis Research Campaign [ARC])

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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. 2007 main results in http://www.ncbi.nlm.nih.gov/pubmed/17907147
2. 2007 results of economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/17907207
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20149236

Publication citations

  1. Main results

    Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Patel A, Williamson E, Jones RH, Dieppe PA, Reeves BC, Clinical effectiveness of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain: a cluster randomized trial., Arthritis Rheum., 2007, 57, 7, 1211-1219, doi: 10.1002/art.22995.

  2. Results of economic evaluation

    Hurley MV, Walsh NE, Mitchell HL, Pimm TJ, Williamson E, Jones RH, Reeves BC, Dieppe PA, Patel A, Economic evaluation of a rehabilitation program integrating exercise, self-management, and active coping strategies for chronic knee pain., Arthritis Rheum., 2007, 57, 7, 1220-1229, doi: 10.1002/art.23011.

  3. Results

    Hurley MV, Walsh N, Bhavnani V, Britten N, Stevenson F, Health beliefs before and after participation on an exercised-based rehabilitation programme for chronic knee pain: doing is believing., BMC Musculoskelet Disord, 2010, 11, 31, doi: 10.1186/1471-2474-11-31.

Additional files

Editorial Notes