Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
26/11/2009
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

Dr Michael Hurley

ORCID ID

Contact details

Physiotherapy Division
Rehabilitation Research Unit
King's College London
King's Healthcare (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom
+44 (0)20 73466022
mike.hurley@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PCD/A1/87

Study information

Scientific title

Acronym

Study hypothesis

Rheumatoid arthritis is a extremely debilitating condition that attacks and destroys synovial joints. Atrophy of muscles acting across damaged joints is a common clinical feature of RA and contributes to disability. Although physiotherapy is frequently requested to improve strength and function, its efficacy is uncertain. Moreover, recent research has suggested reperfusion-injury following exercise of RA joints maybe one of the mechanisms of joint destruction. The objectives of the research were:
1. To compare the differences in lower and upper limb sensorimotor function, functional performance and patient-reported disability between healthy subjects and patients with rheumatoid arthritis (RA).
2. To investigate the effect of a brief, clinically applicable course of exercise rehabilitation on these variables and establish whether rehablitation exacerbates disease activity. Separate knee and elbow trials were conducted.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Arthritis (rheumatoid)

Intervention

The intervention consisted of 10 exercise sessions (twice a week for 5 weeks) at a hospital out-patient department. Exercises were tailored to address each individual patient's disabilities.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Knee Study: Isometric quadriceps strength
2. Elbow Study: Elbow flexor strength

Secondary outcome measures

1. Knee Study:
1.1. Voluntary quadriceps activation
1.2. Knee joint position sense
1.3. 4 common activities of daily living
1.4. Health Assessment Questionnaire (HAQ)
1.5. Disease Repercussion Profile
1.6. Clinical measures if disease activity in RA
1.7. Serum concentrations of IL-1, IL-6, TNF-alpha

2. Elbow Study:
2.1. Voluntary flexor activation
2.2. Elbow joint position sense
2.3. HAQ
2.4. Arthritis Impact Measurement Scale-2
2.5. Clinical measures of disease activity

Overall trial start date

01/04/1996

Overall trial end date

01/07/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with knee and elbow rheumatoid arthritis.
1. Knee study: 133 participants were recruited to the cross-sectional study, 108 RA patients and 25 healthy participants. 93 patients were recruited to the rehabilitation trial.
2. Elbow study: 21 participants were recruited to the cross-sectional study, 12 patients with RA and 9 healthy participants. These 12 patients participated in the rehabilitation study.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

133

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/1996

Recruitment end date

01/07/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy Division
London
SE22 8PT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Physical and Complex Disabilities National Research and Development Programme (UK)

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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11886964

Publication citations

  1. Results

    Bearne LM, Scott DL, Hurley MV, Exercise can reverse quadriceps sensorimotor dysfunction that is associated with rheumatoid arthritis without exacerbating disease activity., Rheumatology (Oxford), 2002, 41, 2, 157-166.

Additional files

Editorial Notes