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
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
-
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.