Rehabilitation of Patients with Rheumatoid Arthritis (RA): Changes in Muscle, Functional and Biochemical Parameters

ISRCTN	ISRCTN87704142
DOI	https://doi.org/10.1186/ISRCTN87704142
Secondary identifying numbers	PCD/A1/87

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 26/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Hurley
Scientific

Physiotherapy Division
Rehabilitation Research Unit
King's College London
King's Healthcare (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom

Phone	+44 (0)20 73466022
Email	mike.hurley@kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/04/1996
Completion date	01/07/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Both
Target number of participants	133
Key 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.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/04/1996
Date of final enrolment	01/07/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Physiotherapy Division

London
SE22 8PT
United Kingdom

Sponsor information

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

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

Website	http://www.doh.gov.uk

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2002		Yes	No