Rehabilitation of Patients with Rheumatoid Arthritis (RA): Changes in Muscle, Functional and Biochemical Parameters
ISRCTN | ISRCTN87704142 |
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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
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 |
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mike.hurley@kcl.ac.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
SE22 8PT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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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 | |
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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? |
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Results article | results | 01/02/2002 | Yes | No |