A pragmatic randomised controlled trial of hydrotherapy and land exercises on global well-being in patients with rheumatoid arthritis (RA).

INTERVENTION: Men and women aged 18 years or older with RA (meeting American College of Rheumatology criteria) attending the Rheumatology out‐patient department will be invited to participate. Many patients with RA may have previously received physiotherapy or hydrotherapy treatment. To reduce carry over effects, those having either physiotherapy or hydrotherapy, for any reason, in the previous 6 months will be excluded. Patients attending the Rheumatology out‐patient department with rheumatoid arthritis will be provided with a patient information leaflet (providing information about the study) and invited to complete a short screening questionnaire. Patients will be asked to express their interest in participating in the study at the end of the screening questionnaire. Patients will be asked to return this completed form to the Selly Oak Hospital Physiotherapy Department in the stamped addressed envelope provided. Patients interested in participating will then be asked to attend for physiotherapy assessment. The physiotherapist will carry out a full physical assessment and apply inclusion and exclusion criteria. Patients not interested in the study, or who do not meet criteria, will he offered physiotherapy in the usual way as judged appropriate by the assessing physiotherapist. Those who are uncertain will be given an opportunity to discuss the study and will then be included if they meet the criteria and wish to be involved. Suitable patients will be asked for informed consent in writing and given a signed copy for their records. Staff in the department of physiotherapy will make all initial assessments. However treatments in the study will be managed by one of two senior physiotherapists. These staff will make equal contributions to land exercises and hydrotherapy. Interventions The interventions have been designed to compare the effects of water immersion with exercise with land exercise. In all cases, patients will be treated once a week for 6 successive weeks. Each s CONDITION: Musculoskeletal Diseases: Rheumatoid arthritis (RA) ; Musculoskeletal Diseases ; Rheumatoid arthritis (RA) PRIMARY OUTCOME: A research assistant blind to treatment allocation will collect initial and final outcome measurements. ; Primary Outcome measure: the proposed primary outcome measures change in self‐rated global impression, a validated measure of treatment effect. This measure has previously been used in clinical trials of exercise in fibromyalgia and chronic fatigue syndrome. Effect of treatment is measured as change on a 7‐point scale ranging from 1 (very much worse) to 7 (very much better). Participants scoring 6 or 7 will be regarded as responders and others as non‐responders. SECONDARY OUTCOME: Secondary outcome measures will include: ; ‐ Pain measured on a 10 cm visual analogue scale; ‐ Physical function based on the health assessment questionnaire (HAQ score), 10 metre walk speed and quality of life measured by the first part of the Euroqol EQ‐SD questionnaire that records problems in five domains (mobility, self‐care, usual activities, pain/discomfort and anxiety/depression).; ; Tertiary outcomes:; We propose to compare cost‐effectiveness of hydrotherapy and land exercises by using data from secondary outcome measures collected, particularly utility scores calculated from EQ‐SD and nationally available sources on the cost of health services. INCLUSION CRITERIA: a. Invitation ‐ potential volunteers will be invited to participate when they attend their Rheumatology out‐patient appointment sessions. They will be provided with a "Patient Information Leaflet" and a short screening Questionnaire with a section to state their interest in participation b. Consent ‐ Informed consent for participation in the study will be sought from all volunteers and consent forms will be completed. A copy of this form will be retained by each patient. c. Patient Selection: INCLUSION CRITERIA: 1. Ability to understand the purpose of the study, give informed consent in writing and follow simple instructions 2. Age >18 years 3. Stable disease modifying drugs for 6 weeks before study entry 4. No injected steroids 4 weeks prior to study entry 5. Stable non‐steroidal anti‐inflammatory drugs for 2 weeks before entry 6. No surgery 3 months preceding study or planned surgery within 3 months of entry 7. Functional cla