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Exercise, cardiovascular disease and rheumatoid arthritis

An intervention fostering autonomous motivation, Physical Activity and cardiovascular fitness in Rheumatoid Arthritis (PARA)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN04121489
Enrollment
100
Registered
2012-10-19
Start date
2011-04-01
Completion date
Unknown
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis Musculoskeletal Diseases Other rheumatoid arthritis

Interventions

Psychological Intervention versus Active Control. Patients in both the active control condition and experimental condition will engage in a 3 month exercise programme. For the patients in the experim

Sponsors

University of Birmingham (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with Rheumatoid Arthritis (1987 ACR criteria) diagnosed in the past 10 years, without co-morbidities prohibiting exercise

Exclusion criteria

Exclusion criteria: 1. Fibromyalgia, recent joint surgery (in the preceding 6 months) 2. Recent DMARD or oral steroid changes (in the preceding 3 months) 3. Parenteral steroid administration (in the preceding 3 months) 4. Inability to exercise or follow advice 5. Comorbidity incompatible with exercise as per ACSM guidelines - absolute contraindications include: 5.1. Recent acute cardiac event 5.2. Unstable angina 5.3. Uncontrolled dysrythmias causing symptoms or haemodynamic compromise 5.4. Symptomatic aortic stenosis 5.5. Uncontrolled symptomatic heart failure 5.6. Acute pulmonary embolus 5.7. Acute myocarditis or pericarditis 5.8. Suspected or known dissecting aneurism and acute systemic infection 6. Relative contraindications include: 6.1. Left main coronary stenosis 6.2. Moderate stenotic valvular heart disease 6.3. Outflow tract obstruction 6.4. High degree AV block 6.5. Ventricular aneurysm 6.6. Uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxoedema) 6.7. Uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis) 6.8. Mental or physical impairment leading to inability to exercise adequately 7. Patients with relative contraindications may be included, after careful consideration of the risk/benefit ratio, especially if they are asymptomatic at rest

Design outcomes

Primary

MeasureTime frame
Cardio-respiratory fitness, assessed using exercise tolerance testing (ETT)

Secondary

MeasureTime frame
1. Physiological outcomes: BMI, BP and the anlaysis of blood samples for serological risk factors, lips, oxidative stress, von Willebrand factor (vWF), thrombotic variables, and vascular function. In addition detailed analyses of inflammation will include relevant cytokines and pseudopod formation. 2. Physical activity related outcomes: Physical activity behaviour (Actigraph), self reported PA (IPAQ), Self-efficacy, perceptions of autonomy support from the fitness instructor and PA advisor (i.e., the Health Care Climate Questionnaire), perceptions of autonomy support from important others (i.e., Important Other Climate Questionnaire), perceived competence, autonomy and relatedness with regards to physical activity participation (i.e., Psychological Need Satisfaction in Exercise Scale) and motivational regulations for exercise (i.e., the Behavioural Regulation in Exercise Questionnaire). 3. Health-related outcomes: Physical function (i.e., Stanford Health Assessment), Anxiety and Depression (i.e., Hospital Anxiety and Depression Scale), Subjective vitality, Multidimensional Assessment of Fatigue Scale, McGill Pain Questionnaire, Pittsburgh Sleep Quality Index, Revised UCLA Loneliness Scale, Health related quality of life, ICECAP-A and economic costs questionnaires.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 18, 2026