Exercise, cardiovascular disease and rheumatoid arthritis
| ISRCTN | ISRCTN04121489 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04121489 |
| Secondary identifying numbers | 10/H1206/59 |
- Submission date
- 05/09/2012
- Registration date
- 19/10/2012
- Last edited
- 19/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
Patients with rheumatoid arthritis (RA) have an increased risk of developing heart problems. In contrast, physical activity (PA) is generally accepted as one of the best ways to minimise this risk for heart disease. In such populations, PA promotion is primarily carried out via supervised, hospital-based exercise programmes. Although these exhibit short-term benefits, there is no compelling evidence for sustained participation in PA post-programme and long-term improvements in specific outcomes. The aim of this study is to investigate whether a physical activity intervention (treatment) can increase cardio-respiratory fitness. In addition we aim to test whether a psychological intervention encourages the adoption and maintenance of PA sufficient to provide sustained cardiovascular and personal well-being benefits in patients with RA.
Who can participate?
This study is aiming to recruit a total of 100 patients with RA, who attend the rheumatology clinics at the Dudley Rheumatology Department.
What does the study involve?
Participants will be randomly allocated to intervention and control group. At the beginning of the study you will be given a free 3 month subscription to a gym in Dudley. We will develop a specific 3 month exercise program for you based on your needs, preferences and at a time which is convenient for you. You will be asked to complete some assessments before you start the physical activity program, after you have finished the 3 months of training, 6 months and 1 year later. Participants in the intervention along with the 3 month exercise program they will be supplemented with two integrated psychological intervention strategies: firstly, the creation of an exercise environment (by the exercise instructors) and secondly, the provision of a one on one consultation with a SDT-trained counsellor. The assessments can be divided into following main groups:
Tests related to your disease activity and heart functioning
Questionnaires about your health status and views on exercise
Measures of physical activity
Exercise testing to see how fit you are
What are the possible benefits and risks of participating?
Completion of the exercise programme as part of this research may result in improved fitness of your heart and lungs and may also benefit your arthritis. Your personal physical activity training program will be constructed according to the latest scientific evidence and based on your individual needs by experienced exercise physiologists. The training sessions will be held in gym in Dudley where you will be given a free 3-month membership (usual cost approximately £40 per month). The information we will gather from all the people taking part will help us to understand the mechanisms that may be responsible for causing the heart problems in people with rheumatoid arthritis and help us to identify ways to reduce such problems. In the future we hope we will be able to apply this knowledge to many more people with rheumatoid arthritis. However helpful they may be, exercise programs may also carry some risks. Cases of falls, injuries, heart complications (such as heart attacks), even death, have been reported while exercising on less than 1 in 10,000 occasions - this is about 6 times less likely than you being hit by a car in your everyday life. All necessary precautions for this are routinely taken to minimise such risks in the gym where you will be doing your exercise sessions.
Where is the study run from?
This study has been set-up by the University of Birmingham in collaboration with the Dudley Group of Hospitals. The study is run from Russells Hall Hospital.
When is the studying starting and how long is it expecting to run for?
Recruitment for the study began in April 2011. You will be able to enrol on the study until March 2013.
Who is funding the study?
Funding has been provided by the Medical Research Council (National Prevention Research Initiative - Phase 3)
Who is the main contact?
Professor Joan Duda
j.l.duda@bham.ac.uk
Contact information
Scientific
Deputy Head of School
School of Sport and Exercise Sciences
College of Life and Environmental Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | An intervention fostering autonomous motivation, Physical Activity and cardiovascular fitness in Rheumatoid Arthritis (PARA) |
| Study acronym | PARA |
| Study hypothesis | It is hypothesized that both the control and experimental conditions will demonstrate an increase in cardiovascular fitness post three month exercise programme. However, it is hypothesized that psychological intervention will foster the adoption and maintenance of PA sufficient to provide sustained cardiovascular and personal well-being benefits in patients with RA. |
| Ethics approval(s) | Birmingham East, North and Solihull Research Ethics Committee, 03/02/2011 ref: 1-/H1206/59 |
| Condition | Rheumatoid Arthritis |
| Intervention | 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 experimental condition, the individualised 3 month exercise programme will be supplemented with two integrated psychological intervention strategies: firstly, the creation of an exercise environment (by the exercise instructors) that is more autonomy supportive, and secondly, the provision of an autonomy supportive one on one consultation with a SDT-trained counsellor. Our physical activity behavioural change counsellor will have one to one contact with each patient at 4 time points during the 3 month exercise programme (i.e., a 1 hr face to face consultation at programme induction, brief consultations via telephone at 1 and 2 months, and an approximately 30 min face to face consultation at 3 months), with a final telephone consultation at 5 months (i.e., 2 months following the end of the exercise intervention). |
| Intervention type | Behavioural |
| Primary outcome measure | Cardio-respiratory fitness, assessed using exercise tolerance testing (ETT) |
| Secondary outcome measures | 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. |
| Overall study start date | 02/03/2011 |
| Overall study end date | 31/03/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Participant inclusion criteria | Patients with Rheumatoid Arthritis (1987 ACR criteria) diagnosed in the past 10 years, without co-morbidities prohibiting exercise |
| Participant 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 |
| Recruitment start date | 01/04/2011 |
| Recruitment end date | 31/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
B15 2TT
United Kingdom
Sponsor information
University/education
Institute of Research and Development
Birmingham Research Park
Edgbaston
Birmingham
B15 2SQ
England
United Kingdom
| Website | http://www.birmingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 | 13/03/2015 | Yes | No | |
| Results article | results | 29/03/2017 | Yes | No |
Editorial Notes
19/10/2017: Publication reference added.
12/01/2016: Publication reference added.
