Long term physical activity in rheumatoid arthritis
| ISRCTN | ISRCTN25539102 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25539102 |
| Protocol serial number | 2010/1232-31/1 |
| Sponsor | Karolinska Institute |
| Funders | Swedish Research Council (Sweden), Combine Sweden (Sweden), Reumatikerförbundet, National Postgraduate School of Health Care Sciences (Sweden), Forskningsrådet om Hälsa, Arbetsliv och Välfärd |
- Submission date
- 29/12/2010
- Registration date
- 04/03/2011
- Last edited
- 14/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Rheumatoid arthritis is a long-term condition that causes pain, swelling and stiffness in the joints. People with rheumatoid arthritis have an increased risk of disability and premature death. A health-enhancing physical activity (HEPA) programme could help to reduce this risk. The aim of this study is to test a two-year HEPA programme in patients with rheumatoid arthritis.
Who can participate?
Patients aged 18 - 74 with rheumatoid arthritis
What does the study involve?
Participants take part in at least two 45-minute exercise sessions, including strength training and aerobic exercise, and are encouraged to perform additional moderate-intensity physical activity for at least 30 minutes on most of the other days of the week for one year. They also take part in regular support group meetings for one hour every other week. General health perception, pain, fatigue, muscle function and any cardiovascular events (e.g., heart attack) are measured at the start of the study and after one and two years.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Karolinska Institutet (Sweden)
When is the study starting and how long is it expected to run for?
January 2011 to January 2022
Who is funding the study?
1. Swedish Research Council (Sweden)
2. Combine Sweden (Sweden)
3. Swedish Rheumatism Association (Sweden)
4. National Postgraduate School of Health Care Sciences (Sweden)
Who is the main contact?
Prof Christina Helging Opava
christina.opava@ki.se
Contact information
Scientific
Karolinska Institutet
Department of Neurobiology, Care Sciences and Society
Division of Physiotherapy
23100
Huddinge
SE 14183
Sweden
 ORCID ID |
0000-0001-6738-4879 |
|---|---|
| christina.opava@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective cohort multi-centre trial |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Long term Physical Activity in Rheumatoid Arthritis - health perception, cardiovascular risk and underlying mechanisms related to inflammation, fatigue and pain |
| Study acronym | PARA 2010 |
| Study objectives | Current study hypothesis as of 13/01/2022: The overall aim of the present study is to investigate the implementation of a 2-year health-enhancing physical activity programme (HEPA), including strength training, among patients with rheumatoid arthritis (RA) and its outcome as regards general health perception, pain, fatigue, muscle function and cardiovascular events as well as relations between HEPA and mechanisms underlying low muscle performance, reduced muscle mass, systemic and local inflammation, pathophysiological pain mechanisms and cardiovascular function. Previous study hypothesis: The overall aim of the present study is to investigate the implementation of a 2-year health-enhancing physical activity programme (HEPA), including strength training, among patients with rheumatoid arthritis (RA) and its outcome as regards general health perception, pain, fatigue, muscle function and cardiovascular events as well as relations between HEPA and mechanisms underlying low muscle performance, reduced muscle mass, systemic and local inflammation, and pathophysiological pain mechanisms. |
| Ethics approval(s) | Approved 01/09/2009, Stockholm Regional Research Ethics Committee, ref: 2010/1232-31/1 Added 14/01/2022: Approved 01/09/2010, Stockholm Regional Research Ethics Committee, ref: 2010/1232-31/1 Approved 27/07/2011, Stockholm Regional Research Ethics Committee, ref: 2011/1241-32 Approved 26/04/2012, Stockholm Regional Research Ethics Committee, ref: 2012/769-32 |
| Health condition(s) or problem(s) studied | Rheumatology and physical therapy |
| Intervention | Each intervention participant will take part in at least two 45-minute exercise sessions, including strength training and aerobic exercise, and encouraged to perform additional moderate-intensity physical activity at least 30 minutes on most of the other days of the week for one year. They will also take part in regular support group meetings one hour every other week, which will be designed to increase their knowledge and strengthen their self-efficacy for adopting and maintaining HEPA. During the subsequent year, the participants will take increased responsibility for their own HEPA as well as for the support group meetings. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
General Health Perception Visual Analogue Scale (VAS), assessed at baseline and after one and two years respectively |
| Key secondary outcome measure(s) |
Each outcome will be assessed at baseline and after one and two years respectively: |
| Completion date | 14/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 1350 |
| Total final enrolment | 249 |
| Key inclusion criteria | 1. Rheumatoid arthritis according to American College of Rheumatology 1987 criteria 2. Aged between 18 - 74 years, either sex 3. Disease duration over one year 4. Independence in daily living 5. Recommended levels of health enhancing physical activity (HEPA) not currently reached |
| Key exclusion criteria | 1. Problems with speaking and understanding Swedish 2. Other major diseases preventing HEPA |
| Date of first enrolment | 15/01/2011 |
| Date of final enrolment | 09/10/2012 |
Locations
Countries of recruitment
- Sweden
Study participating centre
SE 14183
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as the June 2017 ICMJE statement was not valid at the time of data collection, and most of the results have been published already. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Pain substudy #I | 15/03/2018 | Yes | No | |
| Results article | Pain substudy #II | 26/11/2018 | Yes | No | |
| Results article | Cardiovascular substudy #I | 13/12/2017 | 12/01/2022 | Yes | No |
| Results article | Cardiovascular substudy #II | 25/05/2018 | 12/01/2022 | Yes | No |
| Results article | Cardiovascular substudy #III | 15/12/2021 | 12/01/2022 | Yes | No |
| Results article | Experiences of PA participation | 20/06/2014 | 12/01/2022 | Yes | No |
| Results article | PA intervention, 1 year | 27/11/2014 | 12/01/2022 | Yes | No |
| Results article | PA intervention, 2 years | 01/05/2018 | 12/01/2022 | Yes | No |
| Results article | Perceptions of PA maintenance | 07/12/2020 | 12/01/2022 | Yes | No |
| Protocol article | Study protocol | 01/06/2012 | Yes | No | |
| Other publications | Selection procedure | 01/05/2014 | 12/01/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/01/2022: Swedish Research Council was incorrectly named as the sponsor, the correct sponsor Karolinska Institutet was added. Ethics approval details added.
13/01/2022: The following changes were made to the trial record:
1. Forté Foundation was added as a funder.
2. Trial website and ORCID ID added.
3. The study hypothesis was updated.
12/01/2022: The following changes were made to the trial record:
1. Publication references, total final enrolment number, publication and dissemination plan, intention to publish date and IPD sharing statement added.
2. The recruitment end date was changed from 15/01/2022 to 09/10/2012.
3. The overall trial end date was changed from 15/01/2022 to 14/01/2015.
28/11/2018: Publication reference added.
19/03/2018: Publication reference added.
11/03/2016: Plain English summary added.
