Physical Activity in Rheumatoid Arthritis: a randomised controlled multi-centre study
| ISRCTN | ISRCTN88886304 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88886304 |
| Protocol serial number | N/A |
| Sponsor | Karolinska Institutet (Sweden) |
| Funders | The Swedish Research Council (Sweden), The Vårdal Foundation (Sweden), The Swedish Rheumatism Association (Sweden), The Västerbotten County Council Research Fund (Sweden), The Stockholm County Council (EXPO) (Sweden), The Health Care Science Postgraduate School at Karolinska Institutet (Sweden) |
- Submission date
- 21/12/2006
- Registration date
- 28/12/2006
- Last edited
- 25/09/2019
- 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
Prof Christina Opava
Scientific
Scientific
Department Of NSV
Division of Physiotherapy
ANA 23100
Huddinge
SE-14183
Sweden
| Phone | +46 (0)85 24 88 880 |
|---|---|
| christina.opava@ki.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single blind randomised controlled trial with intervention group and control group. |
| Secondary study design | Randomised controlled trial |
| Scientific title | Physical Activity in Rheumatoid Arthritis: a randomised controlled multi-centre study |
| Study acronym | PARA study |
| Study objectives | 1. A one-year support program for healthy physical activity will: a. increase/maintain physical activity levels b. improve health-related quality of life and functioning c. be cost-effective 2. Improvements will sustain one year after end of intervention. 3. Clusters of characteristics (demographic, disease-related, cognitive-behavioural and body functions) can be distinguished and related to health-related quality of life and physical activity behavior respectively. |
| Ethics approval(s) | Regional Research Ethics committee, Karolinska Institutet (ref: d.nr. 00-010). |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis according to American College of Rheumatology criteria |
| Intervention | All participants in both groups had access to, but were not specifically encouraged to participate in, 'ordinary physical therapy treatment' including patient education, treatment with physical modalities, and organised exercise a maximum of twice per week. This was the treatment generally offered to patients with RA, which seldom resulted in regular physical activity in daily life. Those randomised to intervention furthermore underwent a one-year program aiming at implementing healthy physical activity (moderately intensive, 30 minutes/day, more than four days/week). They were individually coached by a physical therapist and were informed about the benefits of physical activity. Their thoughts about their body function and their possibilities for physical activity were discussed. Goal setting for their physical activity behaviours were formulated and documented according to a structured manual based on the principles of graded activity training. Perceived obstacles to a successful implementation were discussed and problem-solving strategies to help overcome present and future barriers were discussed and documented. Continuous telephone support was given after one week and then once monthly by the physical therapist. Tests of body functions were performed every third month as part of the intervention and oral and written feedback given about the test results. Activity logs were used two weeks prior to each test occasion to support adherence. Goals related to physical activity behaviour were systematically evaluated and adjusted whenever required. |
| Intervention type | Other |
| Primary outcome measure(s) |
The EuroQoL 5 dimensions (EQ-5D) |
| Key secondary outcome measure(s) |
1. The Grippit for maximum grip strength |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 182 |
| Key inclusion criteria | 1. Rheumatoid arthritis according to American College of Rheumatology criteria 2. Less than two years since diagnosis 3. Ability to undergo body function testing and answer questionnaires |
| Key exclusion criteria | Not applicable |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Department Of NSV
Huddinge
SE-14183
Sweden
SE-14183
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | sub-study results | 01/12/2018 | 25/09/2019 | Yes | No |
Editorial Notes
25/09/2019: Publication reference added.
