Condition category
Musculoskeletal Diseases
Date applied
29/12/2010
Date assigned
04/03/2011
Last edited
09/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

http://www.swerre.se/cms/sv/PARA2010

Contact information

Type

Scientific

Primary contact

Prof Christina Helging Opava

ORCID ID

Contact details

Karolinska Institutet
Department of Neurobiology
Care Sciences and Society
Division of Physiotherapy
23100
Huddinge
SE 14183
Sweden
-
christina.opava@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010/1232-31/1

Study information

Scientific title

Long term Physical Activity in Rheumatoid Arthritis - health perception, cardiovascular risk and underlying mechanisms related to inflammation, fatigue and pain

Acronym

PARA 2010

Study hypothesis

The overall aim of the present study is to investigate the implementation of a two-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

Stockholm Regional Research Ethics Committee, 01/09/2009, ref: 2010/1232-31/1

Study design

Prospective cohort multi-centre trial

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

General Health Perception Visual Analogue Scale (VAS), assessed at baseline and after one and two years respectively

Secondary outcome measures

Each outcome will be assessed at baseline and after one and two years respectively:
1. Pain
2. Fatigue
3. Fear avoidance beliefs
4. Exercise self-efficacy
5. Muscle function
6. Aerobic capacity
7. Systemic and local inflammatory activity
8. Pain sensitivity
9. Cardiovascular events

Overall trial start date

15/01/2011

Overall trial end date

15/01/2022

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450 for intervention, 900 matched controls

Participant exclusion criteria

1. Problems with speaking and understanding Swedish
2. Other major diseases preventing HEPA

Recruitment start date

15/01/2011

Recruitment end date

15/01/2022

Locations

Countries of recruitment

Sweden

Trial participating centre

Karolinska Institutet
Huddinge
SE 14183
Sweden

Sponsor information

Organisation

Swedish Research Council (Sweden)

Sponsor details

Klarabergsviadukten 82
Box 1035
Stockholm
SE 101 38
Sweden

Sponsor type

Research council

Website

http://www.vr.se/

Funders

Funder type

Research council

Funder name

Swedish Research Council (Sweden)

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

Funder name

Combine Sweden (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Rheumatism Association (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Postgraduate School of Health Care Sciences (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22656861

Publication citations

  1. Protocol

    Nordgren B, Fridén C, Demmelmaier I, Bergström G, Opava CH, Long-term health-enhancing physical activity in rheumatoid arthritis--the PARA 2010 study., BMC Public Health, 2012, 12, 397, doi: 10.1186/1471-2458-12-397.

Additional files

Editorial Notes

11/03/2016: Plain English summary added.