Condition category
Musculoskeletal Diseases
Date applied
21/12/2006
Date assigned
28/12/2006
Last edited
12/01/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christina Opava

ORCID ID

Contact details

Department Of NSV
Division of Physiotherapy
ANA 23100
Huddinge
SE-14183
Sweden
+46 (0)85 24 88 880
christina.opava@ki.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PARA study

Study hypothesis

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

Regional Research Ethics committee, Karolinska Institutet (ref: d.nr. 00-010).

Study design

Single blind randomised controlled trial with intervention group and control group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The EuroQoL 5 dimensions (EQ-5D)

Secondary outcome measures

1. The Grippit for maximum grip strength
2. The Timed Stands Test for lower extremity function

Overall trial start date

01/01/2000

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

91 per group (beta=0.2, alfa=0.05)

Participant exclusion criteria

Not applicable

Recruitment start date

01/01/2000

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Sweden

Trial participating centre

Department Of NSV
Huddinge
SE-14183
Sweden

Sponsor information

Organisation

Karolinska Institutet (Sweden)

Sponsor details

-
Stockholm
SE-17177
Sweden
+46 (0)852 480 000
admin@ki.se

Sponsor type

Hospital/treatment centre

Website

http://ki.se/ki/jsp/polopoly.jsp?d=130&l=sv

Funders

Funder type

Research council

Funder name

The Swedish Research Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Vårdal Foundation (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Swedish Rheumatism Association (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Västerbotten County Council Research Fund (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Stockholm County Council (EXPO) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Health Care Science Postgraduate School at Karolinska Institutet (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

Publication citations

Additional files

Editorial Notes