Rheumatoid Arthritis Patients in Training - Full Text View

Sponsors and Collaborators:	Leiden University Medical Center Dutch Health Care Insurance Board
Information provided by:	Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00434200

Purpose

Aim of the study was to investigate the effectiveness (functional ability and physical capacity) and safety (disease activity and damage of the joints) of long-term high-intensity weight-bearing exercises in patients with rheumatoid arthritis (RA).The training proved to be safe and effective.

Condition	Intervention	Phase
Rheumatoid Arthritis	Procedure: long-term intensive exercise	Phase IV

MedlinePlus related topics: Exercise and Physical Fitness Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:

effectiveness:
primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months
safety:
damage of the large joints (Larsen score); each year

Secondary Outcome Measures:

effectiveness:
muscle strength (strength of extensors of the knee); each 3 months and
aerobic fitness (ergometer); each 3 months
Safety:
disease activity (DAS) each 3 months

Estimated Enrollment:	300
Study Start Date:	January 1998
Estimated Study Completion Date:	June 2000

Detailed Description:

The 300 patients with RA were randomized into two groups; exercise group and usual care group. The patients who participated in the 2 years intensive exercise training (2 times a week, training duration 65 minutes) improved their functional capacity and functional ability without detrimental effects on the large joints damage or on disease activity. Only patients with excessive large joint damage at baseline were at risk to develop additional damage when participating in intensive weight-bearing exercises. Patients who exercised were able to delay the decrease of bone mineral density of the hips.

Eligibility

Ages Eligible for Study:	17 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Rheumatoid arthritis

Exclusion Criteria:

Prosthesis of a weight bearing joint

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434200

Sponsors and Collaborators

Leiden University Medical Center

Dutch Health Care Insurance Board

Investigators

Principal Investigator:

Johanna MW Hazes, PhD

Erasmus Medical Centre

More Information

Publications:

de Jong Z, Munneke M, Zwinderman AH, Kroon HM, Ronday KH, Lems WF, Dijkmans BA, Breedveld FC, Vliet Vlieland TP, Hazes JM, Huizinga TW. Long term high intensity exercise and damage of small joints in rheumatoid arthritis. Ann Rheum Dis. 2004 Nov;63(11):1399-405.

de Jong Z, Munneke M, Jansen LM, Ronday K, van Schaardenburg DJ, Brand R, van den Ende CH, Vliet Vlieland TP, Zuijderduin WM, Hazes JM. Differences between participants and nonparticipants in an exercise trial for adults with rheumatoid arthritis. Arthritis Rheum. 2004 Aug 15;51(4):593-600.

de Jong Z, Munneke M, Lems WF, Zwinderman AH, Kroon HM, Pauwels EK, Jansen A, Ronday KH, Dijkmans BA, Breedveld FC, Vliet Vlieland TP, Hazes JM. Slowing of bone loss in patients with rheumatoid arthritis by long-term high-intensity exercise: results of a randomized, controlled trial. Arthritis Rheum. 2004 Apr;50(4):1066-76.

de Jong Z, Munneke M, Zwinderman AH, Kroon HM, Jansen A, Ronday KH, van Schaardenburg D, Dijkmans BA, Van den Ende CH, Breedveld FC, Vliet Vlieland TP, Hazes JM. Is a long-term high-intensity exercise program effective and safe in patients with rheumatoid arthritis? Results of a randomized controlled trial. Arthritis Rheum. 2003 Sep;48(9):2415-24.

de Jong Z, Munneke M, Jansen LM, Ronday K, van Schaardenburg DJ, Brand R, van den Ende CH, Vliet Vlieland TP, Zuijderduin WM, Hazes JM. Differences between participants and nonparticipants in an exercise trial for adults with rheumatoid arthritis. Arthritis Rheum. 2004 Aug 15;51(4):593-600.

Study ID Numbers:	OG-97-024
Study First Received:	February 9, 2007
Last Updated:	February 9, 2007
ClinicalTrials.gov Identifier:	NCT00434200
Health Authority:	Netherlands: Independent Ethics Committee

Keywords provided by Leiden University Medical Center:

rheumatoid arthritis
exercise
damage

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009