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Rheumatoid Arthritis Patients in Training (RAPIT)

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ClinicalTrials.gov Identifier: NCT00434200
Recruitment Status : Unknown
Verified February 2007 by Leiden University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 13, 2007
Last Update Posted : February 13, 2007
Dutch Health Care Insurance Board
Information provided by:
Leiden University Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Procedure: long-term intensive exercise Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA
Study Start Date : January 1998
Estimated Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. effectiveness:
  2. primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months
  3. safety:
  4. damage of the large joints (Larsen score); each year

Secondary Outcome Measures :
  1. effectiveness:
  2. muscle strength (strength of extensors of the knee); each 3 months and
  3. aerobic fitness (ergometer); each 3 months
  4. Safety:
  5. disease activity (DAS) each 3 months

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Ages Eligible for Study:   17 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Rheumatoid arthritis

Exclusion Criteria:

  • Prosthesis of a weight bearing joint

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00434200

Sponsors and Collaborators
Leiden University Medical Center
Dutch Health Care Insurance Board
Principal Investigator: Johanna MW Hazes, PhD Erasmus Medical Centre

ClinicalTrials.gov Identifier: NCT00434200     History of Changes
Other Study ID Numbers: OG-97-024
First Posted: February 13, 2007    Key Record Dates
Last Update Posted: February 13, 2007
Last Verified: February 2007

Keywords provided by Leiden University Medical Center:
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases