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Rheumatoid Arthritis Patients in Training (RAPIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Leiden University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Dutch Health Care Insurance Board
Information provided by:
Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT00434200
First received: February 9, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA

Resource links provided by NLM:

U.S. FDA Resources

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:

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

Keywords provided by Leiden University Medical Center:
rheumatoid arthritis
exercise
damage

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

ClinicalTrials.gov processed this record on June 18, 2013