Skip to main content
Clinical Trials/NCT00434200
NCT00434200
Unknown
Phase 4

Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA

Leiden University Medical Center0 sites300 target enrollmentJanuary 1998

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Leiden University Medical Center
Enrollment
300
Primary Endpoint
effectiveness:
Last Updated
19 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1998
End Date
June 2000
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Leiden University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Rheumatoid arthritis

Exclusion Criteria

  • Prosthesis of a weight bearing joint

Outcomes

Primary Outcomes

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 Outcomes

  • 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

Similar Trials