This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment long-term intensive exercise
Phase phase 4
Sponsor Leiden University Medical Center
Collaborator Dutch Health Care Insurance Board
Start date January 1998
End date June 2000
Trial size 300 participants
Trial identifier NCT00434200, OG-97-024


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 17 years up to 70 years old.

Inclusion Criteria: - Rheumatoid arthritis Exclusion Criteria: - Prosthesis of a weight bearing joint

Additional Information

Official title Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA
Principal investigator Johanna MW Hazes, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by Leiden University Medical Center.