Rheumatoid Arthritis Patients in Training

Rheumatoid Arthritis Clinical Trial

— RAPIT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00434200
• Other study ID #: OG-97-024
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 9, 2007
• Last updated: February 9, 2007
• Start date: January 1998
• Est. completion date: June 2000

Study information

• Verified date: February 2007
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

• Rheumatoid arthritis

Exclusion Criteria:

• Prosthesis of a weight bearing joint

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Procedure:
• long-term intensive exercise

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	Dutch Health Care Insurance Board

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness:
Primary	primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months
Primary	safety:
Primary	damage of the large joints (Larsen score); each year
Secondary	effectiveness:
Secondary	muscle strength (strength of extensors of the knee); each 3 months and
Secondary	aerobic fitness (ergometer); each 3 months
Secondary	Safety:
Secondary	disease activity (DAS) each 3 months