Clinical trial NCT00434200: Rheumatoid Arthritis Patients in Training
Official title: Interventional Study on the Effectiveness and Safety of Intensive Exercise in Patients With RA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
exercise
damage
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Health Care Insurance Board
First posted: 2007-02-13
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* Prosthesis of a weight bearing joint

Primary outcomes:
measure: effectiveness:
measure: primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months
measure: safety:
measure: damage of the large joints (Larsen score); each year
Secondary outcomes:
measure: effectiveness:
measure: muscle strength (strength of extensors of the knee); each 3 months and
measure: aerobic fitness (ergometer); each 3 months
measure: Safety:
measure: disease activity (DAS) each 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Erasmus Medical Centre
name: Johanna MW Hazes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/ard.2003.015826.
citation: 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. doi: 10.1002/art.20531.
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. doi: 10.1002/art.20117.
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. doi: 10.1002/art.11216.