CClinicalTrials.gg
Status unknownNCT00434200RAPITUpdated Feb 13, 2007

Rheumatoid Arthritis Patients in Training

A Phase 4 interventional study of long-term intensive exercise in Rheumatoid Arthritis, sponsored by Leiden University Medical Center. Status unknown. Open to participants aged 17 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-02-13.

Sponsored by Leiden University Medical Center · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
17 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • rheumatoid arthritis
  • exercise
  • damage
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 300 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Rheumatoid arthritis

Exclusion criteria

Exclusion Criteria:

  • Prosthesis of a weight bearing joint
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
300 participants

Interventions

  • Procedurelong-term intensive exercise
06

What researchers measure

Primary outcomes

  1. effectiveness:

  2. primary outcome:functional ability;MACTAR;6 months, 12 months, 18 months, 24 months

  3. safety:

  4. damage of the large joints (Larsen score); each year

Secondary outcomes

  1. effectiveness:

  2. muscle strength (strength of extensors of the knee); each 3 months and

  3. aerobic fitness (ergometer); each 3 months

  4. Safety:

  5. disease activity (DAS) each 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 15479889 ↗
  • 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. PubMed 15334432 ↗
  • 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. PubMed 15077288 ↗
  • 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. PubMed 13130460 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00434200
Lead sponsor
Leiden University Medical Center
Collaborators
Dutch Health Care Insurance Board
First posted
Feb 13, 2007
Start date
Jan 1998
Completion
Jun 2000
Last update
Feb 13, 2007

Study contacts

Johanna MW Hazes, PhD
principal investigator · Erasmus Medical Centre
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion