NCT00434200

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jan 1998

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
Last Updated

February 13, 2007

Status Verified

February 1, 2007

First QC Date

February 9, 2007

Last Update Submit

February 9, 2007

Conditions

Keywords

rheumatoid arthritisexercisedamage

Outcome Measures

Primary Outcomes (4)

  • 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 (5)

  • 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

Interventions

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis

You may not qualify if:

  • Prosthesis of a weight bearing joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 15479889BACKGROUND
  • 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.

    PMID: 15334432BACKGROUND
  • 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.

    PMID: 15077288BACKGROUND
  • 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.

    PMID: 13130460BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Johanna MW Hazes, PhD

    Erasmus Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

January 1, 1998

Study Completion

June 1, 2000

Last Updated

February 13, 2007

Record last verified: 2007-02