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Rheumatoid Arthritis Patients in Training (RAPIT)

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

long-term intensive exercise

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, exercise, damage

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Rheumatoid arthritis

Exclusion Criteria:

Prosthesis of a weight bearing joint

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

NCT ID

NCT00434200

First Posted

February 9, 2007

Last Updated

February 9, 2007

Sponsor

Leiden University Medical Center

Collaborators

Dutch Health Care Insurance Board

1. Study Identification

Unique Protocol Identification Number

NCT00434200

Brief Title

Rheumatoid Arthritis Patients in Training

Acronym

RAPIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Leiden University Medical Center

Collaborators

Dutch Health Care Insurance Board

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

rheumatoid arthritis, exercise, damage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

long-term intensive exercise

Primary Outcome Measure Information:

Title

effectiveness:

Title

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

Title

safety:

Title

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

Secondary Outcome Measure Information:

Title

effectiveness:

Title

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

Title

aerobic fitness (ergometer); each 3 months

Title

Safety:

Title

disease activity (DAS) each 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

17 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johanna MW Hazes, PhD

Organizational Affiliation

Erasmus Medical Centre

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

15479889

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.

Results Reference

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PubMed Identifier

15334432

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.

Results Reference

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PubMed Identifier

15077288

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.

Results Reference

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PubMed Identifier

13130460

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.

Results Reference

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Rheumatoid Arthritis Patients in Training

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