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Clinical Trials/NL-OMON56514
NL-OMON56514
Not yet recruiting
Not Applicable

Personalized RehabilitatiOn in severly Fatigued patients with Idiopathic inflammatory myopaThies: a pilot randomized controlled trial - PRO-FIT

Amsterdam UMC0 sites20 target enrollmentTBD
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Conditionsinflammatory myopathymyositis1000381610028302

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
inflammatory myopathy
Sponsor
Amsterdam UMC
Enrollment
20
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
Amsterdam UMC

Eligibility Criteria

Inclusion Criteria

  • •Age \>\=18 and \<68 years
  • •Idiopathic inflammatory myopathy according to EULAR/ACR criteria, except
  • •inclusion body myositis
  • •Disease duration \>\=12 months from diagnosis
  • •Severe fatigue as assessed by a score of \>\=35 on the subscale fatigue of the
  • •Checklist Individual Strength (CIS\-Fatigue)

Exclusion Criteria

  • •Unstable disease/evidence of disease activity as assessed by increase in
  • •dosage of immunosuppressant/modulating therapy/therapies \< 3 months
  • •Co\-morbidity interfering with the intervention or influencing outcomes, e.g.
  • •severe anaemia, abnormalities in thyroid function, or contraindications for
  • •being physically active according to the guidelines by the American College of
  • •Sports Medicine
  • •Unable to complete study questionnaires or interventions
  • •Participation in another trial interfering with the intervention or
  • •influencing outcomes

Outcomes

Primary Outcomes

Not specified

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