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

• Conditions: inflammatory myopathy; myositis; 10003816; 10028302

• Registration Number: NL-OMON56514
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the change in daily functioning from baseline to<br /><br>directly post-intervention, as assessed by the performance score of the<br /><br>Canadian Occupational Performance Measure (COPM).</p><br>