CFS_CARE- Care Concept for Patients with Myalgic Encephalo-myelitis/Chronic Fatigue Syndrome/ (ME/CFS)

Not Applicable

• Conditions: G93.3; Postviral fatigue syndrome

• Registration Number: DRKS00026960
• Lead Sponsor: Charité Universitätsmedizin Berlin - Institut für Medizinische Immunologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

CFS within 5 years of onset, Bell score 30-70, Canadian consensus criteria met, 18-65 years, ability to consent, BKK insured.

Exclusion Criteria

Other conditions associated with chronic fatigue e.g. fatigue after cancer

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical dimension of the SF36 measured 12 months after study inclusion.

Secondary Outcome Measures

Name	Time	Method
- Bell disability scale (at 0, 3, 6, 9, 12 months)<br>- Chalder fatigue scale (at 0, 3, 6, 9, 12 months)<br>- CCC criteria (at 0, 3, 6, 9, 12 months)<br>- COMPASS31 scale (at 0, 3, 6, 9, 12 months in the intervention group, at 6 and 12 months in the control group)<br>- Hand strength month 0 and 12<br>- Schellong test month 0 and 12<br>- Step counts measured with pedometer at 0, 6 and 12 months <br>- IPAQ questionnaire after 0, 3, 6 and 12 months<br>- Sick days in the period 3 months to 12 months after study inclusion<br>- Blood parameters (CK, LDH, NT-pro BNP, albumin, ferritin, transferrin saturation, calcium, phosphate,) month 0 and 12<br>- PHQ9 Month 0 and 12<br>- ESS Month 0 and 12<br><br>Translated with www.DeepL.com/Translator (free version)