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NCT04378634: EPIME
Epigenetics of Post-exertional Malaise in Patients With ME/CFS
NA trial testing Exercise in Fatigue Syndrome, Chronic in 105 participants. Completed in 30 April 2023.
30 April 2023
Quick facts
| Lead sponsor | Vrije Universiteit Brussel |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 105 |
| Start date | 1 April 2021 |
| Primary completion | 30 April 2023 |
| Estimated completion | 30 April 2023 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Exercise
- Mental Stress Test
Conditions studied
- Fatigue Syndrome, Chronic — all drugs for Fatigue Syndrome, Chronic →
Sponsor
Vrije Universiteit Brussel — full company profile →
Who can join
Adults 18 to 70, female only, with Fatigue Syndrome, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Exploring epigenetic mechanisms of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) is crucial to understand the mechanisms underlying its pathophysiology. Three potential candidates have been selected (BDNF, COMT, and HDAC genes). DNA methylation in the promoter regions of those genes will be explored. The investigators designed a randomised controlled trial and will enrol 70 patients with ME/CFS and 35 age-, sex-, and BMI-matched healthy controls. Both groups will be randomised in 2 groups and receive either one session of aerobic exercise or a validated test designed to trigger mental stress and mental fatigue. The primary aim is to assess genetic and epigenetic mechanisms of BDNF, COMT and HDAC genes in response to exercise and the stress task.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04378634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Exercise
Trials testing the same drug.
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- NCT06627569 — Exercise Effects on the Neurobiology Underlying Stress-related Eating Behaviors in Veterans · NA · not yet recruiting
Other recruiting trials for Fatigue Syndrome, Chronic
Currently open trials in the same condition.
- NCT07491315 — Is Post-exertional Symptom Exacerbation Specific to Patients With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome? · NA · recruiting
- NCT06472622 — Functional Neuroimaging to Detect the Neural Signatures of the Unpleasantness of Pain and Effort · EARLY_PHASE1 · recruiting
- NCT06775262 — Chronic Fatigue in the Internal Medicine Outpatient Clinic: a Mixed-methods Quantitative and Qualitative Study · recruiting
- NCT05899595 — Effects of a Personalized Physical Training to Reduce Fatigue · NA · recruiting
- NCT03773003 — Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME) · NA · recruiting
Other Vrije Universiteit Brussel trials
Trials by the same sponsor.
- NCT07460778 — Development of Serious Games for Rehabilitation: a Delphi Study · NA · recruiting
- NCT07359521 — Implementation and Evaluation of a Complex Intervention to Reduce Avoidable Transitions Between Nursing Home and Hospita · NA · not yet recruiting
- NCT07356336 — Cognitive Model for Behavioral Interventions as a Non-pharmacological Intervention for Behavioral and Psychological Symp · NA · recruiting
- NCT07212829 — The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With Chronic Widespread Pai · NA · not yet recruiting
- NCT07294131 — Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electro · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04378634 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vrije Universiteit Brussel
- Last refreshed: 7 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04378634.
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