Whole-body Cryotherapy for Fatigue in ME/CFS, Fibromyalgia, Long COVID

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot feasibility study will enroll 40 adults (18–65 years) across four groups: healthy controls and individuals with ME/CFS, fibromyalgia, or Long COVID. Participants will undergo ten cryotherapy sessions over two weeks to assess tolerability, adherence, and the practicality of collecting outcome measures. The study aims to gather initial signals on symptom changes and inform future larger trials. The approach focuses on potential biological mechanisms such as autonomic balance, vascular function, inflammation, and cellular energy processes. No efficacy conclusions will be drawn from this small feasibility cohort.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The study will recruit 40 adult participants (aged 18-65 years) divided across four groups: 10 healthy controls, 10 individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 10 individuals with Fibromyalgia, and 10 individuals with Long COVID.

The relatively small group size is appropriate for a pilot feasibility study, where the primary aim is to assess recruitment, retention, tolerability of the intervention, and the practicality of completing the proposed outcome measures.

The sample size reflects the exploratory nature of the study, current resource availability and funding, and the intensive intervention schedule requiring ten visits over a two-week period. In addition, there is limited UK-based evidence regarding participant responses to whole-body cryotherapy within these clinical populations, further supporting a cautious, feasibility-focused sample size.

Exclusion Criteria:

* The primary physical risks relate to exposure to extreme cold during whole-body cryotherapy and minor discomfort associated with blood sampling. To mitigate these risks, all participants will undergo a structured medical screening using a standard WBCT medical questionnaire to identify contraindications (e.g. uncontrolled hypertension, cardiovascular disease, circulatory disorders such as Raynaud's disease, cryoglobulinaemia, severe respiratory disease, or claustrophobia). Individuals meeting exclusion criteria will not be enrolled.

Where it's running

• Oxford Brookes University - Centre for Movement, Occupation and Rehabilitation Sciences (MOReS)
  Oxford, Oxon, United Kingdom Recruiting

Study contacts

• Study coordinator: Patrick Esser
• Email: pesser@brookes.ac.uk
• Phone: +44 (0) 1865 534881

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.