Clinical Trials

CEMS: Cooling and exercise in Multiple Sclerosis

Type of Study/Intervention

Interventional

Recruitment Status

Recruiting

Form of MS

Relapsing remitting MS

Brief summary

This study aims to observe the effectiveness of a practical cooling strategy (cold water spray bottle skin cooling) in reducing heat-related fatigue in hot conditions for people with MS. Participants will complete 5 sessions in total:
• 3 practice sessions: Cycling, handgrip & balance sessions in room temperature conditions (1.5hr each).
• 2 experimental sessions: Cycling, handgrip & balance sessions in hot, humid conditions (2.5 hr each). One of these sessions will include the cooling strategy, and one will not.

Inclusion criteria

1) Have clinically or laboratory-supported definite MS (clinically diagnosed MS by a neurologist experienced in the treatment of the disease using updated diagnostic criteria).
2) Have an Expanded Disability Severity score (EDSS) score between 0 (reflecting no disability or decrement to functional systems) and 5 (reflecting the ability to walk without an aid for 200 meters and mild impairment to functional systems).
3) Be between the ages of 18-60 years.
4) Be able to understand the demands of the protocol, have had any questions answered and have voluntarily signed the participant consent form prior to any study procedures.
5) Be in otherwise good health, based on complete medical history and neurological/physical examination (completed Neurologist/General Practitioner Clearance form).
6) Have self-reported sensitivities to the heat.

Exclusion criteria

Participants will be screened via telephone interview to assess their elgibility prior to their participation in the study. Exclusion criteria include:
• Cardiovascular comorbidity (heart disease, hypertension, stroke)
• Abnormal blood disorders (anemia, thrombocytopenia, bleeding diathesis).
• Diabetes.
• Respiratory disease.
• Renal (kidney) disease.
• Hepatic (liver) disease.
• Seizures.
• Peripheral neuropathy.
• Orthopedic concerns that currently affect exercise ability (major surgeries, broken bones, arthritis).
• Active illness (chickenpox, shingles).
• Hypothyroidism.
• Recent major illness.
• Currently taking Tecfidera (a specific MS disease-modifying medication).
• History of taking Lemtrada infusion.

Anticipated start date

March 2022

Recruitment contacts

Dr Nicole Vargas
Postdoctoral Research Associate, Thermal Ergonomics Laboratory, University of Sydney
Email: nicole.vargas@sydney.edu.au
Phone: +61 2 9036 4052

Mr David Hutchinson
Masters Student, Thermal Ergonomics Laboratory, University of Sydeny.
Email: david.hutchinson@sydney.edu.au

Professor Ollie Jay
Director, Thermal Ergonomics Laboratory, University of Sydney
Email: ollie.jay@sydney.edu.au
Phone: +61 2 9351 9323

Further details

Full details of the trial can be found on the ANZCTR clinical trials database (Trial number: ACTRN12618001534279).

Region

NSW

Ethics approval

Yes

Last updated

08/02/2022

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