Effects of Sailing and Cooing in the Quality of Life of Multiple Scler
Effects of Head and Neck Cooling on Environmental Symptom Management and Mood in People With Multiple Sclerosis During Sailing
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Head and Neck Cooling Intervention
What it measured
Main measures
Change in MS-related symptoms and heat sensitivity (as measured by Environmental Symptoms Questionnaire - ESQ-IV)
Change from baseline to immediately after the 7-day intervention period.
Other measures (1)
Change in Mood Disturbances
Change from baseline to immediately after the 7-day intervention period.
FatigueMood and sleep
Who could take part
Relapsing MS · EDSS 0 to 5.5
Show the full criteria
Inclusion criteria
Inclusion Criteria: Were adults aged 18 years or older. Had a confirmed diagnosis of relapsing-remitting multiple sclerosis (RRMS) based on the 2017 McDonald criteria. Had experienced no relapse within the past six months. Had an Expanded Disability Status Scale (EDSS) score between 0 and 5.5, indicating the ability to walk at least 100 meters independently without assistance. Had a documented history of heat sensitivity confirmed by their physician. Had not used any cooling therapy within at least four months prior to study participation. Were fluent in English (for accurate completion of questionnaires and instructions). Exclusion Criteria: Used medications specifically prescribed to manage psychological MS-related symptoms (e.g., antidepressants, psychostimulants). Had experienced an MS relapse within the past six months. Had an Expanded Disability Status Scale (EDSS) score greater than 5.5 (unable to walk at least 100 meters independently). Had no documented history of heat sensitivity related to MS. Had used any cooling therapies within four months prior to the study participation. Were unable to understand or communicate fluently in English. -
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
In this study, we aim to evaluate the impact of head and neck cooling on symptoms and psychological states in individuals with Multiple Sclerosis (MS) during a 7-day Oceans of Hope Challenge sailing trip around the Greek islands of the Argosaronic Gulf in May 2023. Forty-five individuals with relapsing-remitting MS will participate in the sailing trip. Participants will be allocated to either a Cooling group (n=25), using a cooling cap and neck towel for at least two hours per day, or a Control group (n=20) without cooling interventions. Before and after the trip, participants will complete the Functional Assessment of Multiple Sclerosis Scale (FAMS), the Environmental Symptoms Questionnaire (ESQ), and the abbreviated 40-item Profile of Mood States (POMS-40). These assessments will be used to evaluate quality of life, environmental symptoms, and mood states. The study is designed to examine whether daily use of head and neck cooling during a prolonged outdoor activity influences MS-related symptoms, quality of life, and psychological well-being.
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History
Started
May 2023
Main results due
May 2023
Finished
May 2023