Effects of Sailing and Cooing in the Quality of Life of Multiple Sclerosis Individuals (MS Sailing)

Effects of Head and Neck Cooling on Environmental Symptom Management and Mood in People With Multiple Sclerosis During Sailing

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
• Intervention / Treatment: Other: Head and Neck Cooling Intervention

Detailed Description

Multiple sclerosis (MS) is a chronic neurodegenerative disease characterized by physical and cognitive impairments that significantly affect patients' quality of life. Common symptoms include fatigue, mobility limitations, cognitive difficulties, anxiety, depression, and social isolation. Exercise is widely recognized as beneficial for managing MS symptoms; however, participation in structured exercise programs remains low due to barriers such as fear, negative past experiences, or lack of interest.

This study aims to explore whether unstructured outdoor leisure activities, specifically sailing combined with head and neck cooling, can help reduce symptom severity and improve psychological states in individuals with MS. Outdoor leisure activities have demonstrated positive effects on psychological and emotional health by reducing depression, improving mood, and promoting social engagement. Sailing, which combines physical activity and social interaction, may enhance quality of life in people with MS. However, sensitivity to increases in body temperature is a known challenge for individuals with MS, as it can exacerbate symptoms and deter physical activity participation. Cooling strategies, such as head and neck cooling, have been used to help maintain thermal comfort and support symptom management.

The objective of this study is to assess the impact of daily head and neck cooling on MS symptoms and psychological well-being during a 7-day sailing trip (Oceans of Hope Challenge) in the Argosaronic Islands, Greece. Ethical approval was obtained from the Greek Multiple Sclerosis Society.

A total of 45 participants with relapsing-remitting MS will be randomly assigned to either a Cooling group or a Control group. The Cooling group will use head and neck cooling devices daily for a minimum of two hours during the sailing trip, while the Control group will participate without cooling interventions. Both groups will engage in daily sailing activities, navigation tasks, and island exploration.

Participants will complete three questionnaires before and after the trip: the Functional Assessment of MS Scale (FAMS) to assess quality of life, the Environmental Symptoms Questionnaire (ESQ-IV) to evaluate general well-being and symptom severity, and the Profile of Mood States (POMS-40) to assess mood states.

Statistical analyses will include two-way repeated measures ANOVA and independent t-tests to evaluate within- and between-group differences over time. The study is designed to determine whether integrating cooling strategies into outdoor leisure activities can reduce MS symptom severity, improve psychological well-being, and potentially encourage greater participation in therapeutic recreational activities.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 55132
    • Greek Multiple Sclerosis Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Cooling Intervention; Head and Neck Cooling Intervention	Other: Head and Neck Cooling Intervention; Participants received a head and neck cooling intervention involving the daily use (≥2 hours/day) of cooling devices consisting of a cooling cap and cooling towel specifically designed for localized head and neck cooling. Devices were activated by immersing them in cold water maintained at approximately 10°C.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in MS-related symptoms and heat sensitivity (as measured by Environmental Symptoms Questionnaire - ESQ-IV)	Evaluated by comparing total symptom scores before and after the 7-day sailing intervention between the cooling group and the control group. This outcome directly assesses the effectiveness of the head and neck cooling intervention in managing MS symptoms exacerbated by heat stress.	Change from baseline to immediately after the 7-day intervention period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mood Disturbances	The Profile of Mood States (POMS-40) will be used to assess mood disturbances across several dimensions, including tension, depression, confusion, anger, vigor, and fatigue.	Change from baseline to immediately after the 7-day intervention period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life Assessed by the Functional Assessment of Multiple Sclerosis (FAMS) Total Score	The Functional Assessment of MS Scale (FAMS) will be used to assess quality of life across the following domains: mobility, MS-related symptoms, emotional well-being, general contentment, thinking/fatigue, and family/social well-being.	Change from baseline to immediately after the 7-day intervention period.

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Principal Investigator: Antonia Kaltsatou, PhD, Department of Physical Education and Sport Science, University of Thessaly

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2023
• Primary Completion (Actual): May 15, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 1300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy, as the informed consent obtained did not include provisions for data sharing with third-party researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No