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

NCT ID: NCT06915272

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-06
• Study Completion Date: 2023-05-17

Brief Summary

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.

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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cooling Intervention

Head and Neck Cooling Intervention

Group Type: EXPERIMENTAL

Head and Neck Cooling Intervention

Intervention Type: OTHER

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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion 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

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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• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Antonia Kaltsatou, PhD

Adjunct Assistant Professor in Clinical Exercise Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonia Kaltsatou, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Education and Sport Science, University of Thessaly

Locations

Greek Multiple Sclerosis Society

Thessaloniki, , Greece

Countries

Greece

Other Identifiers

1300

Identifier Type: -

Identifier Source: org_study_id