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

NCT06915272 | Completed

• 1 other identifier: 1300
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Mood Disturbances

  Change from baseline to immediately after the 7-day intervention period.

Other Outcomes (1)

• Change in Quality of Life Assessed by the Functional Assessment of Multiple Sclerosis (FAMS) Total Score

  Change from baseline to immediately after the 7-day intervention period.

Study Arms (2)

Cooling Intervention

EXPERIMENTAL

Head and Neck Cooling Intervention

Other: Head and Neck Cooling Intervention

Control

NO INTERVENTION

Interventions

Head and Neck Cooling Intervention 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.

Cooling Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

Greek Multiple Sclerosis Society

Thessaloniki, 55132, Greece

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Antonia Kaltsatou, PhD

  Department of Physical Education and Sport Science, University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor in Clinical Exercise Physiology

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 8, 2025
• Study Start: May 6, 2023
• Primary Completion: May 15, 2023
• Study Completion: May 17, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)