Multiple Sclerosis (MS) - Relapsing-remittingMS SailingNCT06915272
Effects of Sailing and Cooing in the Quality of Life of Multiple Sclerosis Individuals
A study testing Head and Neck Cooling Intervention in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting
- What is being tested?
- Head and Neck Cooling Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGreece
- Study dates
- 6 May 2023to 17 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Head and Neck Cooling Intervention
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head and Neck Cooling InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cooling Intervention | Experimental | Head and Neck Cooling Intervention Receives: Other: Head and Neck Cooling Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to immediately after the 7-day intervention period.
Secondary outcomes (1)
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.
Measured: Change from baseline to immediately after the 7-day intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start6 May 2023
- Primary completion15 May 2023
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonia Kaltsatou, PhD, University of Thessaly
- Investigators
- Antonia Kaltsatou, PhD, Principal investigator, Department of Physical Education and Sport Science, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06915272
- Sponsor's protocol ID
- 1300
- Acronym
- MS Sailing
- Status last verified
- Apr 2025
- First submitted
- 17 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Head and Neck Cooling on Environmental Symptom Management and Mood in People With Multiple Sclerosis During Sailing
- ClinicalTrials.gov ID
- NCT06915272
- Acronym / sponsor ID
- MS Sailing / 1300
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling Intervention | Experimental | Other: Head and Neck Cooling InterventionHead and Neck Cooling Intervention |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head and Neck Cooling InterventionParticipants 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. | Other | Cooling Intervention |
Primary outcome
Change in MS-related symptoms and heat sensitivity (as measured by Environmental Symptoms Questionnaire - ESQ-IV)
Time frame: Change from baseline to immediately after the 7-day intervention period.
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.
1 secondary outcome
Change in Mood Disturbances
Time frame: Change from baseline to immediately after the 7-day intervention period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Kaltsatou, PhD principal investigator
Department of Physical Education and Sport Science, University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head and Neck Cooling Intervention in people with Multiple Sclerosis (MS) - Relapsing-remitting, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MS-related symptoms and heat sensitivity (as measured by Environmental Symptoms Questionnaire - ESQ-IV) (time frame: Change from baseline to immediately after the 7-day intervention period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.