NCT06248281Completed
Be Cool: An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals
Be Cool: An Innovative and Holistic Psychoeducational Program to Improve and Promote Care, Education and Quality of Life for Multiple Sclerosis Individuals
Source: ClinicalTrials.gov · Last updated 8 May 2024
Brief summary (registry, in English)
This observational study aims to investigate the impact of an online psychoeducational program, combined with cooling therapy, nutrition, psychological intervention, and exercise, on the resilience, treatment adherence, symptom management, and quality of life of individuals with Multiple Sclerosis. The study will last for six months, during which two groups of 15 participants with similar characteristics and a diagnosis of Multiple Sclerosis will take part in the protocol. Group A will follow the research protocol, while Group B, the Control group, will not participate in any rehabilitation intervention.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 18 Dec 2023
- Start date
- 1 Jun 2023
- Primary completion date
- 1 Jul 2023
- Lead sponsor
- University of Thessaly
- Diseases
- Multiple sclerosis
- NCT number
- NCT06248281
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 1 Jun 2023 to the primary completion date, 1 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed conditions known to impact physiological responses to heat exposure, including diabetes mellitus, hypertension, heart disease, or kidney disease.
- Use of medications to manage MS-related symptoms, such as antidepressants, psychostimulants, anticonvulsants, antispasmodics, and anticholinergic drugs.
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Who the study is looking for
- Participants must have been diagnosed with MS using the McDonald criteria, ensuring a standardized and validated diagnostic approach.
- Participants should have been relapse-free during the six months leading up to the study to avoid potential confounding factors.
- Participants must have no musculoskeletal impediment that could affect their ability to engage in the exercise component of the program.
- Participants must have a score on the Expanded Disability Status Scale (EDSS) ranging from 0 to 5.5, indicating ambulatory ability without the need for a cane for at least 100 meters.
- Participants should have a history of sensitivity to heat, as reported by their treating physician, justifying the need for cooling therapy as part of the hybrid program.
- Participants must not have used cooling therapy or participated in any form of exercise training for at least four months prior to their participation in the study.
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Age in the registry: 19 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Greek Multiple Sclerosis Society Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.