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Be Cool: An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals
Be Cool: An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals

NCT06248281

CompletedN/A

Sponsor: University of Thessaly

Conditions: Multiple Sclerosis

Interventions: combination of different rehabilitation strategies

Countries: Greece

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.

Eligibility overview

Sex: ALL

Age: 19 Years to 65 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Participants must have been diagnosed with MS using the McDonald criteria, ensuring a standardized and validated diagnostic approach.
2. Participants should have been relapse-free during the six months leading up to the study to avoid potential confounding factors.
3. Participants must have no musculoskeletal impediment that could affect their ability to engage in the exercise component of the program.
4. 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.
5. 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.
6. 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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Exclusion Criteria:

1. Previously diagnosed conditions known to impact physiological responses to heat exposure, including diabetes mellitus, hypertension, heart disease, or kidney disease.
2. Use of medications to manage MS-related symptoms, such as antidepressants, psychostimulants, anticonvulsants, antispasmodics, and anticholinergic drugs.

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Locations (1)
  • Thessaloniki, Central Macedonia, Greece