Clinical trial NCT06248281: Be Cool: An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals
Official title: Be Cool: An Innovative and Holistic Psychoeducational Program to Improve and Promote Care, Education and Quality of Life for Multiple Sclerosis Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: symptom management
hybrid program
rehabilitation
quality of life
psychoeducational program
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Greek Multiple Sclerosis Society
name: European Committee for Treatment and Research in Multiple Sclerosis
First posted: 2024-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from the GMSS (https://gmss.gr/) based on specific inclusion and exclusion criteria.

Brief summary: 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.

Detailed description: Fifteen individuals with multiple sclerosis will participate in an innovative, hybrid rehabilitation program, encompassing several key components to enhance their well-being. The program includes:

1. Exercise Intervention: Participants will engage in specially designed exercise programs. Every two weeks, they will meet virtually with an exercise physiologist via Microsoft Teams for tailored education about their specific needs. Additionally, a customized exercise video will be uploaded weekly to the Teams platform, ensuring ongoing physical engagement.
2. Nutritional Evaluation and Education: Nutrition is a core focus. A nutritionist will meet with the participants bi-weekly to discuss their dietary needs and educate them on maintaining a balanced diet to support their condition. Further enhancing this aspect, a nutritious recipe will be uploaded to the platform each week, offering practical dietary guidance.
3. Psychological Support: Psychological well-being is addressed through weekly group meetings conducted by a psychologist. These sessions will utilize Acceptance and Commitment Therapy (ACT) strategies to help participants manage their symptoms, accept their condition, and improve their overall quality of life.
4. Head and Neck Cooling Strategy: Recognizing the importance of temperature regulation in MS, participants will be advised to apply a cooling strategy to the head and neck area for at least two hours daily, providing symptomatic relief.

To monitor progress and adjust the program as needed, participants' functional ability, nutritional status, psychological condition, and overall quality of life will be evaluated at three key points: baseline (before starting the program), at the three-month mark, and upon completion of the program at six months.

This program is structured to provide a holistic, supportive, and adaptable approach to managing multiple sclerosis, focusing on physical health, nutritional balance, psychological support, and practical strategies for daily living.

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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Primary outcomes:
measure: anxiety and depression
timeFrame: Baseline, after three months and at the end of the six months
measure: Overall quality of life, namely satisfaction with their life
timeFrame: Baseline, after three months and at the end of the six months
measure: Perception of stress
timeFrame: Baseline, after three months and at the end of the six months
measure: Cognitive fusion which refers to the degree to which an individual's thoughts and feelings are intertwined with their sense of self, often leading to an inability to separate from, or 'defuse' from, these internal experiences.
timeFrame: Baseline, after three months and at the end of the six months
measure: The value of living
timeFrame: Baseline, after three months and at the end of the six months
measure: Psychological flexibility which is the ability to be in the present moment with full awareness and openness to experiences, and to take action guided by one's values.
timeFrame: Baseline, after three months and at the end of the six months
measure: The resilience which is defined as the ability to cope with and bounce back from adversity.
timeFrame: Baseline, after three months and at the end of the six months
measure: Aerobic capacity and ability to walk
timeFrame: Baseline, after three months and at the end of the six months
measure: Lower body strength and functional mobility
timeFrame: Baseline, after three months and at the end of the six months
measure: Static and dynamic balance ability
timeFrame: Baseline, after three months and at the end of the six months
measure: Mobility and walking speed
timeFrame: Baseline, after three months and at the end of the six months
Secondary outcomes:
measure: Finger dexterity and arm-hand coordination
timeFrame: Baseline, after three months and at the end of the six months
measure: Core temperature
timeFrame: Baseline, after three months and at the end of the six months
measure: Skin temperature
timeFrame: Baseline, after three months and at the end of the six months
measure: Nutritional status, how balance is their nutrition
timeFrame: Baseline, after three months and at the end of the six months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Greek Multiple Sclerosis Society
state: Central Macedonia
Study officials:
affiliation: Greek Multiple Sclerosis Society
name: Anastasios Orologas, MD, PhD
role: STUDY_CHAIR
References:
citation: Kaltsatou A, Flouris AD. Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review. Mult Scler Relat Disord. 2019 Jan;27:419-423. doi: 10.1016/j.msard.2018.11.013. Epub 2018 Nov 13.