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

NCT ID: NCT06248281

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-02-28

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Experimental group

The experimental group will attend a structured psychoeducational program developed to build and promote psychological flexibility. In combination with this, participants of this group will have to follow a head and neck cooling protocol. Also, participants of this group will be required to increase their habitual exercise levels and follow a video exercise program specifically designed for their needs and improve their nutrition based on the instructions of a nutritionist and videos specially designed for them.

combination of different rehabilitation strategies

Intervention Type: OTHER

The psychoeducational program will be conducted through weekly online video-conferencing group sessions that will last for two hours. In addition to these sessions, participants will receive psychoeducational material such as readings, videos, podcasts, worksheets, and homework exercises every week. This material will allow participants to practice at their own pace during the session intervals.

The exercise training program for individuals with MS will be tailored to meet the unique and individual needs of each participant. To achieve this, a head and neck cooling protocol will be implemented using commercially available cooling equipment, specifically the Headcool Power and Neckcool Tie from Inuteq. Participants will need to wear the cooling cup and neck wrap for two hours daily. The equipment will be activated using 10°C tap water. Finally, a nutritionist will provide personalized nutritional guidance including weekly diet observation and recipe videos.

Control group

As per the study plan, the Control group has been designated as the control group. They will continue with their normal lifestyle without any participation in rehabilitation activities or programs.

combination of different rehabilitation strategies

Intervention Type: OTHER

The psychoeducational program will be conducted through weekly online video-conferencing group sessions that will last for two hours. In addition to these sessions, participants will receive psychoeducational material such as readings, videos, podcasts, worksheets, and homework exercises every week. This material will allow participants to practice at their own pace during the session intervals.

The exercise training program for individuals with MS will be tailored to meet the unique and individual needs of each participant. To achieve this, a head and neck cooling protocol will be implemented using commercially available cooling equipment, specifically the Headcool Power and Neckcool Tie from Inuteq. Participants will need to wear the cooling cup and neck wrap for two hours daily. The equipment will be activated using 10°C tap water. Finally, a nutritionist will provide personalized nutritional guidance including weekly diet observation and recipe videos.

Interventions

combination of different rehabilitation strategies

The psychoeducational program will be conducted through weekly online video-conferencing group sessions that will last for two hours. In addition to these sessions, participants will receive psychoeducational material such as readings, videos, podcasts, worksheets, and homework exercises every week. This material will allow participants to practice at their own pace during the session intervals.

The exercise training program for individuals with MS will be tailored to meet the unique and individual needs of each participant. To achieve this, a head and neck cooling protocol will be implemented using commercially available cooling equipment, specifically the Headcool Power and Neckcool Tie from Inuteq. Participants will need to wear the cooling cup and neck wrap for two hours daily. The equipment will be activated using 10°C tap water. Finally, a nutritionist will provide personalized nutritional guidance including weekly diet observation and recipe videos.

Intervention Type: OTHER

Other Intervention Names

cooling therapy; diet; phycology-behavioral-mindfulness intervention; exercise traiining

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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• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Greek Multiple Sclerosis Society

UNKNOWN

Sponsor Role: collaborator

European Committee for Treatment and Research in Multiple Sclerosis

UNKNOWN

Sponsor Role: collaborator

University of Thessaly

OTHER

Sponsor Role: lead

Responsible Party

Antonia Kaltsatou, PhD

Adjunct Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anastasios Orologas, MD, PhD

Role: STUDY_CHAIR

Greek Multiple Sclerosis Society

Locations

Greek Multiple Sclerosis Society

Thessaloniki, Central Macedonia, Greece

Countries

Greece

References

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.

Reference Type: BACKGROUND

PMID: 30544086 (View on PubMed)

Other Identifiers

396/23

Identifier Type: -

Identifier Source: org_study_id