Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248281
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-12-18
Brief Title:
Be Cool An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals
Sponsor:
University of Thessaly
Organization:
University of Thessaly
Study Overview
Official Title:
Be Cool An Innovative and Holistic Psychoeducational Program to Improve and Promote Care Education and Quality of Life for Multiple Sclerosis Individuals
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BeCool
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None