Effect of Cooling Vest in Multiple Sclerosis Patients

NCT ID: NCT07064239

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-20
• Study Completion Date: 2025-07-08

Brief Summary

This study is prospective, randomized controlled trail that will be conducted to investigate the effect of cooling therapy on fatigue and gait in patient with multiple sclerosis(MS).

Detailed Description

Thirty patients from both sexes will be enrolled in this study. They will be assigned into two equal groups (study and control groups). Patients will be diagnosed as MS patients based on careful clinical evaluation by the neurologist and magnetic resonance imaging (MRI) of the brain. The patients will be recruited from the faculty of Physical Therapy, Cairo University, and El Kasr El Ainy hospitals.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A placebo group

include A 15 individuals with relapsing-remitting MS performed 30 minutes of aerobic exercise (upper- and lower-extremity ergometry and treadmill ambulation) without wearing cooling vest, followed by unstructured physical activity. 15 participants completed the intervention and posttest follow-up. quality of life (measured with the Multiple Sclerosis Quality of Life-54; MSQOL-54) were assessed. Participants completed 27.9 minutes of exercise per session, session will done for three sessions of aerobic exercise and Frenkel Coordination Exercises per week for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Aerobic exercises

Intervention Type: OTHER

aerobic exercise as any activity that uses large muscle groups, can be maintained continuously and is rhythmic in nature. As the name implies, muscle groups activated by this type of exercise rely on aerobic metabolism to extract energy in the form of adenosine triphosphate (ATP) from amino acids, carbohydrates and fatty acids. Examples of aerobic exercise include cycling, dancing, hiking, jogging/long distance running, swimming and walking

Group B cooling vest group

include A 15 individuals with relapsing-remitting MS performed 30 minutes of aerobic exercise (upper- and lower-extremity ergometry and treadmill ambulation) with wearing cooling vest, followed by unstructured physical activity. Eight participants completed the intervention and posttest follow-up. quality of life (measured with the Multiple Sclerosis Quality of Life-54; MSQOL-54) were assessed. Participants completed 27.9 minutes of exercise per session, session will done for three sessions of aerobic exercise and Frenkel Coordination Exercises per week for 6 weeks.

Group Type: EXPERIMENTAL

cooling vest

Intervention Type: DEVICE

Cooling vest :

It is one of cooling methods proposed to improve exercise performance in MS by reducing one's core and/or skin temperature before taking on physical work

Aerobic exercises

Intervention Type: OTHER

aerobic exercise as any activity that uses large muscle groups, can be maintained continuously and is rhythmic in nature. As the name implies, muscle groups activated by this type of exercise rely on aerobic metabolism to extract energy in the form of adenosine triphosphate (ATP) from amino acids, carbohydrates and fatty acids. Examples of aerobic exercise include cycling, dancing, hiking, jogging/long distance running, swimming and walking

Interventions

cooling vest

Cooling vest :

It is one of cooling methods proposed to improve exercise performance in MS by reducing one's core and/or skin temperature before taking on physical work

Intervention Type: DEVICE

Aerobic exercises

aerobic exercise as any activity that uses large muscle groups, can be maintained continuously and is rhythmic in nature. As the name implies, muscle groups activated by this type of exercise rely on aerobic metabolism to extract energy in the form of adenosine triphosphate (ATP) from amino acids, carbohydrates and fatty acids. Examples of aerobic exercise include cycling, dancing, hiking, jogging/long distance running, swimming and walking

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Thirty MS patients of both sexes.
• Age of patients ranges from 20 to 40 years.
• NOT less than 8 months since Symptoms onset.
• The body mass index ranged (BMI) from 20 - 24.5 Kg/m2 .
• The grade of The muscle tone of the affected limbs muscles ranged from 1
• to 2 grade according to Modified Ashower scale of muscle tone
• All the patients are medically stable.
• Patients have intact sensations (deep & superficial).

Exclusion Criteria

• Other neurological and orthopedic impairments in upper or lower limb.
• Having visual and hearing problems.
• Inability to sit independently on a chair.
• Impaired cognition and impaired comprehension and ideomotor apraxia.
• History of endogenous depression or severe psychiatric disorders.
• Severe neglect, and major medical problems or comorbidities that will influence upper or lower extremity usage or cause severe pain.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mina Khalil essa ibrahim

Demonstrator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

P.T.Rec/012/005788

Identifier Type: -

Identifier Source: org_study_id