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The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075968
Recruitment Status : Completed
First Posted : September 3, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Brief Summary:
The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis. We assume that cognitive therapy is an effective treatment for multiple sclerosis.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Cognitive exercise Other: Home exercise

Detailed Description:
The aim of this study is to investigate the effect of cognitive rehabilitation in group with physical exercise in patients with Multiple Sclerosis.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Cognitive Group Exercise Combined With Physical Exercise in Multiple Sclerosis Patients
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
group 1
exercise group; 6 weeks, twice a week, 30 minutes physical group exercises and 30 minutes general cognitive function exercises will be applied as groups.
Other: Cognitive exercise
Cognitive exercise will be applied

group 2
control group; patients will be given physical and cognitive home exercise program individually.
Other: Home exercise
Home exercise will be applied




Primary Outcome Measures :
  1. Neuro-psychometric Test (NPT) [ Time Frame: 1 hour ]
    It is a test that evaluates memory, working memory, planning, organization, attendance span.Evaluation is made according to the number of items filled. The higher number items filled indicates the better status

  2. Berg Balance Scale [ Time Frame: 15 minutes ]
    It is a scale which consists of 14 items. Each item is scored on a five-point scale (0-4).The maximum score for this assessment is 56 and the minimum score for this assessment is 0. Scores below 45 indicate balance impairment. The higher point indicates the better status

  3. Mini Mental State Test (MMST) [ Time Frame: 10-15 minutes ]
    It is a test that evaluates different subset of cognitive status including attention, memory, language, orientation, visuospatial proficiency. It is scored on a scale of 0-30 with scores. Scores above 25 are interpreted as normal cognitive status.


Secondary Outcome Measures :
  1. Modified Ashworth Scale (MAS) [ Time Frame: 3 minutes ]
    The MAS is a 6-point rating scale which assesses muscle tone by manually manipulating the joint through its available range of motion and clinically recording the resistance to passive movements. The lower point indicates the better status



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with definitive Multiple Sclerosis between 20-65 years, with an Mini Mental State Test score less than 24, with an Extended Disability Status Scale score less than 4, trained for at least 5 years, have not received steroid therapy in the last 1 month
Criteria

Inclusion Criteria:

  • Patients with an Mini Mental State Test score less than 24
  • Patients with an Extended Disability Status Scale score less than 4
  • Patients trained for at least 5 years
  • Patients who have not received steroid therapy in the last 1 month

Exclusion Criteria:

  • Patients who have not passed at least 3 months from the last Multiple Sclerosis attack
  • Patients with hearing and vision problems that may interfere with communication
  • The patients who Have other neurological and psychiatric disorder that will cause cognitive impairment
  • Patients receiving medical treatment for spasticity, tremor, bladder disorder and fatigue

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075968


Locations
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Turkey
Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Istanbul, Turkey, 34500
Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Study Chair: Arzu Esmeray IstanbulPMHTRH
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Responsible Party: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04075968    
Other Study ID Numbers: IstanbulPMRTRH
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases