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

February 6, 2021 updated by: Istanbul Physical Medicine Rehabilitation Training and Research Hospital

The Effect of Cognitive Group Exercise Combined With Physical Exercise in Multiple Sclerosis Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34500
        • Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour
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
15 minutes
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.
10-15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Study Chair: Arzu Esmeray, IstanbulPMHTRH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

November 15, 2019

Study Completion (ACTUAL)

December 1, 2019

Study Registration Dates

First Submitted

August 11, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (ACTUAL)

September 3, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulPMRTRH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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