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

NCT04075968 | Completed

• 1 other identifier: IstanbulPMRTRH
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Neuro-psychometric Test (NPT)

  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

  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)

  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 Outcomes (1)

• Modified Ashworth Scale (MAS)

  3 minutes

Study Arms (2)

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

group 2

control group; patients will be given physical and cognitive home exercise program individually.

Other: Home exercise

Interventions

Cognitive exercise OTHER

Cognitive exercise will be applied

group 1

Home exercise OTHER

Home exercise will be applied

group 2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Istanbul, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Arzu Esmeray

  IstanbulPMHTRH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: September 3, 2019
• Study Start: December 1, 2018
• Primary Completion: November 15, 2019
• Study Completion: December 1, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

TU (1)