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

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Cognitive exercise; Other: Home exercise

• Registration Number: NCT04075968
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-29
• Study First Posted: 2019-09-03
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-06
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group 1	Cognitive exercise	exercise group; 6 weeks, twice a week, 30 minutes physical group exercises and 30 minutes general cognitive function exercises will be applied as groups.
group 2	Home exercise	control group; patients will be given physical and cognitive home exercise program individually.

Primary Outcome Measures

Name	Time	Method
Neuro-psychometric Test (NPT)	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
Berg Balance Scale	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
Mini Mental State Test (MMST)	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

Name	Time	Method
Modified Ashworth Scale (MAS)	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

Trial Locations

Locations (1)

Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital; 🇹🇷 Istanbul, Turkey