Multiple SclerosisNCT04075968
The Effect of Cognitive Group Exercise Combined With Physical Exercise in MS
An observational study of Multiple Sclerosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Cognitive exercise and Home exercise
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Istanbul, 34500
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Cognitive exercise, Home exercise
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive exerciseOther
Cognitive exercise will be applied
Home exerciseOther
Home exercise will be applied
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cognitive exercise | |
| group 2 | control group; patients will be given physical and cognitive home exercise program individually. Receives: Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 10-15 minutes
Secondary outcomes (1)
Modified Ashworth Scale (MAS)
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
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start1 Dec 2018
- Primary completion15 Nov 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arzu Esmeray, Study chair, IstanbulPMHTRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075968
- Sponsor's protocol ID
- IstanbulPMRTRH
- Status last verified
- Feb 2021
- First submitted
- 11 Aug 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Group Exercise Combined With Physical Exercise in Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT04075968
- Acronym / sponsor ID
- IstanbulPMRTRH
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 15 Nov 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: Cognitive exerciseexercise 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 | – | Other: Home exercisecontrol group; patients will be given physical and cognitive home exercise program individually. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive exerciseCognitive exercise will be applied | Other | group 1 |
| Home exerciseHome exercise will be applied | Other | group 2 |
Primary outcome
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
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
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.
1 secondary outcome
Modified Ashworth Scale (MAS)
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arzu Esmeray study chair
IstanbulPMHTRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuro-psychometric Test (NPT) (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.