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Multiple SclerosisNCT03591809

Combined Exercise Training in Patients With Multiple Sclerosis

A study testing combined exercise training in people with Multiple Sclerosis, run by Gazi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

It is stated that the affected cognitive functions in Multiple Sclerosis are learning, memory, attention, speed of information processing, visuospatial skills, and executive functions. The speed of information processing, visual learning and memory are the most frequently affected components in MS. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
combined exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteTurkey (Türkiye)
Study dates
3 Sep 2018to 21 Oct 2019
Phase
Interventional
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory
  • Stable phase of the disease without relapses in the last 3 month
  • EDSS between 2-5,5.

Who cannot join

  • Orthopedic, vision, hearing, or perception problems
  • Any cardiovascular or pulmonary disease in which exercise is contraindicated

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Gazi University

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Combined Exercise Training on Cognitive Functions in Patients With Multiple Sclerosis

It is stated that the affected cognitive functions in Multiple Sclerosis are learning, memory, attention, speed of information processing, visuospatial skills, and executive functions. The speed of information processing, visual learning and memory are the most frequently affected components in MS. For this reason, approaches to increase cognitive functions by activating neuroprotective mechanisms such as exercise in patients with MS are needed.

The purpose of this study is to examine the effect of combined exercise training on cognitive functions in patients with MS.

Read the detailed description

The study was designed as a randomized, controlled, single-blind trial. This study will include patients with MS who 0-5.5 according to the Extended Disability Status Scale (EDSS) and between 18-65 years. The patient will be randomized into a combined training group and a control group. The patients in the control group will not apply an exercise training. The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks. Both groups will be reevaluated 8 weeks after the initial assessment.

Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago, IL, USA). The pre-training and post-training measurements of groups will be compared with the Wilcoxon Test. The significance level was set at p< 0.05.

Being tested
combined exercise training
Keywords
cognitive function, fatigue, quality of life, Functional exercise capacity
Medical subject headings
Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • combined exercise trainingOther

    The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.

Study groups in NCT03591809
Study groupRoleWhat they receive
combined exercise training groupExperimentalThe combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.
Receives: Other: combined exercise training
Control groupNo interventionThe patients in the control group will not apply an exercise training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognitive function

    The Brief Repeatable Battery of Neuropsychological Tests

    Measured: Thirty minutes]

Secondary outcomes (3)

  1. functional exercise capacity

    The Six-Minute Walking Test (6MWT) was performed to determine functional exercise capacity

    Measured: ten minutes

  2. Fatigue

    Fatigue impact scale will be used to asses fatigue. There are 40 items, each of which is scored 0 (no problem) to 4 (extreme problem), providing a continuous scale of 0-160. It is composed of three subscales that describe how fatigue impacts upon cognitive (10 items), physical (10 items) and psychosocial functioning (10 items). Cognitive functioning concerns concentration, memory, thinking and organization of thoughts. Physical functioning reflects motivation, effort, stamina and coordination. Psychosocial functioning describes the impact of fatigue upon isolation, emotions, workload and coping.A higher score indicates a higher fatigue impact.

    Measured: five minutes

  3. Multiple Sclerosis Quality of Life-54

    The questionnaire consists of 54 questions with 12 sub-sections; physical function, health perceptions, energy/fatigue, role limitations-physical, pain, sexual function, social function, health distress, the overall quality of life, emotional well-being, role limitations-emotional, cognitive function. The summary scores are the physical health composite summary and the mental health composite summary. There is no single overall score for the MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores. In this scale, the scoring of each question is different from each other and a higher score indicates a lower quality of life.

    Measured: ten minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2018
  2. Study start3 Sep 2018
  3. Primary completion18 Oct 2019
  4. Study completion21 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, controlled, single-blind trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03591809
Sponsor's protocol ID
400
Status last verified
Oct 2019
First submitted
9 Jul 2018
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rao SM, Leo GJ, Bernardin L, Unverzagt F. Cognitive dysfunction in multiple sclerosis. I. Frequency, patterns, and prediction. Neurology. 1991 May;41(5):685-91. doi: 10.1212/wnl.41.5.685.

    PubMed 2027484

  • Rogers JM, Panegyres PK. Cognitive impairment in multiple sclerosis: evidence-based analysis and recommendations. J Clin Neurosci. 2007 Oct;14(10):919-27. doi: 10.1016/j.jocn.2007.02.006. Epub 2007 Jul 30.

    PubMed 17659875

  • Janculjak D, Mubrin Z, Brinar V, Spilich G. Changes of attention and memory in a group of patients with multiple sclerosis. Clin Neurol Neurosurg. 2002 Jul;104(3):221-7. doi: 10.1016/s0303-8467(02)00042-2. No abstract available.

    PubMed 12127658

  • Rosti-Otajarvi EM, Hamalainen PI. Neuropsychological rehabilitation for multiple sclerosis. Cochrane Database Syst Rev. 2014 Feb 11;2014(2):CD009131. doi: 10.1002/14651858.CD009131.pub3.

    PubMed 24515630

  • Cotman CW, Berchtold NC, Christie LA. Exercise builds brain health: key roles of growth factor cascades and inflammation. Trends Neurosci. 2007 Sep;30(9):464-72. doi: 10.1016/j.tins.2007.06.011. Epub 2007 Aug 31.

    PubMed 17765329

  • Smith PJ, Blumenthal JA, Hoffman BM, Cooper H, Strauman TA, Welsh-Bohmer K, Browndyke JN, Sherwood A. Aerobic exercise and neurocognitive performance: a meta-analytic review of randomized controlled trials. Psychosom Med. 2010 Apr;72(3):239-52. doi: 10.1097/PSY.0b013e3181d14633. Epub 2010 Mar 11.

    PubMed 20223924

  • Sangelaji B, Estebsari F, Nabavi SM, Jamshidi E, Morsali D, Dastoorpoor M. The effect of exercise therapy on cognitive functions in multiple sclerosis patients: A pilot study. Med J Islam Repub Iran. 2015 Apr 22;29:205. eCollection 2015.

    PubMed 26157723

  • Romberg A, Virtanen A, Ruutiainen J. Long-term exercise improves functional impairment but not quality of life in multiple sclerosis. J Neurol. 2005 Jul;252(7):839-45. doi: 10.1007/s00415-005-0759-2. Epub 2005 Mar 16.

    PubMed 15765197

Questions about this trial

What is this clinical trial studying?

A study testing combined exercise training in people with Multiple Sclerosis, run by Gazi University 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 3 inclusion and 2 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 22 Oct 2019. 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?

cognitive function (time frame: Thirty minutes]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03591809, which also lists 8 linked publications.

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 22 Oct 2019.

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Clinical Trial NCT03591809 | AzTrials