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The Impact of Exercise Training on Living Quality in Multiple Sclerosis Individuals

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ClinicalTrials.gov Identifier: NCT03222596
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Tanja Grubic Kezele, University of Rijeka

Brief Summary:

The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced sense of fatigue that can have negative effect on functional ability and quality of life (QOL).

An important goal of researchers and clinicians involves improving the QOL of individuals with MS, and the exercise therapy represents potentially modifiable behavior that positively impacts on pathogenesis of MS and thus the QOL.

However, the main barrier for its application is low motivational level that MS patients experience due to fatigue with adjacent reduced exercise tolerability and mobility, and muscle weakness. Getting individuals with MS motivated to engage in continuous physical activity may be particularly difficult and challenging, especially those with severe disability or Expanded Disability Status Scale (EDSS 6-8).

Till now, researchers have focused their attention mainly on the moderate or vigorous intensity of exercise and on cardiorespiratory training in MS patients to achieve improvements in daily life quality, less indicating the exercise content, and most importantly, breathing exercises.

In addition, it is investigators intention to make exercise for MS patients more applicable and accessible, motivational and easier, but most important, productive.

Investigators think that MS patients experience more stress with aerobic exercise or moderate to high intensity programme exercise, and can hardly keep continuum including endurance exercise, or treadmill.

Hypothesis:

Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise programme with specific content and an accent on breathing exercise can attenuate primary fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, and provide maintenance of exercise motivation. Investigators also propose that important assistant factor for final goal achievement is social and mental support of the exercise group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise motivation and finally make better psychophysical functioning, and thus better QOL.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Fatigue Mental Status Change Physical Disability Physical Activity Mental Impairment Quality of Life Disabilities Psychological Disability Physical Pain Energy Supply; Deficiency Motivation Behavioral: Exercise training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomly selected into 2 groups: ambulatory and non-ambulatory (wheelchair) MS individuals that will exercise - group (MSE), with related control group (ambulatory and non-ambulatory (wheelchair) individuals who will not exercise) (MSC). In addition, a group of healthy control subjects without MS (HC) will be evaluated.

Ambulatory and non-ambulatory group of individuals will exercise under the guidance of a physiotherapist.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of 4-weeks Mild Exercise Training on Living Quality in Ambulatory and Non-ambulatory Multiple Sclerosis Individuals (EDSS From 0-8) in Motivational and Social Supporting Environment: a Randomized Controlled Trial
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : August 28, 2017
Actual Study Completion Date : August 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multiple Sclerosis Exercise
Ambulatory and non-ambulatory MS individuals that will exercise-group (MSE). Intervention is exercise training.
Behavioral: Exercise training
Exercise programme includes breathing and upper limbs exercises.

No Intervention: Multiple Sclerosis Control (no-Exercise)
Ambulatory and non-ambulatory MS individuals that will not exercise-group (MSC).



Primary Outcome Measures :
  1. Change of fatigue intensity [ Time Frame: baseline, after 4 weeks ]
    Fatigue estimation using the "Modified Fatigue Impact Scale" (MFIS)

  2. Change of pain intensity [ Time Frame: baseline, after 4 weeks ]
    Assessment of pain level using a "Visual Analogue Scale" (VAS) for pain

  3. Motivation. [ Time Frame: baseline, after 4 weeks ]
    Survey made from questions for subjective self-evaluation of motivation efficiency.

  4. Change of physical abilities and limitations. [ Time Frame: baseline, after 4 weeks ]
    Assessment of the functional independence of daily activities and severity of individuals disability using the "Barthell Index".

  5. Change of mental abilities and limitations. [ Time Frame: baseline ]
    Assessment of cognitive ability using the "Standardized Mini-Mental State Examination" test (SMMSE).

  6. Change of quality of life. [ Time Frame: baseline, after 4 weeks. ]
    Evaluation of Quality of Life using the abbreviated version of the "36-Item Short Form Survey" (36-SF) including physical function, role of constraints due to physical problems, physical pain, general health perception, energy level, social function, the role of limitations due to psychological problems and general mental health.

  7. Change of grip strength. [ Time Frame: baseline, after 4 weeks ]
    Grip strength testing using hand hydraulic dynamometer.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals with multiple sclerosis (EDSS 0-8)
  • Ambulatory and non-ambulatory (in wheelchairs)

Exclusion Criteria:

  • Individuals with contraindications for exercising
  • Individuals with multiple sclerosis with EDSS over 8

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222596


Locations
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Croatia
Department of physiology and immunology, Medical Faculty, University of Rijeka
Rijeka, Primorsko-goranska Županija, Croatia, 51000
Sponsors and Collaborators
University of Rijeka
Investigators
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Principal Investigator: Tanja Grubić Kezele, PhD, MD Biomedicine investigations

Additional Information:
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Responsible Party: Tanja Grubic Kezele, PhD, MD, University of Rijeka
ClinicalTrials.gov Identifier: NCT03222596     History of Changes
Other Study ID Numbers: 602-01/17-01-147
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tanja Grubic Kezele, University of Rijeka:
Quality of Life
Fatigue
Physical Disability
Disabilities Psychological
Pain
Motivation
Multiple sclerosis

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Fatigue
Protein-Energy Malnutrition
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Protein Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders