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Impact of Exercise on "Invisible" Symptoms and Quality of Life in Multiple Sclerosis Individuals

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ClinicalTrials.gov Identifier: NCT03768830
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Tanja Grubic Kezele, University of Rijeka

Brief Summary:

Patients with multiple sclerosis (MS) struggle on a daily basis with accompanying, "Invisible" symptoms like primary fatigue, pain and emotional-cognitive disorders. With the disease progression, these symptoms only intensify, and in combination with basic physical symptoms, quality of life (QOL) rapidly decreases.

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 these "Invisible" symptoms, thus improving 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 program exercise, and can hardly keep continuum including endurance exercise, or treadmill.

Hypothesis:

Investigators hypothesis is that 8-weeks of continuous low demanding or mild exercise program with the accent on breathing exercise can attenuate primary fatigue, pain, headaches, emotional-cognitive and sleep dysfunctions in MS patients 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 Quality of Life Motivation Pain Headache Migraine Anxiety Disorders Depressive Disorder Sleep Disorder Insomnia Physical Disability Fatigue Behavioral: Exercise training Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomly selected into 4 groups: MS individuals that will exercise - group (MSE), with related control group of individuals who will not exercise) (MSC).

In addition, a group of healthy control subjects without MS (HE) will also exercise and be evaluated after the study with related control individuals who will not exercise (HC).

Group of MS and healthy individuals will exercise under the guidance of a physiotherapist.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of 8-weeks Mild Exercise Training on "Invisible" Symptoms and Quality of Life in Ambulatory and Non-ambulatory (EDSS From 0.0 - 8.0) Individuals With Multiple Sclerosis: a Randomized Controlled Trial
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : February 5, 2019
Actual Study Completion Date : February 5, 2019

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 program includes breathing and upper and lower limbs exercise.

No Intervention: Multiple Sclerosis Control (no-Exercise)
Ambulatory and non-ambulatory MS individuals that will not exercise-group (MSC).
Experimental: Healthy Exercise
Healthy individuals that will exercise-group (HE). Intervention is exercise training.
Behavioral: Exercise training
Exercise program includes breathing and upper and lower limbs exercise.

No Intervention: Healthy Control (no-Exercise)
Healthy individuals that will not exercise (HC).



Primary Outcome Measures :
  1. Change of fatigue intensity [ Time Frame: baseline, up to 8 weeks ]
    Fatigue estimation using the "Modified Fatigue Impact Scale" (MFIS) questionnaire. This test gives an assessment of tiredness effects on physical, cognitive and psychosocial functioning and can therefore be treated as 3 separate categories. In full-time MFIS consists of 21 questions. The time to complete is 5-10 minutes and the examinee can solve the test without the help of an interviewer. The total points are obtained by summing all the answers or the additions are made separately by the mentioned categories.

  2. Change of pain intensity [ Time Frame: baseline, up to 8 weeks ]
    Assessment of pain level using a "Visual Analogue Scale" (VAS) for pain. It is a psychometric response scale or a measurement instrument for subjective characteristics that cannot be directly measured. Here, the participants state their degree of agreement with the facial expression shown with the description of the pain in words, including the appropriate number below the image. The VAS for pain is 5 units long, 0 to 5 (0-no pain and 5-hardest possible pain).

  3. Change in quality of life [ Time Frame: baseline, up to 8 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.

  4. Change in sleeping quality - ISI [ Time Frame: baseline, up to 8 weeks ]
    Evaluation of sleeping quality using ISI questionnaire. The test is designed to assess the nature, severity, and impact of insomnia and it consists of 7 items: Severity of sleep onset, sleep maintenance and early morning wakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, notice ability of sleep problems by others, distress caused by the sleep difficulties.

  5. Change in sleeping quality - PSQI [ Time Frame: baseline, up to 8 weeks ]
    Evaluation of sleeping quality using PSQI questionnaire. The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring 7 areas (components): subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.

  6. Change in psychological symptoms [ Time Frame: baseline, up to 8 weeks ]
    The CORE-OM has 34 items, all with the same five level response choice, and covers the last seven days. It was designed, and this was led partly by the commissioning specification, to cover four main domains: wellbeing, problems, functioning and risk and has 4, 12, 12 and 6 items focused on those domains respectively. The original scoring was the mean across the items, i.e. between 0 and 4 as the scoring of the item responses is from 0 to 4, more recently, to require fewer decimal places, scores have often been reported after multiplying that by ten. Caution should be used to make sure whether results are reported with that x10 multiplier though it is rarely likely that results can be confused as to scoring.

  7. Change in Headache-Migraine intensity and frequency [ Time Frame: baseline, up to 8 weeks ]
    Survey Survey made from questions for subjective self-evaluation of Headache-Migraine intensity and frequency.


Secondary Outcome Measures :
  1. Motivation evaluation [ Time Frame: up 8 weeks ]
    Survey made from questions for subjective self-evaluation of motivation efficiency.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 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): NCT03768830


Locations
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Croatia
University of Rijeka, Faculty of Medicine, Department of Physiology, Immunology and Pathophysiology
Rijeka, Croatia, 51000
Sponsors and Collaborators
University of Rijeka
Investigators
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Principal Investigator: Tanja Grubić Kezele, PhD, MD University of Rijeka

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Responsible Party: Tanja Grubic Kezele, Principal Investigator, University of Rijeka
ClinicalTrials.gov Identifier: NCT03768830     History of Changes
Other Study ID Numbers: 003-08/18-01/05
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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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
Multiple Sclerosis
Pain
Headache
Anxiety Disorders
Depressive Disorder
Sleep Disorder
Fatigue

Additional relevant MeSH terms:
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Disease
Sclerosis
Multiple Sclerosis
Depressive Disorder
Depression
Fatigue
Headache
Anxiety Disorders
Sleep Wake Disorders
Parasomnias
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Mood Disorders
Mental Disorders
Behavioral Symptoms
Signs and Symptoms
Pain
Neurologic Manifestations