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

NCT03768830 | Completed

• 1 other identifier: 003-08/18-01/05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Quality of Life; Motivation; Pain; Headache; Migraine; Anxiety Disorders; Depressive Disorder; Sleep Disorder; Insomnia; Physical Disability; Fatigue

Keywords

Quality of life; Multiple Sclerosis; Pain; Headache; Anxiety Disorders; Depressive Disorder; Sleep Disorder; Fatigue

Outcome Measures

Primary Outcomes (7)

• Change of fatigue intensity

  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.

  baseline, up to 8 weeks

• Change of pain intensity

  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).

  baseline, up to 8 weeks

• Change in quality of life

  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.

  baseline, up to 8 weeks

• Change in sleeping quality - ISI

  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.

  baseline, up to 8 weeks

• Change in sleeping quality - PSQI

  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.

  baseline, up to 8 weeks

• Change in psychological symptoms

  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.

  baseline, up to 8 weeks

• Change in Headache-Migraine intensity and frequency

  Survey Survey made from questions for subjective self-evaluation of Headache-Migraine intensity and frequency.

  baseline, up to 8 weeks

Secondary Outcomes (1)

• Motivation evaluation

  up 8 weeks

Study Arms (4)

Multiple Sclerosis Exercise

EXPERIMENTAL

Ambulatory and non-ambulatory MS individuals that will exercise-group (MSE). Intervention is exercise training.

Behavioral: Exercise training

Multiple Sclerosis Control (no-Exercise)

NO INTERVENTION

Ambulatory and non-ambulatory MS individuals that will not exercise-group (MSC).

Healthy Exercise

EXPERIMENTAL

Healthy individuals that will exercise-group (HE). Intervention is exercise training.

Behavioral: Exercise training

Healthy Control (no-Exercise)

NO INTERVENTION

Healthy individuals that will not exercise (HC).

Interventions

Exercise training BEHAVIORAL

Exercise program includes breathing and upper and lower limbs exercise.

Healthy Exercise; Multiple Sclerosis Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rijeka: lead

Study Sites (1)

University of Rijeka, Faculty of Medicine, Department of Physiology, Immunology and Pathophysiology

Rijeka, 51000, Croatia

Location

Related Publications (1)

• Grubic Kezele T, Trope Z, Ahel V, Ruzic N, Omrcen H, Dudaric L, Fuzinac-Smojver A. Upper-lower limb and breathing exercise program for improving sleep quality and psychological status in multiple sclerosis: a pilot randomized controlled trial. Brain Impair. 2023 Mar;24(1):86-102. doi: 10.1017/BrImp.2021.17. Epub 2021 Oct 1.

  PMID: 38167585 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Pain; Headache; Migraine Disorders; Anxiety Disorders; Depressive Disorder; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Mental Disorders; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Tanja Grubić Kezele, PhD, MD

  University of Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: October 1, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 5, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

CR (1)