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

NCT03222596 | Completed

• 1 other identifier: 602-01/17-01-147
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Fatigue; Mental Status Change; Physical Disability; Physical Activity; Mental Impairment; Quality of Life; Disabilities Psychological; Disability Physical; Pain; Energy Supply; Deficiency; Motivation

Keywords

Quality of Life; Fatigue; Physical Disability; Disabilities Psychological; Pain; Motivation; Multiple sclerosis

Outcome Measures

Primary Outcomes (7)

• Change of fatigue intensity

  Fatigue estimation using the "Modified Fatigue Impact Scale" (MFIS)

  baseline, after 4 weeks

• Change of pain intensity

  Assessment of pain level using a "Visual Analogue Scale" (VAS) for pain

  baseline, after 4 weeks

• Motivation.

  Survey made from questions for subjective self-evaluation of motivation efficiency.

  baseline, after 4 weeks

• Change of physical abilities and limitations.

  Assessment of the functional independence of daily activities and severity of individuals disability using the "Barthell Index".

  baseline, after 4 weeks

• Change of mental abilities and limitations.

  Assessment of cognitive ability using the "Standardized Mini-Mental State Examination" test (SMMSE).

  baseline

• Change of 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, after 4 weeks.

• Change of grip strength.

  Grip strength testing using hand hydraulic dynamometer.

  baseline, after 4 weeks

Study Arms (2)

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).

Interventions

Exercise training BEHAVIORAL

Exercise programme includes breathing and upper limbs exercises.

Multiple Sclerosis Exercise

Eligibility Criteria

• Age: 21 Years - 70 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)

Department of physiology and immunology, Medical Faculty, University of Rijeka

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Motor Activity; Pain

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

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

Study Officials

• Tanja Grubić Kezele, PhD, MD

  Biomedicine investigations

  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: PhD, MD

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 19, 2017
• Study Start: July 14, 2017
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

CR (1)