Pain Clinical Trial
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
Verified date | December 2018 |
Source | University of Rijeka |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 28, 2017 |
Est. primary completion date | August 28, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Department of physiology and immunology, Medical Faculty, University of Rijeka | Rijeka | Primorsko-goranska Županija |
Lead Sponsor | Collaborator |
---|---|
University of Rijeka |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of fatigue intensity | Fatigue estimation using the "Modified Fatigue Impact Scale" (MFIS) | baseline, after 4 weeks | |
Primary | Change of pain intensity | Assessment of pain level using a "Visual Analogue Scale" (VAS) for pain | baseline, after 4 weeks | |
Primary | Motivation. | Survey made from questions for subjective self-evaluation of motivation efficiency. | baseline, after 4 weeks | |
Primary | 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 | |
Primary | Change of mental abilities and limitations. | Assessment of cognitive ability using the "Standardized Mini-Mental State Examination" test (SMMSE). | baseline | |
Primary | 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. | |
Primary | Change of grip strength. | Grip strength testing using hand hydraulic dynamometer. | baseline, after 4 weeks |
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