NCT03768830

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

Completed NA Last updated 16 April 2019

What this trial tests

NA trial testing Exercise training in Multiple Sclerosis in 50 participants. Completed in 5 February 2019.

Timeline

1 October 2018

Primary endpoint
5 February 2019

5 February 2019

Quick facts

Lead sponsor	University of Rijeka
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	1 October 2018
Primary completion	5 February 2019
Estimated completion	5 February 2019
Sites	1 location across Croatia

Drugs / interventions tested

• Exercise training

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Quality of Life — all drugs for Quality of Life →
• Motivation — all drugs for Motivation →
• Pain — all drugs for Pain →

Sponsor

University of Rijeka

Who can join

Adults 18 to 80, any sex, with Multiple Sclerosis or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.