Effect of Aerobic Training vs Balance Training on Fatigue Symptom in M
Comparison Between the Effects on Fatigue of Aerobic Training Versus Balance Training in Patients With Multiple Sclerosis: a Randomised Crossover Trial.
What it found
We found no results in the registry or in papers.
This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Aerobic training
- Balance training
What it measured
Main measures
Modified Fatigue Impact Scale Italian version
The Modified Fatigue Impact Scale was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 3
Fatigue
Other measures (3)
Equiscale
The Equiscale was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of
Walking and mobilityEquitest® Sensory Organization Test
The Sensory Organization Test was computed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 da
Walking and mobilityGait speed
The gait speed was assessed: before intervention, at end of first intervention, 30 days after end of first intervention, before second intervention, at end of second intervention, 30 days after end of
Walking and mobility
Who could take part
Relapsing and progressive · EDSS 2 to 6
Show the full criteria
Inclusion criteria
* MS diagnosis according to the revised McDonalds criteria. Relapsing-remitting, primary and secondary progressive MS forms are allowed; * Expanded Disability Status Scale (EDSS) between 2 and 6, included; * Fatigue as indicated by a total score of mFIS ≥ 20/84; * Balance impairment as indicated by a performance at the Equitest Sensory Organisation Test below age-matched normal values (95th percentile of control values).
Exclusion criteria
* Any of the following in the month before enrolment: an MS relapse; current corticosteroids therapy because of MS; change in medicines prescribed against fatigue; attending an intensive physical therapy program; * New or active lesions on a brain or spinal cord MRI scan in the 12 months before the study enrolment; * Angioplasty for chronic cerebrospinal venous insufficiency in the six months before enrolment; * Any musculoskeletal disease or any additional neurological disorder which causes by itself a balance or gait impairment; * Any other condition causing fatigue by itself; * Any unstable cardiological disease.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Fatigue and impaired balance frequently affect patients with Multiple Sclerosis (MS). This is an open, prospective randomised crossover trial aimed at clarifying whether an improvement in balance control after balance training would also improve fatigue in patients with MS. Balance training will be compared to aerobic training, which is known to be effective on fatigue.
Papers
Background
Bakshi R, Shaikh ZA, Miletich RS, Czarnecki D, Dmochowski J, Henschel K, Janardhan V, Dubey N, Kinkel PR. Fatigue in multiple sclerosis and its relationship to depression and neurologic disability. Mult Scler. 2000 Jun;6(3):181-5. doi: 10.1177/135245850000600308.Background
Brichetto G, Piccardo E, Pedulla L, Battaglia MA, Tacchino A. Tailored balance exercises on people with multiple sclerosis: A pilot randomized, controlled study. Mult Scler. 2015 Jul;21(8):1055-63. doi: 10.1177/1352458514557985. Epub 2014 Nov 12.Background
Flachenecker P, Kumpfel T, Kallmann B, Gottschalk M, Grauer O, Rieckmann P, Trenkwalder C, Toyka KV. Fatigue in multiple sclerosis: a comparison of different rating scales and correlation to clinical parameters. Mult Scler. 2002 Dec;8(6):523-6. doi: 10.1191/1352458502ms839oa.Background
Giesser BS. Exercise in the management of persons with multiple sclerosis. Ther Adv Neurol Disord. 2015 May;8(3):123-30. doi: 10.1177/1756285615576663.Background
Giovannoni G. Multiple sclerosis related fatigue. J Neurol Neurosurg Psychiatry. 2006 Jan;77(1):2-3. doi: 10.1136/jnnp.2005.074948.Background
Hebert JR, Corboy JR. The association between multiple sclerosis-related fatigue and balance as a function of central sensory integration. Gait Posture. 2013 May;38(1):37-42. doi: 10.1016/j.gaitpost.2012.10.015. Epub 2012 Nov 28.Background
Hebert JR, Corboy JR, Manago MM, Schenkman M. Effects of vestibular rehabilitation on multiple sclerosis-related fatigue and upright postural control: a randomized controlled trial. Phys Ther. 2011 Aug;91(8):1166-83. doi: 10.2522/ptj.20100399. Epub 2011 Jun 16.Background
Khan F, Amatya B, Galea M. Management of fatigue in persons with multiple sclerosis. Front Neurol. 2014 Sep 15;5:177. doi: 10.3389/fneur.2014.00177. eCollection 2014.Background
Kos D, Kerckhofs E, Carrea I, Verza R, Ramos M, Jansa J. Evaluation of the Modified Fatigue Impact Scale in four different European countries. Mult Scler. 2005 Feb;11(1):76-80. doi: 10.1191/1352458505ms1117oa.Background
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
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History
Started
Feb 2016
Main results due
Nov 2019
Finished
Dec 2019