How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?

Multiple Sclerosis Clinical Trial

Official title:

How Does Strength Training and Balance Training Affect Gait Function and Fatigue in Patients With Multiple Sclerosis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870023
• Other study ID #: 14695664
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Multiple sclerosis (MS) is characterized by decreased strength and motor control, and compromised gait function. Reduced walking speed, balance, and fatigue are the cardinal symptoms. In rehabilitation, strength and balance training are commonly used. There is increasing scientific support of strength training for improving walking function. The evidence for balance training remains flawed. It is known that neurological damage in MS leads to increased cognitive processing in the planning of movements, which predisposes fatigue. Since fatigue is also associated with impaired balance, it can be hypothesized that motoric/balance training with an emphasis on cognitive load can affect gait and fatigue.

Purpose: The aim of the study is to determine whether there is a differentiated effect between strength and balance training measured by motor function, strength, balance, and fatigue.

Description:

People with MS experience a wide variety of symptoms including impaired muscle strength and balance, fatigue, impaired cognition, depression and spasticity. Of these, impaired balance and severe fatigue are described as two of the most debilitating symptoms leading to limitations in activities such as upright posture and gait. Generally, pharmacological symptomatic treatment has not proven efficient in the treatment of balance problems, fatigue and walking impairments, with the exception that Fampridine has beneficial effects on gait performance in a subgroup of patients. Consequently, non-pharmacological interventions that effectively target these symptoms are warranted.

In the last decade progressive resistance training (PRT) has proven to be one of the promising interventions in patients with MS showing a consistent and positive effect on muscle strength. However, the effect of PRT on functional outcomes are heterogeneous but with promising effects on daily activities such as walking and chair rise. The evidence for a beneficial effect of PRT on balance and postural control is divergent and yet inadequately investigated. Regarding fatigue, a recent Cochrane review reported that one could expect improvements in MS fatigue after exercise interventions, despite methodological flaws in the existing literature, but only few studies evaluating PRT were located.

Another promising intervention is task specific training of motor function that is widely used by physiotherapists in neurorehabilitation. In this study protocol, motor function is limited to gait related functions with a particular focus put on balance and motor control, why the term Balance and Motor Control Training (BMCT) is applied. There is no universally accepted definition of human balance, but balance defined as "the inherent ability of a person to maintain, achieve or restore a specific state of balance and not to fall, with reference to the motor and sensory systems and to the physical properties of the person", is applied in this study.

Effects obtained from BMCT partly result from plastic changes in the nervous system. To induce such effects, repetition of a simple task only has limited efficiency in order to improve performance. Once a task has been learned to a certain level, further practice of the same task will not be accompanied by further induction of plasticity and little is therefore gained by continued practice of the task. To provide challenges that ensures continued learning, training exercises have to progress from simple movement trajectories to more complex movements, that also incorporates goal setting. Moreover, it has been shown that shaping and variation of tasks in combination with feedback on movement quality is of great importance for the learning outcome. The underlying concept for performing BMCT is, therefore, that improved motor control will optimize the movement strategy, which further leads to improved gait function.

Regarding the effects of BMCT on fatigue, there are diverging results in the literature, but the literature on BMCT for patients with MS is generally of low quality with an inadequate description of interventions, why further studies are warranted.

Interestingly, the principles of task specific training do fundamentally contrast the principles of PRT, that normally consist of monotonous movement patterns performed under heavy loading for a low number of repetitions. Consequently, studies comparing the effects of BMCT and PRT on gait function would add to the current literature as no studies doing so could be located. Such a comparison would help clarify whether potential effects are overlapping or differentiated and would therefore help guiding future rehabilitation interventions in persons with MS.

The primary objective of this study is, therefore, to investigate and compare the effects of 10 weeks of PRT to BMCT on gait function, balance and fatigue in mobility limited persons with MS.

It is hypothesized that PRT will be superior in improving maximal straight gait speed, whereas BMCT will have a greater impact on balance, fatigue, and more complex walking tasks that include elements of balance and coordination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Diagnosed with multiple sclerosis.

• Expanded Disability Status Scale (EDSS) 2.0-6.5 and min. 2.0 in the functional system "pyramidal function".

• Able to walk 100 m.

• Able to manage own transportation in relation to weekly training and tests.

• Six spot step test score > 8 sec. or Timed 25 foot walk > 5 sec.

Exclusion criteria

• Co-morbidity in terms of dementia and alcohol abuse.

• Attack within the last eight weeks.

• Systematic intensive rehabilitation/training within the last three months.

• Adjustment of medication within two months before inclusion. This applies only for medication that affects gait performance and spasticity.

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Balance training

• Strength training

Locations

Country	Name	City	State
Denmark	Department of Public Health - Sport Science	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Fondazione Don Carlo Gnocchi Onlus, TrygFonden, Denmark, VIA University College

Country where clinical trial is conducted

Denmark, 

References & Publications (12)

Andreasen AK, Stenager E, Dalgas U. The effect of exercise therapy on fatigue in multiple sclerosis. Mult Scler. 2011 Sep;17(9):1041-54. doi: 10.1177/1352458511401120. Epub 2011 Apr 5. Review. — View Citation

Boes MK, Sosnoff JJ, Socie MJ, Sandroff BM, Pula JH, Motl RW. Postural control in multiple sclerosis: effects of disability status and dual task. J Neurol Sci. 2012 Apr 15;315(1-2):44-8. doi: 10.1016/j.jns.2011.12.006. Epub 2012 Jan 10. — View Citation

Cattaneo D, Jonsdottir J, Zocchi M, Regola A. Effects of balance exercises on people with multiple sclerosis: a pilot study. Clin Rehabil. 2007 Sep;21(9):771-81. — View Citation

Claros-Salinas D, Dittmer N, Neumann M, Sehle A, Spiteri S, Willmes K, Schoenfeld MA, Dettmers C. Induction of cognitive fatigue in MS patients through cognitive and physical load. Neuropsychol Rehabil. 2013;23(2):182-201. doi: 10.1080/09602011.2012.726925. Epub 2012 Nov 16. — View Citation

Corporaal SH, Gensicke H, Kuhle J, Kappos L, Allum JH, Yaldizli Ö. Balance control in multiple sclerosis: correlations of trunk sway during stance and gait tests with disease severity. Gait Posture. 2013 Jan;37(1):55-60. doi: 10.1016/j.gaitpost.2012.05.025. Epub 2012 Aug 5. — View Citation

Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4. — View Citation

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. — View Citation

Huisinga JM, Filipi ML, Stergiou N. Supervised resistance training results in changes in postural control in patients with multiple sclerosis. Motor Control. 2012 Jan;16(1):50-63. — View Citation

Kelleher KJ, Spence W, Solomonidis S, Apatsidis D. The characterisation of gait patterns of people with multiple sclerosis. Disabil Rehabil. 2010;32(15):1242-50. doi: 10.3109/09638280903464497. — View Citation

Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24. Review. — View Citation

Paltamaa J, Sjögren T, Peurala SH, Heinonen A. Effects of physiotherapy interventions on balance in multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. J Rehabil Med. 2012 Oct;44(10):811-23. doi: 10.2340/16501977-1047. Review. — View Citation

Penner IK, Bechtel N, Raselli C, Stöcklin M, Opwis K, Kappos L, Calabrese P. Fatigue in multiple sclerosis: relation to depression, physical impairment, personality and action control. Mult Scler. 2007 Nov;13(9):1161-7. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	General health	Short-Form Health Survey (SF-12)	At baseline and after 10 weeks
Primary	Change in gait speed measured by "Six Spot Step Test"	Six Spot Step Test	At baseline and again after 10 weeks
Primary	Change in gait speed measured by "Timed 25 Foot Walk"	Timed 25 Foot Walk	At baseline and again after 10 weeks
Secondary	Fatigue	Fatigue: Fatigue is measured according to the Danish version of the modified fatigue impact scale.	At baseline and after 10 weeks
Secondary	Endurance	Six-minute walk	At baseline and after 10 weeks
Secondary	Self-evaluated gait function	MS walking scale	At baseline and after 10 weeks
Secondary	Temporospatial measures	Gait in fastest and self-selected speed is recorded by a Qualisys system for 3D analysis. Determinants are step and stride length, step width, time in swing and stance, gait speed, and hip and knee angles during gait.	At baseline and after 10 weeks
Secondary	Balance - static	(modified) Clinical test for sensory interaction and balance (CTSIB). The test is conducted on a force plate that measures movement of center of pressure (COP). Outcome is length of COP trajectory and elliptic area.	At baseline and after 10 weeks
Secondary	Balance - functional	Mini BESTest	At baseline and after 10 weeks
Secondary	Balance - confidence	The Activities-specific Balance Confidence Scale	At baseline and after 10 weeks
Secondary	Strength	Maximum voluntary isometric contraction in knee flexion and extension. Maximum voluntary isometric and isokinetic contraction in dorsal and plantar flexion.	At baseline and after 10 weeks