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

NCT02870023 | Completed

• 1 other identifier: 14695664
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Change in gait speed measured by "Six Spot Step Test"

  Six Spot Step Test

  At baseline and again after 10 weeks

• Change in gait speed measured by "Timed 25 Foot Walk"

  Timed 25 Foot Walk

  At baseline and again after 10 weeks

Secondary Outcomes (8)

• Fatigue

  At baseline and after 10 weeks

• Endurance

  At baseline and after 10 weeks

• Self-evaluated gait function

  At baseline and after 10 weeks

• Temporospatial measures

  At baseline and after 10 weeks

• Balance - static

  At baseline and after 10 weeks

Other Outcomes (1)

• General health

  At baseline and after 10 weeks

Study Arms (3)

Balance training

EXPERIMENTAL

All sessions will start with a ten minute warm-up on either a treadmill or a cycle. The balance intervention will be conducted in stations/domains where balance is challenged in the five different functions: standing, walking, sit to stand, stepping, and a station that exercises vestibular and gaze control. Progression is achieved by adding exercises with increased balance requirements and by adding additional motoric and cognitive tasks to the exercises-dual-tasking. Intensity of the exercises is defined from an error-rate where an adequate level is 20-40 percent. The intervention is conducted according to a standardized framework that describes examples of exercises and progressions.

Other: Balance training

Strength training

EXPERIMENTAL

All sessions will start with a ten minute warm-up on a stationary bicycle, followed by strength training of primary muscle synergies in the lower extremities. All exercises will be performed on machines with patients sitting or lying, adequately supported. The exercises are leg press, knee extension, hip flexion, hamstring curl, and hip extension. Exercises are performed with a fast concentric phase and a slow eccentric phase.. Set, repetition, and load: * Weeks 1 and 2, 3 sets of 10 repetitions at a load of 15 repetitions maximum (RM) * Weeks 3 and 4, 3 sets of 12 repetitions at a load of 12RM * Weeks 5 and 6, 4 sets of 12 repetitions at a load of 12RM * Weeks 7 and 8, 4 sets of 10 repetitions at a load of 10RM * Weeks 9 and 10, 4 sets of 8 repetitions at a load of 8RM.

Other: Strength training

Control group

NO INTERVENTION

On a waitlist. After ten weeks of waiting, and intervention that contains 50 percent strength training and 50 percent balance training begins.

Interventions

Balance training OTHER

Balance training

Strength training OTHER

Strength training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Co-morbidity in terms of dementia and alcohol abuse.
• Attack within the last eight weeks.
• Systematic intensive rehabilitation/training within the last three months.

Sponsors & Collaborators

• University of Aarhus: lead
• VIA University College: collaborator
• TrygFonden, Denmark: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Department of Public Health - Sport Science

Aarhus, 8000, Denmark

Location

Related Publications (13)

• 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.

  PMID: 22236888 BACKGROUND

• 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.

  PMID: 23153337 BACKGROUND

• Penner IK, Bechtel N, Raselli C, Stocklin 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. doi: 10.1177/1352458507079267.

  PMID: 17967844 BACKGROUND

• 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.

  PMID: 21467189 BACKGROUND

• Corporaal SH, Gensicke H, Kuhle J, Kappos L, Allum JH, Yaldizli O. 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.

  PMID: 22874664 BACKGROUND

• 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.

  PMID: 20156050 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.

  PMID: 23200463 BACKGROUND

• 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.

  PMID: 22825702 BACKGROUND

• 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.

  PMID: 19884575 BACKGROUND

• 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. doi: 10.1123/mcj.16.1.50.

  PMID: 22402220 BACKGROUND

• 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. doi: 10.1177/0269215507077602.

  PMID: 17875557 BACKGROUND

• Paltamaa J, Sjogren 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.

  PMID: 22990349 BACKGROUND

• Callesen J, Cattaneo D, Brincks J, Dalgas U. How does strength training and balance training affect gait and fatigue in patients with Multiple Sclerosis? A study protocol of a randomized controlled trial. NeuroRehabilitation. 2018;42(2):131-142. doi: 10.3233/NRE-172238.

  PMID: 29562556 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jacob Callesen, PT, MHSc

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 17, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 19, 2019

Record last verified: 2019-02

Locations

DK (1)