Endurance and Walking Training by Nordic Walking in Multiple Sclerosis

NCT03976128 | Completed DMC

• 1 other identifier: Nordic Walking in MS
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Walking capacity is one of the most valuable body functions among persons with multiple sclerosis (MS) and it is one of the most frequently affected, even in early stages of the disease. Inactivity and deconditioning can accelerate gait impairment and promote other pathologies related with sedentary lifestyle. Nordic walking (NW) is a fun and effective fitness and rehabilitation activity. The benefits of NW have been extensively described in healthy and elderly population (Tschentscher, 2013; Kappor, 2013) and it is proving to be highly recommended to different neurological conditions, specially to Parkinson Disease (Reuter 2006; van Eijkeren 2008; Fritz 2011; Ebersbach 2014). There is no evidence on NW and MS, although it's supposed to be an ideal physical activity for many reasons: it tones the upper and lower body at the same time, uses 90% of the skeletal muscles, burns up to 46% more calories than ordinary walking, reduces the pressure on knees and joints, poles propel the walker along easier and faster and it is one of the most effective cross training techniques for people who require improve cardiovascular and endurance conditioning.

Conditions

Multiple Sclerosis

Keywords

endurance training; nordic walking; walking ability; fatigue

Outcome Measures

Primary Outcomes (2)

• 6 Minute Walk Test (6MWT)

  Maximal distance (in meters) walked during 6 minutes

  Assessment will take place at baseline and after 10 weeks

• Change from baseline 6 Minute Walk Test (6MWT) to 6 months

  Maximal distance (in meters) walked during 6 minutes

  Assessment will take place up to 6 months, through the study completion

Secondary Outcomes (14)

• Timed 25 Foot Walk Test

  Assessment will take place at baseline and after 10 weeks

• Change from baseline Timed 25 Foot Walk Test to 6 months

  Assessment will take place up to 6 months, through the study completion

• Multiple Sclerosis Walking Scale 12

  Assessment will take place at baseline and after 10 weeks

• Change from baseline Multiple Sclerosis Walking Scale 12 to 6 months

  Assessment will take place up to 6 months, through the study completion

• Timed Up and Go Test

  Assessment will take place at baseline and after 10 weeks

Study Arms (2)

Nordic Walking training

EXPERIMENTAL

20 sessions of 45 minutes x 2 times/week x 10 weeks using NW

Behavioral: Nordic Walking Training

Conventional endurance training

ACTIVE COMPARATOR

20 sessions of 45 minutes x 2 times/week x 10 weeks using treadmill and cycloergometer training.

Behavioral: Conventional endurance training

Interventions

Nordic Walking Training BEHAVIORAL

The excursions will take place predominantly in flat pathways, beginning in a local park and progressing to roadside footpaths. Each session will last an hour including a warm up, NW and a cool down with stretching exercises.

Nordic Walking training

Conventional endurance training BEHAVIORAL

15 minutes of Treadmill training with progressive increase of velocity followed by 20 minutes of cycloergometer with progressive increase of resistance. Each session will last an hour including a warm up, training with treadmill and cycloergometer and a cool down with stretching exercises.

Conventional endurance training

Eligibility Criteria

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

You may qualify if:

• People over 18 diagnosed of MS following the Mc Donald criteria, clinically stable who:
• show mild to moderate balance disorder (BBS\>45). Mild risk of falls.
• refer fatigue during walking and restriction on their usual walking distance during the last 6 months.
• Accept to participate in the study and signed the informed consent.

You may not qualify if:

• Other neurological disorders.
• Moderate to severe spasticity (Ashworth\>2)
• Non stable heart diseases, diabetes mellitus, arthritis in lower limbs, acute pain in lower limbs, peripheral neuropathies, severe orthopedics problems, psychiatric problems, pregnancy.
• Incapacity to maintain a minimum walking rhythm at least during 15 minutes.
• Cognitive disability or body schema disorder that limits to fill in the assessment questionaires or understanding and applying the technique.
• To be training in other physical activities that can modify the level of fatigue or walking ability.

Sponsors & Collaborators

• Multiple Sclerosis Center of Catalonia: lead

Study Sites (1)

Multiple Sclerosis Center of Catalonia

Barcelona, 08035, Spain

Location

Related Publications (16)

• Vidal-Jordana A, Montalban X. Multiple Sclerosis: Epidemiologic, Clinical, and Therapeutic Aspects. Neuroimaging Clin N Am. 2017 May;27(2):195-204. doi: 10.1016/j.nic.2016.12.001.

  PMID: 28391781 BACKGROUND

• de Sa J. [Epidemiology of multiple sclerosis in Portugal and Spain]. Rev Neurol. 2010 Oct 1;51(7):387-92. No abstract available. Spanish.

  PMID: 20859919 BACKGROUND

• Otero S, Batlle J, Bonaventura I, Brieva L, Bufill E, Cano A, Carmona O, Escartin A, Marco M, Moral E, Munteis E, Nos C, Pericot I, Perkal H, Ramio-Torrenta L, Ramo-Tello C, Saiz A, Sastre-Garriga J, Tintore M, Vaque J, Montalban X; Grupo de Trabajo del Registro de Esclerosis Multiple de Cataluna. [Multiple sclerosis epidemiological situation update: pertinence and set-up of a population based registry of new cases in Catalonia]. Rev Neurol. 2010 May 16;50(10):623-33. Spanish.

  PMID: 20473839 BACKGROUND

• Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sorensen PS, Thompson AJ, Wolinsky JS, Balcer LJ, Banwell B, Barkhof F, Bebo B Jr, Calabresi PA, Clanet M, Comi G, Fox RJ, Freedman MS, Goodman AD, Inglese M, Kappos L, Kieseier BC, Lincoln JA, Lubetzki C, Miller AE, Montalban X, O'Connor PW, Petkau J, Pozzilli C, Rudick RA, Sormani MP, Stuve O, Waubant E, Polman CH. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86. doi: 10.1212/WNL.0000000000000560. Epub 2014 May 28.

  PMID: 24871874 BACKGROUND

• Tallner A, Waschbisch A, Wenny I, Schwab S, Hentschke C, Pfeifer K, Maurer M. Multiple sclerosis relapses are not associated with exercise. Mult Scler. 2012 Feb;18(2):232-5. doi: 10.1177/1352458511415143. Epub 2011 Jul 6.

  PMID: 21733890 BACKGROUND

• Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. doi: 10.1191/1352458505ms1188oa.

  PMID: 16042230 RESULT

• Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003980. doi: 10.1002/14651858.CD003980.pub2.

  PMID: 15674920 RESULT

• Motl RW, Fernhall B, McAuley E, Cutter G. Physical activity and self-reported cardiovascular comorbidities in persons with multiple sclerosis: evidence from a cross-sectional analysis. Neuroepidemiology. 2011;36(3):183-91. doi: 10.1159/000327749. Epub 2011 May 20.

  PMID: 21597305 RESULT

• Dalgas U, Stenager E, Ingemann-Hansen T. Multiple sclerosis and physical exercise: recommendations for the application of resistance-, endurance- and combined training. Mult Scler. 2008 Jan;14(1):35-53. doi: 10.1177/1352458507079445. Epub 2007 Sep 19.

  PMID: 17881393 RESULT

• Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Fatigue, mood and quality of life improve in MS patients after progressive resistance training. Mult Scler. 2010 Apr;16(4):480-90. doi: 10.1177/1352458509360040. Epub 2010 Mar 1.

  PMID: 20194584 RESULT

• Newman MA, Dawes H, van den Berg M, Wade DT, Burridge J, Izadi H. Can aerobic treadmill training reduce the effort of walking and fatigue in people with multiple sclerosis: a pilot study. Mult Scler. 2007 Jan;13(1):113-9. doi: 10.1177/1352458506071169.

  PMID: 17294619 RESULT

• Mostert S, Kesselring J. Effects of a short-term exercise training program on aerobic fitness, fatigue, health perception and activity level of subjects with multiple sclerosis. Mult Scler. 2002 Apr;8(2):161-8. doi: 10.1191/1352458502ms779oa.

  PMID: 11990874 RESULT

• Weikert M, Dlugonski D, Balantrapu S, Motl RW. Most common types of physical activity self-selected by people with multiple sclerosis. Int J MS Care. 2011 Spring;13(1):16-20. doi: 10.7224/1537-2073-13.1.16.

  PMID: 24453701 RESULT

• McAuley E, Motl RW, Morris KS, Hu L, Doerksen SE, Elavsky S, Konopack JF. Enhancing physical activity adherence and well-being in multiple sclerosis: a randomised controlled trial. Mult Scler. 2007 Jun;13(5):652-9. doi: 10.1177/1352458506072188. Epub 2007 Feb 9.

  PMID: 17548446 RESULT

• Dettmers C, Sulzmann M, Ruchay-Plossl A, Gutler R, Vieten M. Endurance exercise improves walking distance in MS patients with fatigue. Acta Neurol Scand. 2009 Oct;120(4):251-7. doi: 10.1111/j.1600-0404.2008.01152.x. Epub 2009 Jan 28.

  PMID: 19178385 RESULT

• Pilutti LA, Platta ME, Motl RW, Latimer-Cheung AE. The safety of exercise training in multiple sclerosis: a systematic review. J Neurol Sci. 2014 Aug 15;343(1-2):3-7. doi: 10.1016/j.jns.2014.05.016. Epub 2014 May 15.

  PMID: 24880538 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carme Santoyo Medina, PT, MSc

  Multiple Sclerosis Center of Catalonia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 1, 2019
• First Posted: June 5, 2019
• Study Start: September 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: March 1, 2020
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)