Endurance and Walking Training by Nordic Walking in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Effect of Nordic Walking Training Compared With Conventional Endurance Training in Walking Capacity in People With Multiple Sclerosis: a Simple Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03976128
• Other study ID #: Nordic Walking in MS
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2020

Study information

• Verified date: September 2022
• Source: Multiple Sclerosis Center of Catalonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A simple blinded randomized controlled trial as designed to assess if an endurance training (20 sessions of 45 minutes x 2 times/week x 10 weeks) using NW improves: walking capacity, balance, fatigue, mood and health-related quality of life of people with MS.

66 people with MS will be randomly allocated in NW group or conventional endurance training group (treadmill and cycloergometer). Assessments will take place before starting the training, after the training and 3 months after.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Nordic Walking Training
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.
• Conventional endurance training
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.

Locations

Country	Name	City	State
Spain	Multiple Sclerosis Center of Catalonia	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Multiple Sclerosis Center of Catalonia

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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. Epub 2007 Sep 19. Review. — View Citation

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: 10.1177/13524585093 — View Citation

de Sá J. [Epidemiology of multiple sclerosis in Portugal and Spain]. Rev Neurol. 2010 Oct 1;51(7):387-92. Spanish. — View Citation

Dettmers C, Sulzmann M, Ruchay-Plössl A, Gütler 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. — View Citation

Lublin FD, Reingold SC, Cohen JA, Cutter GR, Sørensen 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, Stüve 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. — View Citation

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. Epub 2007 Feb 9. — View Citation

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. — View Citation

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 201 — View Citation

Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. — View Citation

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. — View Citation

Otero S, Batlle J, Bonaventura I, Brieva L, Bufill E, Cano A, Carmona O, Escartín A, Marco M, Moral E, Munteis E, Nos C, Pericot I, Perkal H, Ramió-Torrentà L, Ramo-Tello C, Saiz A, Sastre-Garriga J, Tintoré M, Vaqué J, Montalban X; Grupo de Trabajo del Registro de Esclerosis Múltiple de Cataluña. [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. — View Citation

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. Review. — View Citation

Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD003980. Review. — View Citation

Tallner A, Waschbisch A, Wenny I, Schwab S, Hentschke C, Pfeifer K, Mäurer 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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 Minute Walk Test (6MWT)	Maximal distance (in meters) walked during 6 minutes	Assessment will take place at baseline and after 10 weeks
Primary	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	Timed 25 Foot Walk Test	The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Timed 25 Foot Walk Test to 6 months	The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.	Assessment will take place up to 6 months, through the study completion
Secondary	Multiple Sclerosis Walking Scale 12	12-item self reported measure of the impact of MS on individual's walking ability. Each item scoring provides options 1-5, with 1 meaning no limitation and 5 meaning extreme limitation on the gait related item. The total score ranges between 12 and 60, with higher scores indicating more limitation perceived on walking ability.	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Multiple Sclerosis Walking Scale 12 to 6 months	12-item self reported measure of the impact of MS on individual's walking ability. Each item scoring provides options 1-5, with 1 meaning no limitation and 5 meaning extreme limitation on the gait related item. The total score ranges between 12 and 60, with higher scores indicating more limitation perceived on walking ability.	Assessment will take place up to 6 months, through the study completion
Secondary	Timed Up and Go Test	Time in seconds required to walk to a line that is 3 meters (9.8 feet) away, turn around at the line, walk back to the chair, and sit down.	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Timed Up and Go Test to 6 months	Time in seconds required to walk to a line that is 3 meters (9.8 feet) away, turn around at the line, walk back to the chair, and sit down.	Assessment will take place up to 6 months, through the study completion
Secondary	Berg Balance Scale	The Berg Balance Scale (BBS)14-item objective measure that assesses static balance and fall risk in adults. Items include static and dynamic activities with varying difficulty. Each item scoring provides options 0-4, determined by the ability to perform the assessed ability. Item score are then summed ranging between 12 and 60, with higher scores indicating better balance ability	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Berg Balance Scale to 6 months	The Berg Balance Scale (BBS)14-item objective measure that assesses static balance and fall risk in adults. Items include static and dynamic activities with varying difficulty. Each item scoring provides options 0-4, determined by the ability to perform the assessed ability. Item score are then summed ranging between 12 and 60, with higher scores indicating better balance ability	Assessment will take place up to 6 months, through the study completion
Secondary	Activities Specific Balance Confidence Scale	The Activities Specific Balance Confidence Scale(ABC scale) is a reported measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The scale has 16 items (score 0-1600 possible). The score is recorded as a percentage (%), with 100% the highest level of confidence. Max score of 1600 divided by 16 items = 100%	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Activities Specific Balance Confidence Scale to 6 months	The Activities Specific Balance Confidence Scale(ABC scale) is a reported measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. The scale has 16 items (score 0-1600 possible). The score is recorded as a percentage (%), with 100% the highest level of confidence. Max score of 1600 divided by 16 items = 100%	Assessment will take place up to 6 months, through the study completion
Secondary	Modified Fatigue Impact Scale	The Modified Fatigue Impact Scale (MFIS) is a form of the Fatigue Impact Scale (Fisk et al, 1994) based on items derived from interviews with MS patients concerning how fatigue interferes in their lifes. The instrument provides an assessment of the effect of fatigue in terms of physical, mental and psychosocial functioning. Items on the MFIS can be aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The Physical Subscale range from 0 to 36. The Cognitive Subscale ranges from 0 to 40. The Psychosocial Subscale ranges from 0 to 8.The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Modified Fatigue Impact Scale to 6 months	The Modified Fatigue Impact Scale (MFIS) is a form of the Fatigue Impact Scale (Fisk et al, 1994) based on items derived from interviews with MS patients concerning how fatigue interferes in their lifes. The instrument provides an assessment of the effect of fatigue in terms of physical, mental and psychosocial functioning. Items on the MFIS can be aggregated into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities. The Physical Subscale range from 0 to 36. The Cognitive Subscale ranges from 0 to 40. The Psychosocial Subscale ranges from 0 to 8.The total MFIS score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.	Assessment will take place up to 6 months, through the study completion
Secondary	Multiple Sclerosis Quality of Life 54	The Multiple Sclerosis Quality of Life 54 (MSQoL-54) is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary, that are derived from a weighted combination of scale scores. Higher scores means better quality of life perceived.	Assessment will take place at baseline and after 10 weeks
Secondary	Change from baseline Multiple Sclerosis Quality of Life 54 to 6 months	The Multiple Sclerosis Quality of Life 54 (MSQoL-54) is a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 subscales along with two summary scores, and two additional single-item measures. The subscales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The summary scores are the physical health composite summary and the mental health composite summary, that are derived from a weighted combination of scale scores. Higher scores means better quality of life perceived.	Assessment will take place up to 6 months, through the study completion