Clinical trial NCT03976128: Endurance and Walking Training by Nordic Walking in Multiple Sclerosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: endurance training
nordic walking
walking ability
fatigue
Lead sponsor: Multiple Sclerosis Center of Catalonia
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6 Minute Walk Test (6MWT)
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline 6 Minute Walk Test (6MWT) to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
Secondary outcomes:
measure: Timed 25 Foot Walk Test
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Timed 25 Foot Walk Test to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
measure: Multiple Sclerosis Walking Scale 12
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Multiple Sclerosis Walking Scale 12 to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
measure: Timed Up and Go Test
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Timed Up and Go Test to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
measure: Berg Balance Scale
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Berg Balance Scale to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
measure: Activities Specific Balance Confidence Scale
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Activities Specific Balance Confidence Scale to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
measure: Modified Fatigue Impact Scale
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Modified Fatigue Impact Scale to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
measure: Multiple Sclerosis Quality of Life 54
timeFrame: Assessment will take place at baseline and after 10 weeks
measure: Change from baseline Multiple Sclerosis Quality of Life 54 to 6 months
timeFrame: Assessment will take place up to 6 months, through the study completion
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Multiple Sclerosis Center of Catalonia
Study officials:
affiliation: Multiple Sclerosis Center of Catalonia
name: Carme Santoyo Medina, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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