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Trial record 10 of 2174 for:    MULTIPLE SCLEROSIS

Endurance and Walking Training by Nordic Walking in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT03976128
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Multiple Sclerosis Center of Catalonia

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.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Nordic Walking Training Behavioral: Conventional endurance training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nordic Walking training
20 sessions of 45 minutes x 2 times/week x 10 weeks using NW
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.

Active Comparator: Conventional endurance training
20 sessions of 45 minutes x 2 times/week x 10 weeks using treadmill and cycloergometer training.
Behavioral: 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.




Primary Outcome Measures :
  1. 6 Minute Walk Test (6MWT) [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    Maximal distance (in meters) walked during 6 minutes

  2. Change from baseline 6 Minute Walk Test (6MWT) to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    Maximal distance (in meters) walked during 6 minutes


Secondary Outcome Measures :
  1. Timed 25 Foot Walk Test [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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.

  2. Change from baseline Timed 25 Foot Walk Test to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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.

  3. Multiple Sclerosis Walking Scale 12 [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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.

  4. Change from baseline Multiple Sclerosis Walking Scale 12 to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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.

  5. Timed Up and Go Test [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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.

  6. Change from baseline Timed Up and Go Test to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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.

  7. Berg Balance Scale [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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

  8. Change from baseline Berg Balance Scale to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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

  9. Activities Specific Balance Confidence Scale [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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%

  10. Change from baseline Activities Specific Balance Confidence Scale to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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%

  11. Modified Fatigue Impact Scale [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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.

  12. Change from baseline Modified Fatigue Impact Scale to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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.

  13. Multiple Sclerosis Quality of Life 54 [ Time Frame: Assessment will take place at baseline and after 10 weeks ]
    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.

  14. Change from baseline Multiple Sclerosis Quality of Life 54 to 6 months [ Time Frame: Assessment will take place up to 6 months, through the study completion ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976128


Contacts
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Contact: Ingrid Galan Cartaña, Doctor +34 93 175 15 55 ext 3 igalan@cem-cat.org
Contact: Roger Meza, Doctor +34 93 175 15 55 ext 3 rmeza@cem-cat.org

Locations
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Spain
Multiple Sclerosis Center of Catalonia Recruiting
Barcelona, Spain, 08035
Contact: Carme Santoyo Medina, PT, MSc    +34 93 175 15 55 ext 3    csantoyo@cem-cat.org   
Sponsors and Collaborators
Multiple Sclerosis Center of Catalonia
Investigators
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Principal Investigator: Carme Santoyo Medina, PT, MSc Multiple Sclerosis Center of Catalonia

Publications of Results:

Other Publications:

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Responsible Party: Multiple Sclerosis Center of Catalonia
ClinicalTrials.gov Identifier: NCT03976128     History of Changes
Other Study ID Numbers: Nordic Walking in MS
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Multiple Sclerosis Center of Catalonia:
endurance training
nordic walking
walking ability
fatigue

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases