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Endurance and Walking Training by Nordic Walking in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nordic Walking Training
Conventional endurance training
Sponsored by
Multiple Sclerosis Center of Catalonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring endurance training, nordic walking, walking ability, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Multiple Sclerosis Center of Catalonia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nordic Walking training

Conventional endurance training

Arm Description

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

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

Outcomes

Primary Outcome Measures

6 Minute Walk Test (6MWT)
Maximal distance (in meters) walked during 6 minutes
Change from baseline 6 Minute Walk Test (6MWT) to 6 months
Maximal distance (in meters) walked during 6 minutes

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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
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
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%
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%
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.
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.
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.
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.

Full Information

First Posted
June 1, 2019
Last Updated
September 14, 2022
Sponsor
Multiple Sclerosis Center of Catalonia
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1. Study Identification

Unique Protocol Identification Number
NCT03976128
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Multiple Sclerosis Center of Catalonia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
endurance training, nordic walking, walking ability, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nordic Walking training
Arm Type
Experimental
Arm Description
20 sessions of 45 minutes x 2 times/week x 10 weeks using NW
Arm Title
Conventional endurance training
Arm Type
Active Comparator
Arm Description
20 sessions of 45 minutes x 2 times/week x 10 weeks using treadmill and cycloergometer training.
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional endurance training
Intervention Description
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 Measure Information:
Title
6 Minute Walk Test (6MWT)
Description
Maximal distance (in meters) walked during 6 minutes
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline 6 Minute Walk Test (6MWT) to 6 months
Description
Maximal distance (in meters) walked during 6 minutes
Time Frame
Assessment will take place up to 6 months, through the study completion
Secondary Outcome Measure Information:
Title
Timed 25 Foot Walk Test
Description
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.
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Timed 25 Foot Walk Test to 6 months
Description
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.
Time Frame
Assessment will take place up to 6 months, through the study completion
Title
Multiple Sclerosis Walking Scale 12
Description
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.
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Multiple Sclerosis Walking Scale 12 to 6 months
Description
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.
Time Frame
Assessment will take place up to 6 months, through the study completion
Title
Timed Up and Go Test
Description
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.
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Timed Up and Go Test to 6 months
Description
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.
Time Frame
Assessment will take place up to 6 months, through the study completion
Title
Berg Balance Scale
Description
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
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Berg Balance Scale to 6 months
Description
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
Time Frame
Assessment will take place up to 6 months, through the study completion
Title
Activities Specific Balance Confidence Scale
Description
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%
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Activities Specific Balance Confidence Scale to 6 months
Description
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%
Time Frame
Assessment will take place up to 6 months, through the study completion
Title
Modified Fatigue Impact Scale
Description
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.
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Modified Fatigue Impact Scale to 6 months
Description
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.
Time Frame
Assessment will take place up to 6 months, through the study completion
Title
Multiple Sclerosis Quality of Life 54
Description
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.
Time Frame
Assessment will take place at baseline and after 10 weeks
Title
Change from baseline Multiple Sclerosis Quality of Life 54 to 6 months
Description
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.
Time Frame
Assessment will take place up to 6 months, through the study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carme Santoyo Medina, PT, MSc
Organizational Affiliation
Multiple Sclerosis Center of Catalonia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple Sclerosis Center of Catalonia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Endurance and Walking Training by Nordic Walking in Multiple Sclerosis

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