Multiple SclerosisNCT03976128
Endurance and Walking Training by Nordic Walking in Multiple Sclerosis
A study testing Nordic Walking Training and Conventional endurance training in people with Multiple Sclerosis, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Nordic Walking Training and Conventional endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Nordic Walking Training, Conventional endurance training
- Keywords
- endurance training, nordic walking, walking ability, fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nordic Walking TrainingBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nordic Walking training | Experimental | 20 sessions of 45 minutes x 2 times/week x 10 weeks using NW Receives: 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. Receives: Behavioral: Conventional endurance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test (6MWT)
Maximal distance (in meters) walked during 6 minutes
Measured: 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
Measured: Assessment will take place up to 6 months, through the study completion
Secondary outcomes (14)
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.
Measured: Assessment will take place at baseline and after 10 weeks
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.
Measured: Assessment will take place up to 6 months, through the study completion
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.
Measured: Assessment will take place at baseline and after 10 weeks
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.
Measured: Assessment will take place up to 6 months, through the study completion
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.
Measured: Assessment will take place at baseline and after 10 weeks
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.
Measured: Assessment will take place up to 6 months, through the study completion
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
Measured: Assessment will take place at baseline and after 10 weeks
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
Measured: Assessment will take place up to 6 months, through the study completion
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%
Measured: Assessment will take place at baseline and after 10 weeks
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%
Measured: Assessment will take place up to 6 months, through the study completion
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.
Measured: Assessment will take place at baseline and after 10 weeks
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.
Measured: Assessment will take place up to 6 months, through the study completion
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.
Measured: Assessment will take place at baseline and after 10 weeks
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.
Measured: Assessment will take place up to 6 months, through the study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study startSep 2016
- Primary completionJun 2019
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Multiple Sclerosis Center of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carme Santoyo Medina, PT, MSc, Principal investigator, Multiple Sclerosis Center of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976128
- Sponsor's protocol ID
- Nordic Walking in MS
- Status last verified
- Sep 2022
- First submitted
- 1 Jun 2019
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28391781de Sa J. [Epidemiology of multiple sclerosis in Portugal and Spain]. Rev Neurol. 2010 Oct 1;51(7):387-92. No abstract available. Spanish.
PubMed 20859919Otero 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.
PubMed 20473839Lublin 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.
PubMed 24871874Tallner 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.
PubMed 21733890Motl 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.
PubMed 16042230Rietberg 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.
PubMed 15674920Motl 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.
PubMed 21597305Dalgas 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.
PubMed 17881393Dalgas 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.
PubMed 20194584Newman 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.
PubMed 17294619Mostert 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.
PubMed 11990874Weikert 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.
PubMed 24453701McAuley 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.
PubMed 17548446Dettmers 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.
PubMed 19178385
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03976128
- Acronym / sponsor ID
- Nordic Walking in MS
- Conditions
- Multiple Sclerosis
- Keywords
- endurance training, nordic walking, walking ability, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Multiple Sclerosis Center of CataloniaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nordic Walking training | Experimental | Behavioral: Nordic Walking Training20 sessions of 45 minutes x 2 times/week x 10 weeks using NW |
| Conventional endurance training | Active comparator | Behavioral: Conventional endurance training20 sessions of 45 minutes x 2 times/week x 10 weeks using treadmill and cycloergometer training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nordic Walking TrainingThe 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. | Behavioural | Nordic Walking training |
| Conventional endurance training15 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. | Behavioural | Conventional endurance training |
Primary outcome
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
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
14 secondary outcomes
Timed 25 Foot Walk Test
Time frame: Assessment will take place at baseline and after 10 weeks
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
Multiple Sclerosis Walking Scale 12
Time frame: Assessment will take place at baseline and after 10 weeks
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
Timed Up and Go Test
Time frame: Assessment will take place at baseline and after 10 weeks
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
Berg Balance Scale
Time frame: Assessment will take place at baseline and after 10 weeks
Change from baseline Berg Balance Scale to 6 months
Time frame: Assessment will take place up to 6 months, through the study completion
Activities Specific Balance Confidence Scale
Time frame: Assessment will take place at baseline and after 10 weeks
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
Modified Fatigue Impact Scale
Time frame: Assessment will take place at baseline and after 10 weeks
Change from baseline Modified Fatigue Impact Scale to 6 months
Time frame: Assessment will take place up to 6 months, through the study completion
Multiple Sclerosis Quality of Life 54
Time frame: Assessment will take place at baseline and after 10 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Background: PubMed 28391781Vidal-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.
- Background: PubMed 20859919de Sa J. [Epidemiology of multiple sclerosis in Portugal and Spain]. Rev Neurol. 2010 Oct 1;51(7):387-92. No abstract available. Spanish.
- Background: PubMed 20473839Otero 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.
- Background: PubMed 24871874Lublin 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.
- Background: PubMed 21733890Tallner 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.
- Results publication: PubMed 16042230Motl 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.
- Results publication: PubMed 15674920Rietberg 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.
- Results publication: PubMed 21597305Motl 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.
- Results publication: PubMed 17881393Dalgas 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.
- Results publication: PubMed 20194584Dalgas 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.
- Results publication: PubMed 17294619Newman 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.
- Results publication: PubMed 11990874Mostert 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Santoyo Medina, PT, MSc principal investigator
Multiple Sclerosis Center of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nordic Walking Training and Conventional endurance training in people with Multiple Sclerosis, run by Multiple Sclerosis Center of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (6MWT) (time frame: Assessment will take place at baseline and after 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976128, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.