Multiple Sclerosis"MS-Fit"NCT02440516
Standardized Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis
A study testing Early treatment group and Late treatment group in people with Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Early treatment group and Late treatment group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Feb 2016to 26 Feb 2019
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS)
- Age between 18 and 75 years
- Written informed consent
- Patient complains about MS related disability that affects ADL and/or QoL
Who cannot join
- A relapse that started within 60 days prior to screening
- Rapidly progressive disease
- Any disease/condition that causes neurological deficits or disability besides MS
- A history of drug abuse in the 12 months prior to screening
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Neurology, Bern University Hospital
Bern, 3010
Department of Neurology, Cantonal hospital Luzern
Lucerne, 6000
About this study
Official title: Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. Despite increasing therapeutic options to ameliorate the disease course, most patients suffer from persistent neurological deficits over time.
Disability in MS has a negative impact on patients life's impairing activities of daily living (ADL) and quality of life (QoL) and leading to loss of work and the need providing care. This results in tremendous socioeconomic burden.
Read more
Disease-modifying treatments prevent disability progression in variable extent. However no drugs are available ameliorate persistent disability in MS. Therefore, exercise training as well as physical and occupational therapies are important in the symptomatic treatment of MS.
Physical and occupational therapy is usually performed close to patients home by therapist with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory neurorehabilitation program, integrating task oriented circuit training for MS patients to improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital settings.
Read the detailed description
Background
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. The incidence of MS is low in childhood and increases after the age of 18, reaching a peak between 20 and 40 years (mean age of 30 years) with women being affected approximately 2-5 years earlier than men. In Switzerland the incidence is thought to be 4:100.000 with approximately 12.500 affected patients.
Despite increasing therapeutic options to ameliorate the disease course, most patients suffer from persistent neurological deficits over time.
Neurologic symptoms can be manifold and are highly variable amongst patients. They include loss of vision, sensorimotor defects, impaired manual dexterity, ataxia, apraxia, gait disturbances, bladder- and bowl problems, fatigue, cognitive dysfunctions and others, which alone, or in combination, lead to disability in MS patients. Disability in MS has a negative impact on patients life's impairing activities of daily living (ADL) and quality of life (QoL) and leading to loss of work and the need providing care. This results in tremendous socioeconomic burden.
Disease-modifying treatments prevent disability progression in variable extent. However no drugs are available ameliorate persistent disability in MS. Therefore, exercise training as well as physical and occupational therapies are important in the symptomatic treatment of MS. Intensive task oriented circuit training has been shown to be effective in stroke improving gait, and several ADL. Some pilot randomized controlled trials in MS demonstrated exercise training being able to improve muscular strength, aerobic capacity and ambulatory performance as well as fatigue, balance and gait. Furthermore, specific therapies improve manual dexterity, coordination and mobilization in MS patients as well. Although, so far no randomized trial has been done to prove the effectiveness of task oriented circuit training in MS.
Physical and occupational therapy is usually performed close to patients home by therapist with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory neurorehabilitation program, integrating task oriented circuit training for MS patients to improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital settings.
Objective
To evaluate the impact of a standardized comprehensive ambulatory neurorehabilitation program on disability in patients with multiple sclerosis measured by performance based test of the upper and lower extremities and by patient recorded outcome measures regarding functioning of the upper and lower extremities, activities of daily living and quality of life.
The investigators hypothesize that this training program will improve disability, activities of daily living and quality of live in MS patients.
Methods
Prospective double center, randomized, cross-over study. Consecutive MS patients that complain about disability that affects ADL and/or QoL will be recruited to participate in a comprehensive ambulatory neurorehabilitation program. Afterwards baseline measurements will be performed and patients will be randomized 1:1 into the early treatment group or the delayed treatment group in groups of four using sealed envelopes. The early treatment group starts the neurorehabilitation program whereas in the delayed treatment group, patients will be put on a waiting list for two months. After two months, outcome measurements will be collected. Patients of the early treatment group stop the neurorehabilitation program and patients of the delayed treatment group start the neurorehabilitation program for two months ("cross-over design"). Two months after ending the program, each group will be retested.
- Conditions
- Multiple Sclerosis
- Being tested
- Early treatment group, Late treatment group
- Keywords
- Standardized, Physical therapy, occupational therapy, quality of life, disability, activities of daily living, ambulatory therapy, multiple sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early treatment groupOther
Physical- and occupational Therapy
Late treatment groupOther
Waiting list - then Physical- and occupational Therapy
| Study group | Role | What they receive |
|---|---|---|
| Neurorehabilitation program | Active comparator | Standardized comprehensive ambulatory neurorehabilitation program Receives: Other: Early treatment group |
| Waiting list | Placebo comparator | Waiting list Receives: Other: Late treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29)
The Multiple Sclerosis Impact Scale (MSIS-29) is valid and reliable (ICC 0.80 - 0.87) in measuring the impact of MS on ADL.It contains 29 items comprising to a physical (MSIS-29 physical) and psychological impact scale (MSIS-29 psychological). All items are scored from 'not at all' to 'extremely' on a five-point Likert scale.
Measured: 2 - 4 months
Secondary outcomes (7)
Change from baseline in Coin Rotation Task (Heldner et al. 2014)
The Coin Rotation Task (CRT) has been validated in assessing manual dexterity in patients with MS. Patients had to rotate a 50 Swiss Rappen coin (corresponding to a dime or 2-cent Euro coin) as fast as possible between their thumb, index and middle finger. The time to perform 20 half turns was measured twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken.
Measured: 0 - 2 - 4 months
Change from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007)
The Timed Up and Go test (TUG) is a test used to assess a person's mobility. It uses the time that a person takes to rise from a chair, walk three metres, turn around, walk back to the chair, and sit down.
Measured: 0 - 2 - 4 months
Change from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988)
The Nine Hole Peg Test (9HPT) is reliable (ICC values 0.80-0.99), valid and sensitive in detecting impaired dexterity in patients with MS. Patients were seated at a table with a shallow container holding nine pegs and a plastic block with nine empty holes. All pegs had to be put one at a time into the holes and then removed again one at a time into the shallow container. The time to complete the task was recorded twice on both hands and mean values were taken for each hand. If patients could not perform the CRT due to impaired manual dexterity, an arbitrarily chosen value of 300 seconds was taken.
Measured: 0 - 2 - 4 months
Change from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014)
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC to be administered at each visit. 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: 0 - 2 - 4 months
Change from baseline in EDSS
Measured: 0 - 2 - 4 months
Change from baseline in Rand 36
The RAND-36 is a license free version of the Short-Form Health Survey-36 (SF-36) containing eight scales.15 Each scale comprises two to ten items, and makes up to two summary measures. The scales measuring "physical functioning", "role-physical", "bodily pain" and "general health" form the "physical health summary score". The scales measuring "vitality", "social functioning", "role-emotional" and "mental health" form the "mental health summary score".
Measured: 0 - 2 - 4 months
Change from baseline in Fatigue Severity Scale
Measured: 0 - 2 - 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startFeb 2016
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian P Kamm, MD, Principal investigator, Department of Neurology, Cantonal hospital Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440516
- Sponsor's protocol ID
- 2015_04_29
- Acronym
- "MS-Fit"
- Status last verified
- Feb 2019
- First submitted
- 30 Apr 2015
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30.
PubMed 25095894Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. How responsive is the Multiple Sclerosis Impact Scale (MSIS-29)? A comparison with some other self report scales. J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1539-43. doi: 10.1136/jnnp.2005.064584.
PubMed 16227547Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24.
PubMed 22825702Lehmann I, Thaler I, Luder G, Damm U, Walti C, Steinheimer S, Verra ML, Muri RM, Nyffeler T, Vanbellingen T, Kamm CP. Standardized, comprehensive, hospital-based circuit training in people with multiple sclerosis: results on feasibility, adherence and satisfaction of the training intervention. Eur J Phys Rehabil Med. 2020 Jun;56(3):279-285. doi: 10.23736/S1973-9087.20.06191-2. Epub 2020 Mar 30.
PubMed 32225136
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardized Comprehensive Two-month Ambulatory Neurorehabilitation Program for Patients With Multiple Sclerosis: a Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT02440516
- Acronym / sponsor ID
- "MS-Fit" / 2015_04_29
- Conditions
- Multiple Sclerosis
- Keywords
- Standardized, Physical therapy, occupational therapy, quality of life, disability, activities of daily living, ambulatory therapy, multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 12 May 2015 (estimated)
- 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.
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. Despite increasing therapeutic options to ameliorate the disease course, most patients suffer from persistent neurological deficits over time.
Disability in MS has a negative impact on patients life's impairing activities of daily living (ADL) and quality of life (QoL) and leading to loss of work and the need providing care. This results in tremendous socioeconomic burden.
Disease-modifying treatments prevent disability progression in variable extent. However no drugs are available ameliorate persistent disability in MS. Therefore, exercise training as well as physical and occupational therapies are important in the symptomatic treatment of MS.
Physical and occupational therapy is usually performed close to patients home by therapist with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory neurorehabilitation program, integrating task oriented circuit training for MS patients to improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital settings.
Detailed description
Background
Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system (CNS) and the most common cause of non-traumatic disability in young adults in western countries. The incidence of MS is low in childhood and increases after the age of 18, reaching a peak between 20 and 40 years (mean age of 30 years) with women being affected approximately 2-5 years earlier than men. In Switzerland the incidence is thought to be 4:100.000 with approximately 12.500 affected patients.
Despite increasing therapeutic options to ameliorate the disease course, most patients suffer from persistent neurological deficits over time.
Neurologic symptoms can be manifold and are highly variable amongst patients. They include loss of vision, sensorimotor defects, impaired manual dexterity, ataxia, apraxia, gait disturbances, bladder- and bowl problems, fatigue, cognitive dysfunctions and others, which alone, or in combination, lead to disability in MS patients. Disability in MS has a negative impact on patients life's impairing activities of daily living (ADL) and quality of life (QoL) and leading to loss of work and the need providing care. This results in tremendous socioeconomic burden.
Disease-modifying treatments prevent disability progression in variable extent. However no drugs are available ameliorate persistent disability in MS. Therefore, exercise training as well as physical and occupational therapies are important in the symptomatic treatment of MS. Intensive task oriented circuit training has been shown to be effective in stroke improving gait, and several ADL. Some pilot randomized controlled trials in MS demonstrated exercise training being able to improve muscular strength, aerobic capacity and ambulatory performance as well as fatigue, balance and gait. Furthermore, specific therapies improve manual dexterity, coordination and mobilization in MS patients as well. Although, so far no randomized trial has been done to prove the effectiveness of task oriented circuit training in MS.
Physical and occupational therapy is usually performed close to patients home by therapist with different professional background in a non-standardized way.
The investigators therefore aim to develop a standardized comprehensive ambulatory neurorehabilitation program, integrating task oriented circuit training for MS patients to improve disability, ADL and QoL that can be easily adopted in other ambulatory or hospital settings.
Objective
To evaluate the impact of a standardized comprehensive ambulatory neurorehabilitation program on disability in patients with multiple sclerosis measured by performance based test of the upper and lower extremities and by patient recorded outcome measures regarding functioning of the upper and lower extremities, activities of daily living and quality of life.
The investigators hypothesize that this training program will improve disability, activities of daily living and quality of live in MS patients.
Methods
Prospective double center, randomized, cross-over study. Consecutive MS patients that complain about disability that affects ADL and/or QoL will be recruited to participate in a comprehensive ambulatory neurorehabilitation program. Afterwards baseline measurements will be performed and patients will be randomized 1:1 into the early treatment group or the delayed treatment group in groups of four using sealed envelopes. The early treatment group starts the neurorehabilitation program whereas in the delayed treatment group, patients will be put on a waiting list for two months. After two months, outcome measurements will be collected. Patients of the early treatment group stop the neurorehabilitation program and patients of the delayed treatment group start the neurorehabilitation program for two months ("cross-over design"). Two months after ending the program, each group will be retested.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurorehabilitation program | Active comparator | Other: Early treatment groupStandardized comprehensive ambulatory neurorehabilitation program |
| Waiting list | Placebo comparator | Other: Late treatment groupWaiting list |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS)
- Age between 18 and 75 years
- Written informed consent
- Patient complains about MS related disability that affects ADL and/or QoL
Key exclusion criteria (4 listed)
- A relapse that started within 60 days prior to screening
- Rapidly progressive disease
- Any disease/condition that causes neurological deficits or disability besides MS
- A history of drug abuse in the 12 months prior to screening
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 |
|---|---|---|
| Early treatment groupPhysical- and occupational Therapy | Other | Neurorehabilitation program |
| Late treatment groupWaiting list - then Physical- and occupational Therapy | Other | Waiting list |
Primary outcome
Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29)
Time frame: 2 - 4 months
The Multiple Sclerosis Impact Scale (MSIS-29) is valid and reliable (ICC 0.80 - 0.87) in measuring the impact of MS on ADL.It contains 29 items comprising to a physical (MSIS-29 physical) and psychological impact scale (MSIS-29 psychological). All items are scored from 'not at all' to 'extremely' on a five-point Likert scale.
7 secondary outcomes
Change from baseline in Coin Rotation Task (Heldner et al. 2014)
Time frame: 0 - 2 - 4 months
Change from baseline in Timed Up and Go (TUG) (Nilsagard et al. 2007)
Time frame: 0 - 2 - 4 months
Change from baseline in Nine-hole-Peg Test (NHPT) (Gookin et al. 1988)
Time frame: 0 - 2 - 4 months
Change from baseline in 25-Foot Walk Test (25-FWT) (Cohen et al. 2014)
Time frame: 0 - 2 - 4 months
Change from baseline in EDSS
Time frame: 0 - 2 - 4 months
Change from baseline in Rand 36
Time frame: 0 - 2 - 4 months
Change from baseline in Fatigue Severity Scale
Time frame: 0 - 2 - 4 months
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 1 Mar 2019.
- Background: PubMed 25095894Kamm CP, Uitdehaag BM, Polman CH. Multiple sclerosis: current knowledge and future outlook. Eur Neurol. 2014;72(3-4):132-41. doi: 10.1159/000360528. Epub 2014 Jul 30.
- Background: PubMed 16227547Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. How responsive is the Multiple Sclerosis Impact Scale (MSIS-29)? A comparison with some other self report scales. J Neurol Neurosurg Psychiatry. 2005 Nov;76(11):1539-43. doi: 10.1136/jnnp.2005.064584.
- Results publication: PubMed 22825702Motl RW, Pilutti LA. The benefits of exercise training in multiple sclerosis. Nat Rev Neurol. 2012 Sep;8(9):487-97. doi: 10.1038/nrneurol.2012.136. Epub 2012 Jul 24.
- Derived from this study: PubMed 32225136Lehmann I, Thaler I, Luder G, Damm U, Walti C, Steinheimer S, Verra ML, Muri RM, Nyffeler T, Vanbellingen T, Kamm CP. Standardized, comprehensive, hospital-based circuit training in people with multiple sclerosis: results on feasibility, adherence and satisfaction of the training intervention. Eur J Phys Rehabil Med. 2020 Jun;56(3):279-285. doi: 10.23736/S1973-9087.20.06191-2. Epub 2020 Mar 30.
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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.
Christian P Kamm, MD principal investigator
Department of Neurology, Cantonal hospital Luzern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early treatment group and Late treatment group in people with Multiple Sclerosis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 4 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 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in Multiple Sclerosis Impact Scale 29 (MSIS-29) (time frame: 2 - 4 months). 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 NCT02440516, which also lists 4 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 1 Mar 2019.