Multiple SclerosisNCT03187847
Rehabilitation in Multiple Sclerosis - Sometimes Too Much?
An observational study of Multiple Sclerosis, run by Klinik Valens at 1 site in Switzerland.
Trial summary
The primary objective is to evaluate changes in fatigue and physical activity (step counts) before and after rehabilitation in patients with MS (EDSS 3-6.5). The association of changes in fatigue and physical activity will also be analyzed for disease severity (EDSS), age, emotional status (depression) of the… 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?
- Actigraph GT3X
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Aug 2017to 4 Jun 2018
- Phase
- Observational
- 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
Study population: The investigator plans to include at least 20 patients with multiple sclerosis with an EDSS 3-6.5, who come to Valens for rehabilitation from the end of August 2017 until July 2018.
Who may be able to join
- EDSS 3-6.5, an EDSS 6.5 means the ability to walk 20 meters without resting, using constant bilateral assistance
- >18 years old
- German speaking
- good function of the upper extremity to put on Actigraph by themselves
- participants should be able to wear the Actigraph at least 6h/day for 7 days
Who cannot join
- inability to follow the instructions given, e.g. language problems, psychological disorders
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Perceived Fatigue and Step Counts Before and After Rehabilitation. A Prospective, Single-center, Longitudinal Observational Study.
The primary objective is to evaluate changes in fatigue and physical activity (step counts) before and after rehabilitation in patients with MS (EDSS 3-6.5).
The association of changes in fatigue and physical activity will also be analyzed for disease severity (EDSS), age, emotional status (depression) of the participants.
Read the detailed description
Around 2 million people worldwide have multiple sclerosis (MS) and it is the most common neurological disease in young adults. The greatest incidence of MS is found in Europe (108 per 100'000). Over 50% of the patients with MS suffer from fatigue and reduced physical activity. The association between inactivity and fatigue is low in patients with mild disability.
Rehabilitation in Valens includes intensive strength and endurance training. Endurance and walking improve in most patients, evaluated during rehabilitation with the Timed-Up and Go (TUG) and 2 minute walking tests (2MWT). However, Clinic Valens occasionally gets feedback from physical therapists in the ambulatory setting, that outcome after rehabilitation is sometimes poor and some patients with MS (pwMS) seem to be over trained, less mobile, more fatigued and need to recover for several weeks. Physical therapists in Valens know that training is fatiguing. If they knew how many, and which patients are more fatigued and less active after rehabilitation they could reduce treatment intensity and prevent overtraining.
To the knowledge of the investigators no study evaluated changes after rehabilitation in fatigue, assessed with a disease specific questionnaire (FSMC), and mobility at home using accelerometers. Potential predictors of poor outcome are disease severity (EDSS), pre-rehabilitation fatigue and depression.
The primary goal of this study therefore is to evaluate changes in fatigue and physical activity (step counts) in pwMS assessed before rehabilitation, after rehabilitation and at 2 months follow-up.
- Conditions
- Multiple Sclerosis
- Being tested
- Actigraph GT3X
- Keywords
- Physical Activity, Fatigue, Rehabilitation
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actigraph GT3XDevice
Also called FSMC, HADS
The primary outcomes are measured by the Actigraph GT3X (step counts) and FSMC (fatigue scale for motor and cognitive functions questionnaire) at three different points in time (Actigraph is worn for three weeks in total).
The secondary outcomes are emotional status, measured by the hospital anxiety and depression scale (HADS) and quality of life, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS).
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fatigue
The primary objective is to evaluate changes in fatigue before and after rehabilitation in patients with MS (EDSS 3-6.5). Fatigue will be assessed with the FSMC questionnaire at three different time points.
Measured: Fatigue will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.
Changes in Physical Activity/Step Counts (Actigraph GT3X)
The primary objective is to evaluate changes in physical activity (steps per day) before and after rehabilitation in patients with MS (EDSS 3-6.5). This will be measured by the Actigraph GT3X at three different time points.
Measured: The Actigraph device will be worn for three weeks in total. Before rehabilitation (whle participants are still at home), the week right after rehabilitation and at 2 months follow up.
Secondary outcomes (2)
quality of life in association with changes in fatigue and physical activity
The association of changes in fatigue and physical activity will also be analyzed for quality of life of the participants. This will be measured by the Hamburg Quality of Life Questionnaire (HAQUAMS) at three different time points.
Measured: The quality of life will be assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.
emotional status (depression) in association with changes in fatigue and physical activity
The association of changes in fatigue and physical activity will also be analyzed for the emotional status of the participants. This will be measured by the hospital anxiety and depression scale (HADS) at three different time points.
Measured: The emotional status will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start27 Aug 2017
- Primary completion30 Mar 2018
- Study completion4 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kündig, Klinik Valens
- Investigators
- Sandra Kündig, BSc, Principal investigator, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187847
- Sponsor's protocol ID
- 2017-00728
- Other IDs
- 2017
- Status last verified
- Jun 2018
- First submitted
- 28 May 2017
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kingwell E, Marriott JJ, Jette N, Pringsheim T, Makhani N, Morrow SA, Fisk JD, Evans C, Beland SG, Kulaga S, Dykeman J, Wolfson C, Koch MW, Marrie RA. Incidence and prevalence of multiple sclerosis in Europe: a systematic review. BMC Neurol. 2013 Sep 26;13:128. doi: 10.1186/1471-2377-13-128.
PubMed 24070256Rietberg MB, van Wegen EE, Uitdehaag BM, Kwakkel G. The association between perceived fatigue and actual level of physical activity in multiple sclerosis. Mult Scler. 2011 Oct;17(10):1231-7. doi: 10.1177/1352458511407102. Epub 2011 May 17.
PubMed 21586484
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Perceived Fatigue and Step Counts Before and After Rehabilitation. A Prospective, Single-center, Longitudinal Observational Study.
- ClinicalTrials.gov ID
- NCT03187847
- Acronym / sponsor ID
- 2017-00728
- Conditions
- Multiple Sclerosis
- Keywords
- Physical Activity, Fatigue, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Study start
- 27 Aug 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 4 Jun 2018 (actual)
- First posted
- 15 Jun 2017 (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.
The primary objective is to evaluate changes in fatigue and physical activity (step counts) before and after rehabilitation in patients with MS (EDSS 3-6.5).
The association of changes in fatigue and physical activity will also be analyzed for disease severity (EDSS), age, emotional status (depression) of the participants.
Detailed description
Around 2 million people worldwide have multiple sclerosis (MS) and it is the most common neurological disease in young adults. The greatest incidence of MS is found in Europe (108 per 100'000). Over 50% of the patients with MS suffer from fatigue and reduced physical activity. The association between inactivity and fatigue is low in patients with mild disability.
Rehabilitation in Valens includes intensive strength and endurance training. Endurance and walking improve in most patients, evaluated during rehabilitation with the Timed-Up and Go (TUG) and 2 minute walking tests (2MWT). However, Clinic Valens occasionally gets feedback from physical therapists in the ambulatory setting, that outcome after rehabilitation is sometimes poor and some patients with MS (pwMS) seem to be over trained, less mobile, more fatigued and need to recover for several weeks. Physical therapists in Valens know that training is fatiguing. If they knew how many, and which patients are more fatigued and less active after rehabilitation they could reduce treatment intensity and prevent overtraining.
To the knowledge of the investigators no study evaluated changes after rehabilitation in fatigue, assessed with a disease specific questionnaire (FSMC), and mobility at home using accelerometers. Potential predictors of poor outcome are disease severity (EDSS), pre-rehabilitation fatigue and depression.
The primary goal of this study therefore is to evaluate changes in fatigue and physical activity (step counts) in pwMS assessed before rehabilitation, after rehabilitation and at 2 months follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigator plans to include at least 20 patients with multiple sclerosis with an EDSS 3-6.5, who come to Valens for rehabilitation from the end of August 2017 until July 2018.
Key inclusion criteria (5 listed)
- EDSS 3-6.5, an EDSS 6.5 means the ability to walk 20 meters without resting, using constant bilateral assistance
- >18 years old
- German speaking
- good function of the upper extremity to put on Actigraph by themselves
- participants should be able to wear the Actigraph at least 6h/day for 7 days
Key exclusion criteria (2 listed)
- inability to follow the instructions given, e.g. language problems, psychological disorders
- no informed consent
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 |
|---|---|---|
| Actigraph GT3XAlso: FSMC, HADSThe primary outcomes are measured by the Actigraph GT3X (step counts) and FSMC (fatigue scale for motor and cognitive functions questionnaire) at three different points in time (Actigraph is worn for three weeks in total). The secondary outcomes are emotional status, measured by the hospital anxiety and depression scale (HADS) and quality of life, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS). | Device | – |
Primary outcome
Changes in Fatigue
Time frame: Fatigue will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.
The primary objective is to evaluate changes in fatigue before and after rehabilitation in patients with MS (EDSS 3-6.5). Fatigue will be assessed with the FSMC questionnaire at three different time points.
Changes in Physical Activity/Step Counts (Actigraph GT3X)
Time frame: The Actigraph device will be worn for three weeks in total. Before rehabilitation (whle participants are still at home), the week right after rehabilitation and at 2 months follow up.
The primary objective is to evaluate changes in physical activity (steps per day) before and after rehabilitation in patients with MS (EDSS 3-6.5). This will be measured by the Actigraph GT3X at three different time points.
2 secondary outcomes
quality of life in association with changes in fatigue and physical activity
Time frame: The quality of life will be assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.
emotional status (depression) in association with changes in fatigue and physical activity
Time frame: The emotional status will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.
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 12 Jun 2018.
- Background: PubMed 24070256Kingwell E, Marriott JJ, Jette N, Pringsheim T, Makhani N, Morrow SA, Fisk JD, Evans C, Beland SG, Kulaga S, Dykeman J, Wolfson C, Koch MW, Marrie RA. Incidence and prevalence of multiple sclerosis in Europe: a systematic review. BMC Neurol. 2013 Sep 26;13:128. doi: 10.1186/1471-2377-13-128.
- Background: PubMed 21586484Rietberg MB, van Wegen EE, Uitdehaag BM, Kwakkel G. The association between perceived fatigue and actual level of physical activity in multiple sclerosis. Mult Scler. 2011 Oct;17(10):1231-7. doi: 10.1177/1352458511407102. Epub 2011 May 17.
- The Atlas of MS 2013 reportLink provided by the sponsor.
- 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.
Sandra Kündig, BSc principal investigator
Klinik Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Klinik Valens at 1 site 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 5 inclusion and 2 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 12 Jun 2018. 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 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. 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?
Changes in Fatigue (time frame: Fatigue will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant.). 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 NCT03187847, which also lists 2 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 12 Jun 2018; AzTrials last refreshed its copy on 29 Oct 2026.