Multiple SclerosisPhase 1NCT01752660
Exercise in Severely Disabled Patients With MS
A Phase 1 study testing Endurance training in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. 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?
- Endurance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2012to Jul 2013
- Phase
- Phase 1
- 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
- Signed informed consent
- ->18 years
- Primary progressive or secondary progressive MS according to the McDonald criteria
- 6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
- Maximal walking distance ≤ 10m
Who cannot join
- Patients are excluded if they:
- have dementia,alcoholism, or pacemaker treatment
- any serious medical comorbidities
- are pregnant
- have done systematic endurance training (>1day/week) within the last 3 months.
- complete less than 80% of the planned training sessions
- medical conditions that exclude performance of a maximal endurance test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endurance Training in Severely Disabled Patients With MS - a Feasibility Study
In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS.
Read the detailed description
For many years, patients with multiple sclerosis (MS) have been advised not to participate in physical exercise. This advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. A further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. During the last decade, it has been more common to recommend exercise for MS patients, because of its recently proven beneficial effects in these patients.
Resistance- and endurance training constitutes the two extremes of basic physical exercise. To gain insight into the effects of exercise it therefore makes sense to understand the extremes. In mild to moderately impaired MS patients endurance training is well tolerated and providing beneficial effects. However, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. The investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled MS patients (Expanded Disability Status Scale score > 6).
Patients are inpatients at one of the national MS hospitals and endurance training is added to the usual care, and compared to usual care only (control group). Exercise frequency is 3 times per week, and intensity is controlled by HR measurements during exercise.
- Conditions
- Multiple Sclerosis
- Being tested
- Endurance training, Standard care
- Keywords
- Exercise therapy, Aerobic training, Endurance training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurance trainingBehavioural
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity.
Standard careBehavioural
Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.
| Study group | Role | What they receive |
|---|---|---|
| Endurance training | Experimental | Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity. Receives: Behavioral: Endurance training; Behavioral: Standard care |
| Standard care | Active comparator | Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise compliance
Compliance to exercise is registered and serve as the primary outcome.
Measured: Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention
Drop out rate
Measured: Number of participants who drop out is registered at the post measurement just after the intervention.
Secondary outcomes (5)
Peak oxygen consumption
Measurement of peak oxygen consumption during a ramp protocol on armergometer.
Measured: 1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured
Box and Block test
Measured: 1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed
Sit to stand test
Measured: 1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed
Handgrip test
Measured: 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed
Wheel-chair test
Measured: 1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University of AarhusThe 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish MS Society, Danish MS Hospitals, Haslev and Ry, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Ulrik Dalgas, PhD, Principal investigator, Dep. Public Health, Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752660
- Sponsor's protocol ID
- UAarhus100
- Status last verified
- Jul 2013
- First submitted
- 12 Nov 2012
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Skjerbaek AG, Naesby M, Lutzen K, Moller AB, Jensen E, Lamers I, Stenager E, Dalgas U. Endurance training is feasible in severely disabled patients with progressive multiple sclerosis. Mult Scler. 2014 Apr;20(5):627-30. doi: 10.1177/1352458513505351. Epub 2013 Sep 20.
PubMed 24057428
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endurance Training in Severely Disabled Patients With MS - a Feasibility Study
- ClinicalTrials.gov ID
- NCT01752660
- Acronym / sponsor ID
- UAarhus100
- Conditions
- Multiple Sclerosis
- Keywords
- Exercise therapy, Aerobic training, Endurance training
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish MS Society, Danish MS Hospitals, Haslev and Ry, Aarhus University Hospital
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 Dec 2012 (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.
In the last decade physical exercise has become an accepted and integrated part of rehabilitation in patients with multiple sclerosis (MS). However, no studies have evaluated whether the most severely disabled patients can tolerate and benefit from exercise therapy. The purpose of this study is therefore to evaluate the feasibility of endurance training in severely disabled patients with MS.
Detailed description
For many years, patients with multiple sclerosis (MS) have been advised not to participate in physical exercise. This advice was given in part because some patients were reported to experience symptom instability during exercise as a consequence of increased body temperature. A further argument was that avoiding exercise would preserve energy and thereby result in less fatigue, leaving more energy for activities of daily living. During the last decade, it has been more common to recommend exercise for MS patients, because of its recently proven beneficial effects in these patients.
Resistance- and endurance training constitutes the two extremes of basic physical exercise. To gain insight into the effects of exercise it therefore makes sense to understand the extremes. In mild to moderately impaired MS patients endurance training is well tolerated and providing beneficial effects. However, this exercise modality has not yet been tested in severely disabled patients, and it is therefore unclear if endurance training is feasible and beneficial in these patients. The investigators have, therefore, designed a feasibility study evaluating the effects of 4 weeks of endurance training in severely disabled MS patients (Expanded Disability Status Scale score > 6).
Patients are inpatients at one of the national MS hospitals and endurance training is added to the usual care, and compared to usual care only (control group). Exercise frequency is 3 times per week, and intensity is controlled by HR measurements during exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance training | Experimental | Behavioral: Endurance training, Behavioral: Standard careStandard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity. |
| Standard care | Active comparator | Behavioral: Standard careStandard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- ->18 years
- Primary progressive or secondary progressive MS according to the McDonald criteria
- 6.5 ≤ EDSS ≤ 8.0 and pyramidal score between 1 and 4
- Maximal walking distance ≤ 10m
Key exclusion criteria (7 listed)
- Patients are excluded if they:
- have dementia,alcoholism, or pacemaker treatment
- any serious medical comorbidities
- are pregnant
- have done systematic endurance training (>1day/week) within the last 3 months.
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 |
|---|---|---|
| Endurance trainingStandard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity. | Behavioural | Endurance training |
| Standard careStandard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center. | Behavioural | Endurance training, Standard care |
Primary outcome
Exercise compliance
Time frame: Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention
Compliance to exercise is registered and serve as the primary outcome.
Drop out rate
Time frame: Number of participants who drop out is registered at the post measurement just after the intervention.
5 secondary outcomes
Peak oxygen consumption
Time frame: 1-2 day before the intervention and 1-2days after the 4 week intervention peak oxygen is measured
Box and Block test
Time frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the box and block test is performed
Sit to stand test
Time frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the sit to stand test is performed
Handgrip test
Time frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the handgrip test is performed
Wheel-chair test
Time frame: 1-2 day before the intervention and 1-2days after the 4 week intervention the wheel-chair test is performed
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 18 Jul 2013.
- Derived from this study: PubMed 24057428Skjerbaek AG, Naesby M, Lutzen K, Moller AB, Jensen E, Lamers I, Stenager E, Dalgas U. Endurance training is feasible in severely disabled patients with progressive multiple sclerosis. Mult Scler. 2014 Apr;20(5):627-30. doi: 10.1177/1352458513505351. Epub 2013 Sep 20.
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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.
Ulrik Dalgas, PhD principal investigator
Dep. Public Health, Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endurance training in people with Multiple Sclerosis, run by University of Aarhus at 1 site in Denmark.
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 7 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 18 Jul 2013. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Exercise compliance (time frame: Exercise compliance is registered immediatly after all planned exercise sessions during the 4 week intervention). 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 NCT01752660, which also lists 1 linked publication.
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 18 Jul 2013.