Multiple SclerosisNCT00381576
Multiple Sclerosis and Heavy Progressive Resistance Training
A study testing Resistance training in people with Multiple Sclerosis, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The purpose of the present investigation is to determine whether MS patients can tolerate and benefit from heavy progressive resistance training. A second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training. 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?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- Nov 2006to Jun 2008
- 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
- Clinical diagnosis of Relapsing Remitting Multiple Sclerosis according to the McDonald criteria
- Expanded Disability Status Scale Score between 3,0-5,5
- Be able to walk at least 100m
- Be able to train twice a week at the University
Who cannot join
- Alcohol abuse, Alzheimer's and pacemaker
- Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
- Having had an attack in a period of 8 weeks prior to the start of the intervention period
- Having an attack during the intervention period
- Pregnancy
- Systematic resistance training in a period of 3 months prior to the start of the intervention period.
- Training adherence of less than 85%.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
MS Clinic, Department of Neurology, Aarhus University Hospital
Aarhus, 8000
Department of Sports Science, University of Aarhus
Aarhus, 8200
About this study
Official title: Multiple Sclerosis and Muscle Function - Effects of Heavy Progressive Resistance Training
The purpose of the present investigation is to determine whether MS patients can tolerate and benefit from heavy progressive resistance training. A second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training.
Read the detailed description
Multiple sclerosis (MS) patients are characterized by reduced muscle strength and functional capacity. For MS patients, improvements in muscle strength and thereby functional capacity, would have the potential to make both the daily living easier and to extend the time living independently. Attempts to improve muscle strength and function include the application of physical training, although the general advice to MS patients for many years has been to avoid participation in physical training. It has now been demonstrated that endurance training at low to moderate intensity is well tolerated by MS patients, but it only induces modest improvements in both muscle strength and functional capacity. Heavy progressive resistance training (HPRT) has proven to be the most effective means to improve muscle strength and functional capacity during daily activities in healthy older people. However, the effects of HPRT have not been investigated in randomised control trials in MS patients.
- Conditions
- Multiple Sclerosis
- Being tested
- Resistance training
- Keywords
- Resistance training, Strength training, Training adaptations, CNS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Intervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 12 weeks of resistance training Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength (isokinetic testing)
Measured: Before and after the intervention
Secondary outcomes (8)
Functional capacity (Six minute walk test, 10m walk test, chair rise, stair climbing)
Measured: Before and after the intervention
Muscle biopsies from m. vastus lateralis
Measured: Before and after the intervention
% Fat (skinfold)
Measured: Before and after the intervention
Blood samples (immunologic parameters)
Measured: Before and after the intervention
Fatigue (Fatigue Severity Scale - FSS, Modified Fatigue Inventory - MFI-20)
Measured: Before and after the intervention
HRQOL: SF36
Measured: Before and after the intervention
Depression: Major Depression Inventory (MDI)
Measured: Before and after the intervention
Surface EMG from m. vastus lateralis during MVC
Measured: Before and after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2008
- Study completionJun 2008
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Sonderborg Hospital, The Danish Multiple Sclerosis Society
- Investigators
- Ulrik Dalgas, Ph.d. Stud., Principal investigator, Department of Sports Science, University of AarhusThorsten Ingemann-Hansen, Professor, Study chair, Department of Sports Science, University of AarhusEgon Stenager, MD, Study chair, MS clinic, Department of Neurology, Sonderborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381576
- Sponsor's protocol ID
- 300976
- Status last verified
- Aug 2008
- First submitted
- 27 Sep 2006
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dalgas U, Stenager E, Lund C, Rasmussen C, Petersen T, Sorensen H, Ingemann-Hansen T, Overgaard K. Neural drive increases following resistance training in patients with multiple sclerosis. J Neurol. 2013 Jul;260(7):1822-32. doi: 10.1007/s00415-013-6884-4. Epub 2013 Mar 13.
PubMed 23483214Dalgas U, Severinsen K, Overgaard K. Relations between 6 minute walking distance and 10 meter walking speed in patients with multiple sclerosis and stroke. Arch Phys Med Rehabil. 2012 Jul;93(7):1167-72. doi: 10.1016/j.apmr.2012.02.026. Epub 2012 Mar 12.
PubMed 22421626
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple Sclerosis and Muscle Function - Effects of Heavy Progressive Resistance Training
- ClinicalTrials.gov ID
- NCT00381576
- Acronym / sponsor ID
- 300976
- Conditions
- Multiple Sclerosis
- Keywords
- Resistance training, Strength training, Training adaptations, CNS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Sonderborg Hospital, The Danish Multiple Sclerosis Society
- Study start
- Nov 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 28 Sep 2006 (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.
The purpose of the present investigation is to determine whether MS patients can tolerate and benefit from heavy progressive resistance training. A second purpose is to determine both neural and muscle morphological adaptations to heavy progressive resistance training.
Detailed description
Multiple sclerosis (MS) patients are characterized by reduced muscle strength and functional capacity. For MS patients, improvements in muscle strength and thereby functional capacity, would have the potential to make both the daily living easier and to extend the time living independently. Attempts to improve muscle strength and function include the application of physical training, although the general advice to MS patients for many years has been to avoid participation in physical training. It has now been demonstrated that endurance training at low to moderate intensity is well tolerated by MS patients, but it only induces modest improvements in both muscle strength and functional capacity. Heavy progressive resistance training (HPRT) has proven to be the most effective means to improve muscle strength and functional capacity during daily activities in healthy older people. However, the effects of HPRT have not been investigated in randomised control trials in MS patients.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Resistance training12 weeks of resistance 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)
- Clinical diagnosis of Relapsing Remitting Multiple Sclerosis according to the McDonald criteria
- Expanded Disability Status Scale Score between 3,0-5,5
- Be able to walk at least 100m
- Be able to train twice a week at the University
Key exclusion criteria (7 listed)
- Alcohol abuse, Alzheimer's and pacemaker
- Comorbidities like cardiovascular-, respiratory-, orthopaedic or metabolic diseases
- Having had an attack in a period of 8 weeks prior to the start of the intervention period
- Having an attack during the intervention period
- Pregnancy
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 |
|---|---|---|
| Resistance trainingIntervention group: 12 weeks of resistance training for the lower extremity. Control group: No intervention - 12 weeks of normal daily living | Behavioural | A |
Primary outcome
Muscle strength (isokinetic testing)
Time frame: Before and after the intervention
8 secondary outcomes
Functional capacity (Six minute walk test, 10m walk test, chair rise, stair climbing)
Time frame: Before and after the intervention
Muscle biopsies from m. vastus lateralis
Time frame: Before and after the intervention
% Fat (skinfold)
Time frame: Before and after the intervention
Blood samples (immunologic parameters)
Time frame: Before and after the intervention
Fatigue (Fatigue Severity Scale - FSS, Modified Fatigue Inventory - MFI-20)
Time frame: Before and after the intervention
HRQOL: SF36
Time frame: Before and after the intervention
Depression: Major Depression Inventory (MDI)
Time frame: Before and after the intervention
Surface EMG from m. vastus lateralis during MVC
Time frame: Before and after the intervention
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 Aug 2008.
- Derived from this study: PubMed 23483214Dalgas U, Stenager E, Lund C, Rasmussen C, Petersen T, Sorensen H, Ingemann-Hansen T, Overgaard K. Neural drive increases following resistance training in patients with multiple sclerosis. J Neurol. 2013 Jul;260(7):1822-32. doi: 10.1007/s00415-013-6884-4. Epub 2013 Mar 13.
- Derived from this study: PubMed 22421626Dalgas U, Severinsen K, Overgaard K. Relations between 6 minute walking distance and 10 meter walking speed in patients with multiple sclerosis and stroke. Arch Phys Med Rehabil. 2012 Jul;93(7):1167-72. doi: 10.1016/j.apmr.2012.02.026. Epub 2012 Mar 12.
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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, Ph.d. Stud. principal investigator
Department of Sports Science, University of Aarhus
Thorsten Ingemann-Hansen, Professor study chair
Department of Sports Science, University of Aarhus
Egon Stenager, MD study chair
MS clinic, Department of Neurology, Sonderborg Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Multiple Sclerosis, run by University of Aarhus at 2 sites 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 4 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 12 Aug 2008. 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 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.
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?
Muscle strength (isokinetic testing) (time frame: Before and after the intervention). 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 NCT00381576, 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 Aug 2008.