Multiple SclerosisNCT06505421
Eccentric Exercise and Fatigue in Multiple Sclerosis
An observational study of Multiple Sclerosis and Fatigue, run by Hunter College of City University of New York at 1 site in United States.
Trial summary
The goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Ambulatory persons with MS
Who may be able to join
- Definitive diagnosis of Multiple Sclerosis.
- Ability to walk for 6 minutes continuously with or without assistive device
- Ability read, understand and sign and informed consent
Who cannot join
- Evidence of recent exacerbation in the last 2 months prior to starting the study
- Orthopedic, cardiopulmonary, or non -MS neurologic condition that could interfere with carrying out the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hunter College, Physical Therapy Department, City University of New York
New York, New York, 10010
Herbert Karpatkin, DSc, 212-396-7115, hkarpatk@hunter.cuny.edu
About this study
Official title: The Effect of Lower Extremity Eccentric Resistance Training on Fatigue in Multiple Sclerosis
The goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: is eccentric resistance training more fatiguing than traditional resistance training in persons with MS?. Participants will be asked to come for two sessions for two weeks. In the first week, subjects will undergo a bout of either traditional or eccentric resistance training. The next day they will return to assess their level of fatigue. The following week the subject will return and undergo whatever type of training they did not experience the first week, and it's effects on fatigue will again be assessed. The difference between the subjects level of fatigue for either condition will be compared.
Read the detailed description
Persons with multiple sclerosis (MS) have mobility deficits. Exercise is commonly used to treat these mobility deficits, but must be done so judiciously in order to limit the effects of fatigue, one of the most common disease findings. In persons with MS ,fatigue can limit the amount of exercise performed. Eccentric training, where a muscle is lengthened under resistance has been shown to produce greater gains in strength with less energy expenditure when compared to traditional strength training where a muscle is both lengthened and shortened under resistance. However, eccentric strength training has been shown to result in delayed onset muscle soreness, which may also limit how much exercise a person with MS can perform. The purpose of the study is to compare the impact of eccentric versus traditional strength training programs on fatigue and persons with multiple sclerosis. The hypothesis is that there will be no difference in fatigue measurements between the two conditions. If the hypothesis is correct, it will suggest that eccentric training should be the subject of further study to assess it's feasibility and effectiveness, in treating mobility deficits in person with multiple sclerosis.
A randomized crossover design will be used. Ambulatory participants with a diagnosis of MS will be randomized into either a eccentric or traditional training condition. Each training condition will consist of a single session of training. The following day, the patient will return and their levels of fatigue assessed. The next week, the subjects will return and crossover, undergoing whatever type of training they did not experience in the previous week, and the impact of the training will again be assessed.
- Conditions
- Multiple Sclerosis, Fatigue
- Being tested
- Resistance training
- Keywords
- Exercise, resistance training
- Medical subject headings
- Multiple Sclerosis, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Eccentric resistance training and tradional resistance training
| Study group | Role | What they receive |
|---|---|---|
| Persons with Multiple sclerosis | Eccentric resistance training , traditional resistance training Receives: Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute walk test
Subject walks at best possible pace with or without assistive device for 6 minutes. Total distance walked as well as distance per minute is measured
Measured: Pre-intervention and post intervention for each condition (eccentric and traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition
Secondary outcomes (1)
Visual analog scale of fatigue
Immediately before and after each 6 minute walk subjects will make a mark on a 100mm line indicating their level of fatigue
Measured: Pre-intervention and post-intervention for each condition (eccentric vs traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herb Karpatkin, City University of New York, School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505421
- Sponsor's protocol ID
- 20240244
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patrocinio de Oliveira CE, Moreira OC, Carrion-Yagual ZM, Medina-Perez C, de Paz JA. Effects of Classic Progressive Resistance Training Versus Eccentric-Enhanced Resistance Training in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 May;99(5):819-825. doi: 10.1016/j.apmr.2017.10.021. Epub 2017 Nov 27.
PubMed 29191417Wochatz M, Schraplau A, Engel T, Zecher MM, Sharon H, Alt Y, Mayer F, Kalron A. Application of eccentric training in various clinical populations: Protocol for a multi-centered pilot and feasibility study in people with low back pain and people with multiple sclerosis. PLoS One. 2022 Dec 22;17(12):e0270875. doi: 10.1371/journal.pone.0270875. eCollection 2022.
PubMed 36548298Gauche E, Couturier A, Lepers R, Michaut A, Rabita G, Hausswirth C. Neuromuscular fatigue following high versus low-intensity eccentric exercise of biceps brachii muscle. J Electromyogr Kinesiol. 2009 Dec;19(6):e481-6. doi: 10.1016/j.jelekin.2009.01.006. Epub 2009 Feb 12.
PubMed 19217311
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lower Extremity Eccentric Resistance Training on Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06505421
- Acronym / sponsor ID
- 20240244
- Conditions
- Multiple Sclerosis, Fatigue
- Keywords
- Exercise, resistance training
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 17 Jul 2024 (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 goal of this observational study is to compare the impact of eccentric resistance training to traditional resistance training on fatigue in persons with multiple sclerosis (MS). The primary question this study is asking is the following: is eccentric resistance training more fatiguing than traditional resistance training in persons with MS?. Participants will be asked to come for two sessions for two weeks. In the first week, subjects will undergo a bout of either traditional or eccentric resistance training. The next day they will return to assess their level of fatigue. The following week the subject will return and undergo whatever type of training they did not experience the first week, and it's effects on fatigue will again be assessed. The difference between the subjects level of fatigue for either condition will be compared.
Detailed description
Persons with multiple sclerosis (MS) have mobility deficits. Exercise is commonly used to treat these mobility deficits, but must be done so judiciously in order to limit the effects of fatigue, one of the most common disease findings. In persons with MS ,fatigue can limit the amount of exercise performed. Eccentric training, where a muscle is lengthened under resistance has been shown to produce greater gains in strength with less energy expenditure when compared to traditional strength training where a muscle is both lengthened and shortened under resistance. However, eccentric strength training has been shown to result in delayed onset muscle soreness, which may also limit how much exercise a person with MS can perform. The purpose of the study is to compare the impact of eccentric versus traditional strength training programs on fatigue and persons with multiple sclerosis. The hypothesis is that there will be no difference in fatigue measurements between the two conditions. If the hypothesis is correct, it will suggest that eccentric training should be the subject of further study to assess it's feasibility and effectiveness, in treating mobility deficits in person with multiple sclerosis.
A randomized crossover design will be used. Ambulatory participants with a diagnosis of MS will be randomized into either a eccentric or traditional training condition. Each training condition will consist of a single session of training. The following day, the patient will return and their levels of fatigue assessed. The next week, the subjects will return and crossover, undergoing whatever type of training they did not experience in the previous week, and the impact of the training will again be assessed.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons with Multiple sclerosis | – | Behavioral: Resistance trainingEccentric resistance training , traditional resistance training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Ambulatory persons with MS
Key inclusion criteria (3 listed)
- Definitive diagnosis of Multiple Sclerosis.
- Ability to walk for 6 minutes continuously with or without assistive device
- Ability read, understand and sign and informed consent
Key exclusion criteria (2 listed)
- Evidence of recent exacerbation in the last 2 months prior to starting the study
- Orthopedic, cardiopulmonary, or non -MS neurologic condition that could interfere with carrying out the study protocol
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 trainingEccentric resistance training and tradional resistance training | Behavioural | Persons with Multiple sclerosis |
Primary outcome
6-Minute walk test
Time frame: Pre-intervention and post intervention for each condition (eccentric and traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition
Subject walks at best possible pace with or without assistive device for 6 minutes. Total distance walked as well as distance per minute is measured
1 secondary outcome
Visual analog scale of fatigue
Time frame: Pre-intervention and post-intervention for each condition (eccentric vs traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 29191417Patrocinio de Oliveira CE, Moreira OC, Carrion-Yagual ZM, Medina-Perez C, de Paz JA. Effects of Classic Progressive Resistance Training Versus Eccentric-Enhanced Resistance Training in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 May;99(5):819-825. doi: 10.1016/j.apmr.2017.10.021. Epub 2017 Nov 27.
- Background: PubMed 36548298Wochatz M, Schraplau A, Engel T, Zecher MM, Sharon H, Alt Y, Mayer F, Kalron A. Application of eccentric training in various clinical populations: Protocol for a multi-centered pilot and feasibility study in people with low back pain and people with multiple sclerosis. PLoS One. 2022 Dec 22;17(12):e0270875. doi: 10.1371/journal.pone.0270875. eCollection 2022.
- Background: PubMed 19217311Gauche E, Couturier A, Lepers R, Michaut A, Rabita G, Hausswirth C. Neuromuscular fatigue following high versus low-intensity eccentric exercise of biceps brachii muscle. J Electromyogr Kinesiol. 2009 Dec;19(6):e481-6. doi: 10.1016/j.jelekin.2009.01.006. Epub 2009 Feb 12.
- 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.
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 and Fatigue, run by Hunter College of City University of New York at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Jul 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Herbert Karpatkin, DSc (212-396-7115, hkarpatk@hunter.cuny.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute walk test (time frame: Pre-intervention and post intervention for each condition (eccentric and traditional strength training). There is a 36-48 hour period between the pre-intervention and post intervention for each condition). 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 NCT06505421, which also lists 3 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 17 Jul 2024.