Multiple SclerosisNCT04853654
Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis
A study testing exercise in people with Multiple Sclerosis and Exercise, run by Sanko University at 1 site in Turkey (Türkiye).
Trial summary
Selective exercise programs specific to muscle groups, with the workload to be done in line with the muscle's own structure, can enable more strength to be released with less fatigue in MS, and this increase in strength can increase balance and functional activities. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Exercise
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 15 Jun 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18-50,
- With an Extended Disability Status Scale (EDSS) score of 4 or less,
- No regular exercise habit
- Able to walk on the treadmill,
- No pregnancy,
- Not receiving corticosteroid treatment in the last month,
- Fampridine etc. in the last 1 month. not taking medication,
- Patients who have not received Botox treatment in the last 6 months
Who cannot join
- patients who do not agree to volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Selective Exercise Training on Muscle Architecture, Balance, Function and Fatigue in Multiple Sclerosis
Selective exercise programs specific to muscle groups, with the workload to be done in line with the muscle's own structure, can enable more strength to be released with less fatigue in MS, and this increase in strength can increase balance and functional activities. to determine the effects of type training (selective exercise training), eccentric and concentric training on function, balance, fatigue and muscle architecture.
Read the detailed description
Recovery and enhancement of muscle function in MS is one of the main goals in physiotherapy and rehabilitation. In literature studies, it is stated that eccentric and concentric exercises are effective exercise approaches in increasing strength and reducing fatigue. However, the best exercise method is not yet clear in terms of providing better performance adaptation with less fatigue. Considering the architectural features of the lower extremity muscles, it is aimed to increase the angle of pennation with programs that include concentric strengthening of the quadriceps, gastro-soleus and gastrocnemius muscles, which are suitable muscle groups to produce large forces by design. With programs that include eccentric strengthening of the hamstring and tibialis anterior muscles that function in a wide range of motion and have high excursion ability, it is aimed to increase fiber length.
- Conditions
- Multiple Sclerosis, Exercise
- Being tested
- exercise
- Keywords
- multiple sclerosis, muscle architecture, Eccentric Exercise, Concentric Exercise
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
exercise training for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Selective training | Experimental | selective training on lower extremity for 3 days/week Receives: Other: exercise |
| Downhill walking | Experimental | downhill walking training on the treadmill for 2 days/week Receives: Other: exercise |
| Uphill walking | Experimental | uphill walking training on the treadmill for 2 days/week Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle architecture parameter 1
The pennation angle were evaluated with Ultrasound
Measured: Change from Baseline at 8th weeks and 12th weeks
muscle architecture parameter 2
The fiber length were evaluated with Ultrasound
Measured: Change from Baseline at 8th weeks and 12th weeks
muscle architecture parameter 3
The muscle thickness were evaluated with Ultrasound
Measured: Change from Baseline at 8th weeks and 12th weeks
Muscle strength
low extremity muscles were evaluated with hand dynamometer
Measured: Change from Baseline at 8th weeks and 12th weeks
Secondary outcomes (8)
walking fatigue
Walking Fatigue Index
Measured: Change from Baseline at 8th weeks and 12th weeks
perceived fatigue
Fatigue Severity Scale
Measured: Change from Baseline at 8th weeks and 12th weeks
physical fatigue
Modified Borg Scale before and after 6-minute walking test
Measured: Change from Baseline at 8th weeks and 12th weeks
static balance
Single standing tests
Measured: Change from Baseline at 8th weeks and 12th weeks
dynamic balance
4 square step tests
Measured: Change from Baseline at 8th weeks and 12th weeks
Functional activities 1
timed-up go test
Measured: Change from Baseline at 8th weeks and 12th weeks
Functional activities 2
2-minute walk test
Measured: Change from Baseline at 8th weeks and 12th weeks
Functional activities 3
25-feet walk test
Measured: Change from Baseline at 8th weeks and 12th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start15 Sep 2018
- Primary completion15 Apr 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanko University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zekiye ipek katırcı kırmacı, Sanko University
- Investigators
- TÜZÜN FIRAT, Study director, Hacettepe UniversityAYHAN ÖZKUR, Study chair, Sanko UniversityAYŞE MÜNİFE NEYAL, Study chair, Sanko UniversityABDURRAHMAN NEYAL, Study chair, Dr. Ersin Arslan Training and Research Hospital,NEVİN ERGUN, Study director, Sanko University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853654
- Sponsor's protocol ID
- ipekkirmaci
- Status last verified
- Dec 2021
- First submitted
- 11 Apr 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Selective Exercise Training on Muscle Architecture, Balance, Function and Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04853654
- Acronym / sponsor ID
- ipekkirmaci
- Conditions
- Multiple Sclerosis, Exercise
- Keywords
- multiple sclerosis, muscle architecture, Eccentric Exercise, Concentric Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sanko UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 21 Apr 2021 (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.
Selective exercise programs specific to muscle groups, with the workload to be done in line with the muscle's own structure, can enable more strength to be released with less fatigue in MS, and this increase in strength can increase balance and functional activities. to determine the effects of type training (selective exercise training), eccentric and concentric training on function, balance, fatigue and muscle architecture.
Detailed description
Recovery and enhancement of muscle function in MS is one of the main goals in physiotherapy and rehabilitation. In literature studies, it is stated that eccentric and concentric exercises are effective exercise approaches in increasing strength and reducing fatigue. However, the best exercise method is not yet clear in terms of providing better performance adaptation with less fatigue. Considering the architectural features of the lower extremity muscles, it is aimed to increase the angle of pennation with programs that include concentric strengthening of the quadriceps, gastro-soleus and gastrocnemius muscles, which are suitable muscle groups to produce large forces by design. With programs that include eccentric strengthening of the hamstring and tibialis anterior muscles that function in a wide range of motion and have high excursion ability, it is aimed to increase fiber length.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Selective training | Experimental | Other: exerciseselective training on lower extremity for 3 days/week |
| Downhill walking | Experimental | Other: exercisedownhill walking training on the treadmill for 2 days/week |
| Uphill walking | Experimental | Other: exerciseuphill walking training on the treadmill for 2 days/week |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between the ages of 18-50,
- With an Extended Disability Status Scale (EDSS) score of 4 or less,
- No regular exercise habit
- Able to walk on the treadmill,
- No pregnancy,
Key exclusion criteria (1 listed)
- patients who do not agree to volunteer
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 |
|---|---|---|
| exerciseexercise training for 8 weeks | Other | Downhill walking, Selective training, Uphill walking |
Primary outcome
muscle architecture parameter 1
Time frame: Change from Baseline at 8th weeks and 12th weeks
The pennation angle were evaluated with Ultrasound
muscle architecture parameter 2
Time frame: Change from Baseline at 8th weeks and 12th weeks
The fiber length were evaluated with Ultrasound
muscle architecture parameter 3
Time frame: Change from Baseline at 8th weeks and 12th weeks
The muscle thickness were evaluated with Ultrasound
Muscle strength
Time frame: Change from Baseline at 8th weeks and 12th weeks
low extremity muscles were evaluated with hand dynamometer
8 secondary outcomes
walking fatigue
Time frame: Change from Baseline at 8th weeks and 12th weeks
perceived fatigue
Time frame: Change from Baseline at 8th weeks and 12th weeks
physical fatigue
Time frame: Change from Baseline at 8th weeks and 12th weeks
static balance
Time frame: Change from Baseline at 8th weeks and 12th weeks
dynamic balance
Time frame: Change from Baseline at 8th weeks and 12th weeks
Functional activities 1
Time frame: Change from Baseline at 8th weeks and 12th weeks
Functional activities 2
Time frame: Change from Baseline at 8th weeks and 12th weeks
Functional activities 3
Time frame: Change from Baseline at 8th weeks and 12th weeks
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 13 Jan 2022.
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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.
TÜZÜN FIRAT study director
Hacettepe University
AYHAN ÖZKUR study chair
Sanko University
AYŞE MÜNİFE NEYAL study chair
Sanko University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Multiple Sclerosis and Exercise, run by Sanko University at 1 site in Turkey (Türkiye).
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 8 inclusion and 1 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 13 Jan 2022. 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 Turkey (Türkiye). 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 architecture parameter 1 (time frame: Change from Baseline at 8th weeks and 12th weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2022.