- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04853654
Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis
December 27, 2021 updated by: zekiye ipek katırcı kırmacı, Sanko University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Gaziantep, Turkey
- Zekiye İpek Katırcı Kırmacı
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
patients who do not agree to volunteer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Selective training
selective training on lower extremity for 3 days/week
|
exercise training for 8 weeks
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Experimental: Downhill walking
downhill walking training on the treadmill for 2 days/week
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exercise training for 8 weeks
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Experimental: Uphill walking
uphill walking training on the treadmill for 2 days/week
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exercise training for 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
muscle architecture parameter 1
Time Frame: Change from Baseline at 8th weeks and 12th weeks
|
The pennation angle were evaluated with Ultrasound
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Change from Baseline at 8th weeks and 12th weeks
|
muscle architecture parameter 2
Time Frame: Change from Baseline at 8th weeks and 12th weeks
|
The fiber length were evaluated with Ultrasound
|
Change from Baseline at 8th weeks and 12th weeks
|
muscle architecture parameter 3
Time Frame: Change from Baseline at 8th weeks and 12th weeks
|
The muscle thickness were evaluated with Ultrasound
|
Change from Baseline at 8th weeks and 12th weeks
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Muscle strength
Time Frame: Change from Baseline at 8th weeks and 12th weeks
|
low extremity muscles were evaluated with hand dynamometer
|
Change from Baseline at 8th weeks and 12th weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
walking fatigue
Time Frame: Change from Baseline at 8th weeks and 12th weeks
|
Walking Fatigue Index
|
Change from Baseline at 8th weeks and 12th weeks
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perceived fatigue
Time Frame: Change from Baseline at 8th weeks and 12th weeks
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Fatigue Severity Scale
|
Change from Baseline at 8th weeks and 12th weeks
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physical fatigue
Time Frame: Change from Baseline at 8th weeks and 12th weeks
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Modified Borg Scale before and after 6-minute walking test
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Change from Baseline at 8th weeks and 12th weeks
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static balance
Time Frame: Change from Baseline at 8th weeks and 12th weeks
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Single standing tests
|
Change from Baseline at 8th weeks and 12th weeks
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dynamic balance
Time Frame: Change from Baseline at 8th weeks and 12th weeks
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4 square step tests
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Change from Baseline at 8th weeks and 12th weeks
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Functional activities 1
Time Frame: Change from Baseline at 8th weeks and 12th weeks
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timed-up go test
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Change from Baseline at 8th weeks and 12th weeks
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Functional activities 2
Time Frame: Change from Baseline at 8th weeks and 12th weeks
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2-minute walk test
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Change from Baseline at 8th weeks and 12th weeks
|
Functional activities 3
Time Frame: Change from Baseline at 8th weeks and 12th weeks
|
25-feet walk test
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Change from Baseline at 8th weeks and 12th weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: TÜZÜN FIRAT, Hacettepe University
- Study Chair: AYHAN ÖZKUR, SANKO University
- Study Chair: AYŞE MÜNİFE NEYAL, SANKO University
- Study Chair: ABDURRAHMAN NEYAL, Dr. Ersin Arslan Training and Research Hospital,
- Study Director: NEVİN ERGUN, SANKO University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2018
Primary Completion (Actual)
April 15, 2020
Study Completion (Actual)
June 15, 2020
Study Registration Dates
First Submitted
April 11, 2021
First Submitted That Met QC Criteria
April 18, 2021
First Posted (Actual)
April 21, 2021
Study Record Updates
Last Update Posted (Actual)
January 13, 2022
Last Update Submitted That Met QC Criteria
December 27, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ipekkirmaci
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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