Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Exercise
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercise
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, muscle architecture, Eccentric Exercise, Concentric Exercise
Eligibility Criteria
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
Sites / Locations
- Zekiye İpek Katırcı Kırmacı
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Selective training
Downhill walking
Uphill walking
Arm Description
selective training on lower extremity for 3 days/week
downhill walking training on the treadmill for 2 days/week
uphill walking training on the treadmill for 2 days/week
Outcomes
Primary Outcome Measures
muscle architecture parameter 1
The pennation angle were evaluated with Ultrasound
muscle architecture parameter 2
The fiber length were evaluated with Ultrasound
muscle architecture parameter 3
The muscle thickness were evaluated with Ultrasound
Muscle strength
low extremity muscles were evaluated with hand dynamometer
Secondary Outcome Measures
walking fatigue
Walking Fatigue Index
perceived fatigue
Fatigue Severity Scale
physical fatigue
Modified Borg Scale before and after 6-minute walking test
static balance
Single standing tests
dynamic balance
4 square step tests
Functional activities 1
timed-up go test
Functional activities 2
2-minute walk test
Functional activities 3
25-feet walk test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04853654
Brief Title
Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis
Official Title
Investigation of the Effects of Selective Exercise Training on Muscle Architecture, Balance, Function and Fatigue in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
June 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanko University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Exercise
Keywords
multiple sclerosis, muscle architecture, Eccentric Exercise, Concentric Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Selective training
Arm Type
Experimental
Arm Description
selective training on lower extremity for 3 days/week
Arm Title
Downhill walking
Arm Type
Experimental
Arm Description
downhill walking training on the treadmill for 2 days/week
Arm Title
Uphill walking
Arm Type
Experimental
Arm Description
uphill walking training on the treadmill for 2 days/week
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
exercise training for 8 weeks
Primary Outcome Measure Information:
Title
muscle architecture parameter 1
Description
The pennation angle were evaluated with Ultrasound
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
muscle architecture parameter 2
Description
The fiber length were evaluated with Ultrasound
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
muscle architecture parameter 3
Description
The muscle thickness were evaluated with Ultrasound
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
Muscle strength
Description
low extremity muscles were evaluated with hand dynamometer
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Secondary Outcome Measure Information:
Title
walking fatigue
Description
Walking Fatigue Index
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
perceived fatigue
Description
Fatigue Severity Scale
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
physical fatigue
Description
Modified Borg Scale before and after 6-minute walking test
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
static balance
Description
Single standing tests
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
dynamic balance
Description
4 square step tests
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
Functional activities 1
Description
timed-up go test
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
Functional activities 2
Description
2-minute walk test
Time Frame
Change from Baseline at 8th weeks and 12th weeks
Title
Functional activities 3
Description
25-feet walk test
Time Frame
Change from Baseline at 8th weeks and 12th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TÜZÜN FIRAT
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
AYHAN ÖZKUR
Organizational Affiliation
Sanko University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
AYŞE MÜNİFE NEYAL
Organizational Affiliation
Sanko University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ABDURRAHMAN NEYAL
Organizational Affiliation
Dr. Ersin Arslan Training and Research Hospital,
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
NEVİN ERGUN
Organizational Affiliation
Sanko University
Official's Role
Study Director
Facility Information:
Facility Name
Zekiye İpek Katırcı Kırmacı
City
Gaziantep
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis
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