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Investigation of the Effects of Selective Exercise Training in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04853654
Recruitment Status : Completed
First Posted : April 21, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
zekiye ipek katırcı kırmacı, Sanko University

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Exercise Other: exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effects of Selective Exercise Training on Muscle Architecture, Balance, Function and Fatigue in Multiple Sclerosis
Actual Study Start Date : September 15, 2018
Actual Primary Completion Date : April 15, 2020
Actual Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Selective training
selective training on lower extremity for 3 days/week
Other: exercise
exercise training for 8 weeks

Experimental: Downhill walking
downhill walking training on the treadmill for 2 days/week
Other: exercise
exercise training for 8 weeks

Experimental: Uphill walking
uphill walking training on the treadmill for 2 days/week
Other: exercise
exercise training for 8 weeks




Primary Outcome Measures :
  1. muscle architecture parameter 1 [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    The pennation angle were evaluated with Ultrasound

  2. muscle architecture parameter 2 [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    The fiber length were evaluated with Ultrasound

  3. muscle architecture parameter 3 [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    The muscle thickness were evaluated with Ultrasound

  4. Muscle strength [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    low extremity muscles were evaluated with hand dynamometer


Secondary Outcome Measures :
  1. walking fatigue [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    Walking Fatigue Index

  2. perceived fatigue [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    Fatigue Severity Scale

  3. physical fatigue [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    Modified Borg Scale before and after 6-minute walking test

  4. static balance [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    Single standing tests

  5. dynamic balance [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    4 square step tests

  6. Functional activities 1 [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    timed-up go test

  7. Functional activities 2 [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    2-minute walk test

  8. Functional activities 3 [ Time Frame: Change from Baseline at 8th weeks and 12th weeks ]
    25-feet walk test



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853654


Locations
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Turkey
Zekiye İpek Katırcı Kırmacı
Gaziantep, Turkey
Sponsors and Collaborators
Sanko University
Investigators
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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
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Responsible Party: zekiye ipek katırcı kırmacı, assistant professor, Sanko University
ClinicalTrials.gov Identifier: NCT04853654    
Other Study ID Numbers: ipekkirmaci
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by zekiye ipek katırcı kırmacı, Sanko University:
multiple sclerosis
muscle architecture
Eccentric Exercise
Concentric Exercise
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases