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

Status

Completed

Intervention / Treatment

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

      • Gaziantep, Turkey
        • Zekiye İpek Katırcı Kırmacı

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

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
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
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
perceived fatigue
Time Frame: Change from Baseline at 8th weeks and 12th weeks
Fatigue Severity Scale
Change from Baseline at 8th weeks and 12th weeks
physical fatigue
Time Frame: Change from Baseline at 8th weeks and 12th weeks
Modified Borg Scale before and after 6-minute walking test
Change from Baseline at 8th weeks and 12th weeks
static balance
Time Frame: Change from Baseline at 8th weeks and 12th weeks
Single standing tests
Change from Baseline at 8th weeks and 12th weeks
dynamic balance
Time Frame: Change from Baseline at 8th weeks and 12th weeks
4 square step tests
Change from Baseline at 8th weeks and 12th weeks
Functional activities 1
Time Frame: Change from Baseline at 8th weeks and 12th weeks
timed-up go test
Change from Baseline at 8th weeks and 12th weeks
Functional activities 2
Time Frame: Change from Baseline at 8th weeks and 12th weeks
2-minute walk test
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
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.

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

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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