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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanko University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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: Nevin 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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