NCT04853654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

April 11, 2021

Last Update Submit

December 27, 2021

Conditions

Multiple SclerosisExercise

Keywords

multiple sclerosismuscle architectureEccentric ExerciseConcentric Exercise

Outcome Measures

Primary Outcomes (4)

  • muscle architecture parameter 1

    The pennation angle were evaluated with Ultrasound

    Change from Baseline at 8th weeks and 12th weeks

  • muscle architecture parameter 2

    The fiber length were evaluated with Ultrasound

    Change from Baseline at 8th weeks and 12th weeks

  • muscle architecture parameter 3

    The muscle thickness were evaluated with Ultrasound

    Change from Baseline at 8th weeks and 12th weeks

  • Muscle strength

    low extremity muscles were evaluated with hand dynamometer

    Change from Baseline at 8th weeks and 12th weeks

Secondary Outcomes (8)

  • walking fatigue

    Change from Baseline at 8th weeks and 12th weeks

  • perceived fatigue

    Change from Baseline at 8th weeks and 12th weeks

  • physical fatigue

    Change from Baseline at 8th weeks and 12th weeks

  • static balance

    Change from Baseline at 8th weeks and 12th weeks

  • dynamic balance

    Change from Baseline at 8th weeks and 12th weeks

  • +3 more secondary outcomes

Study Arms (3)

Selective training

EXPERIMENTAL

selective training on lower extremity for 3 days/week

Other: exercise

Downhill walking

EXPERIMENTAL

downhill walking training on the treadmill for 2 days/week

Other: exercise

Uphill walking

EXPERIMENTAL

uphill walking training on the treadmill for 2 days/week

Other: exercise

Interventions

exerciseOTHER

exercise training for 8 weeks

Downhill walkingSelective trainingUphill walking

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • patients who do not agree to volunteer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zekiye İpek Katırcı Kırmacı

Gaziantep, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • TÜZÜN FIRAT

    Hacettepe University

    STUDY DIRECTOR

  • AYHAN ÖZKUR

    Sanko University

    STUDY CHAIR

  • AYŞE MÜNİFE NEYAL

    Sanko University

    STUDY CHAIR

  • ABDURRAHMAN NEYAL

    Dr. Ersin Arslan Training and Research Hospital,

    STUDY CHAIR

  • NEVİN ERGUN

    Sanko University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 21, 2021

Study Start

September 15, 2018

Primary Completion

April 15, 2020

Study Completion

June 15, 2020

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

TU(1)