NCT03497468

Brief Summary

Multiple Sclerosis (MS) is inflammatory, demyelinating and autoimmune disease of the central nervous system. It is usually seen with relapses and genetic and environmental factors play a role in the etiology. Neurological symptoms seen in MS restrict the patient's daily activity and social role participation. Mobility problems and fatigue are the most important reasons of role limitations and decreased quality of life. The importance of exercise training in disease management has been emphasized in recent years. However, few studies have investigated the effects of task-oriented trainings on symptoms of the disease. The aim of this sudy is to investigate the effects of task-oriented training additional to combined exercise training on functional capacity, mobility, balance, fatigue and quality of life in patients with MS.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

April 3, 2018

Last Update Submit

April 12, 2018

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

task-oriented trainingexercise trainingmobilitybalancefatiguequality of life

Outcome Measures

Primary Outcomes (1)

  • Functional capacity

    Change from baseline functional capacity with six minute walking test

    6 weeks

Secondary Outcomes (8)

  • dynamic gait skills

    6 weeks

  • limitation of gait

    6 weeks

  • dynamic balance and fall risk

    6 weeks

  • sitatic balance

    6 weeks

  • dynamic balance

    6 weeks

  • +3 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients in this group will receive combined exercise training included aerobic and strengthening exercises, 3 times a week for 6 weeks. All exercise sessions will be performed under the supervision of a physiotherapist.

Other: Combined exercise training

Training group

EXPERIMENTAL

Patients in this group will receive task-oriented training additional to combined exercise training 3 times a week for 6 weeks. Task-oriented training included more functional daily life mobility activities like reaching, obstacle walking, stairs climbing. All exercise sessions will be performed under the supervision of a physiotherapist.

Other: Task-oriented training

Interventions

Combined exercise trainingOTHER

Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities

Control group
Task-oriented trainingOTHER

Functional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface

Training group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multiple Sclerosis diagnosis
  • Expanded Disability Status Scale \> 5,5
  • No cognitive problems
  • No relapses in the last 3 months
  • No other neurological or chronic disease

You may not qualify if:

  • Relapse during the intervention
  • Exercise intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingFatigue

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kamer Unal-Eren, PT, PhD

CONTACT

+902125232288kamerunals@yahoo.com

Study Design

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

Study Record Dates

First Submitted

April 3, 2018

First Posted

April 13, 2018

Study Start

April 1, 2018

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

April 13, 2018

Record last verified: 2018-04