NCT03429062

Brief Summary

This study will compare the benefits of two community based exercise programs, personal training and whole body vibration on balance and gait in people with Multiple Sclerosis. Anyone with a diagnosis of MS can participate in the personal training. Only people who can walk with or without an assistive device with a diagnosis of MS can participate in the Whole Body Vibration. Pre testing and post testing will be completed using balance and gait measures and self reporting measures for balance confidence and impact of MS. The program will run two times per week for six weeks.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

February 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

February 5, 2018

Last Update Submit

September 12, 2019

Conditions

Multiple Sclerosis

Keywords

balancegaitMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Mini Balance Evaluations Systems Test (MiniBEST Test)

    Measure of dynamic balance, scores range from 0 (no Balance) to 28 good dynamic balance.

    20 minutes

Secondary Outcomes (6)

  • Activities Specific Balance Scale

    15 minutes

  • Fatigue Severity Scale

    10 minutes

  • Multiple Sclerosis Impact Scale

    15 minutes

  • Dynamic Gait Index

    15 minutes

  • 5 Times Sit to Stand Test

    1 minute

  • +1 more secondary outcomes

Study Arms (2)

personal training

Individuals with a diagnosis of MS and any level of function will be recruited to participate in exercise two times per week with trained personal trainers. Exercise consists of strengthening, stretching, balance, endurance and gait when able. Equipment to be used include treadmill, stationary bike, weight equipment.

Other: Personal training exercises

Whole Body Platform

Individuals with a diagnosis of MS and able to walk with or without an assistive device will be recruited to participate in whole body platform training two times per week with a physical therapist. The exercise on the whole body platform includes strengthening, balance, stretching, and endurance for 30 second bouts. The whole body platform is on for 30 seconds then off. Each exercise will use the 30 seconds to complete.

Other: Personal training exercises

Interventions

Personal training exercisesOTHER

Personal training: strengthening, stretching, endurance, balance Whole body vibration: strengthening, balance, stretching, endurance, balance

Also known as: whole body vibration platform exercise
Whole Body Platformpersonal training

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes adults (18-85 years) with a diagnosis of Multiple Sclerosis. This is a sample of convenience, with recruitment occurring at MindSet Fitness and Yoga where exercise classes for people with MS occur every Tuesday and Thursday.

You may qualify if:

  • Definite diagnosis of MS,
  • able to read, understand and sign the consent to participate form,
  • adults between 18 and 85 years,
  • attend a pre and post test session of 60-120 minutes

You may not qualify if:

  • unable to read, understand the consent to participate form,
  • unable to participate in any exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MINDSET Fitness and Yoga

Fort Worth, Texas, 76117, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Linda A Csiza, PT, DSc

    Texas Woman's University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

February 13, 2018

Primary Completion

February 13, 2019

Study Completion

February 13, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)