NCT01632293

Brief Summary

The purpose is to see how multiple sclerosis (MS) is associated with strength and sensation using MRI, in persons with MS. The investigators will also see whether exercise can improve these symptoms for persons with MS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable multiple-sclerosis

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

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

3.4 years

First QC Date

June 28, 2012

Last Update Submit

February 22, 2016

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Change in maximal voluntary contraction of the hip flexors from baseline to end of training and to post-training

    Here, we will assess whether the degree of a person's white matter integrity (i.e. for tracts of interest as measured from MRI) predicts their ability to benefit from exercise. Our prediction is that those individuals with preserved white matter integrity will show the greatest improvement in hip flexor strength.

    Participants are assessed at baseline (visit 1, enrollment), end of training (visit 2, week 12) and post-training (visit 3, week 24).

Study Arms (1)

exercise

EXPERIMENTAL

Individuals with multiple sclerosis and age and gender matched healthy controls will participate in a supervised exercise program for 12 weeks.

Behavioral: progressive resistance training

Interventions

progressive resistance trainingBEHAVIORAL

The exercise program uses guided progressive resistance training to provide an individualized program of strength training. The progressive resistance training intervention will consist of 12 weeks of guided resistance training twice weekly; in addition, subjects will be instructed to do one day of progressive resistance training at the home weekly.

Also known as: strength, exercise training
exercise

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of MS
  • If on immunomodulatory therapy, subjects have to have been on that therapy for at least 6 months prior to the start of the study.
  • Medically stable
  • Able to follow complex directions as determined by a score of less than or equal to 1 on a subset of questions taken from the NIH Stroke scale
  • Normal passive range of motion at the hips, knees, and ankles with minimum to no pain

You may not qualify if:

  • Evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
  • Congestive heart failure
  • MS exacerbation within 8 weeks of study start
  • MS exacerbation affecting CST or DC-ML tracts
  • peripheral artery disease with claudication
  • cancer
  • pulmonary or renal failure
  • unstable angina
  • uncontrolled hypertension (greater than 190/110 mmHg)
  • orthopedic or pain conditions
  • history of kidney disease, due to potential of gadolinium reactions leading to nephrogenic systemic fibrosis (NSF)
  • because pregnancy may change the MRI signals that we are studying, we have chosen not to enroll pregnant women in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Motion Analysis Lab

Baltimore, Maryland, 21205, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kathleen M Zackowski, Ph.D.

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 2, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

US(1)