The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients

NCT01816100 | Completed DMC

• 1 other identifier: 0039-13-EP
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a unique blend of new technologies never used in combination with individuals diagnosed with Multiple Sclerosis (MS). The results of this research will define changes in brain activity, functional brain activation and diffusion in the brain following 6 months of structured weight resistance and balance training. Positive changes would indicate that the therapy has ignited brain plasticity and may drive the brain to repair itself. These changes to the brain may affect recovery as a result of neuroplasticity, neuroprotection, and slowing of neural degeneration. No other trials have been published evaluating brain plasticity utilizing diffusion tensor imaging (DTI) and magnetoencephalography (MEG) in subjects with MS undergoing physical training. DTI has demonstrated the ability to find changes (plasticity) that occur in the brain and using the MEG findings to focus the DTI analysis will optimize the capacity to detect changes secondary to therapy. This quantification will give a better understanding of the repair that goes on in the brain, and may potentially revolutionize the field of the central nervous system (CNS) rehabilitation. One of the most innovative aspects of this study is the full integration of clinical neurobehavioral metrics and functional imaging data in conjunction with a proven MS therapy along with quality of life indicators. This approach will allow new links to be illuminated as the trajectories of functional and structural brain changes (neuroplasticity) are meshed with clinical improvement indices collected visit-by-visit. This study will also compare disease modifying treatments (DMTs) and their effect(s) on indices of brain plasticity and cognitive and behavioral assessments.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; exercise; MEG; DTI; Brain changes

Outcome Measures

Primary Outcomes (1)

• Determine activation differences in neural regions serving motor function

  Determine activation differences in the neural regions serving motor function using MEG in a group of MS patients, comparing MS affected portions of the brain versus non-affected .Comparison of MEG and DTI measures and whether changes occur after an exercise intervention.

  measure after 6 months training session

Secondary Outcomes (1)

• Effect of a 6 month resistance and balance program on activation in sensorimotor brain areas

  following 6 months of exercise sessions

Other Outcomes (1)

• Effect of a 6 month resistance and balance program on brain diffusivity and fractional anisotropy

  Following 6 month exercise session

Study Arms (1)

exercise session

EXPERIMENTAL

6 months weight resistance session, with before/after evaluations by MEG and DTI. Fifty minute exercise sessions, twice weekly will be done. Each session will rotate between 3 separate exercise protocols: Static weights, free weights and balance. Exercises will be done with each extremity independently. For consistency and convenience, the resistance training will be performed at Fast Forward Gym, Omaha, NE. The primary outcome exercise data include strength and endurance

Other: specifically design 6 month resistance training program; Behavioral: 6 months weight resistance and balance program

Interventions

specifically design 6 month resistance training program OTHER

Data will be kept on the number of repetitions and amount of weight per exercise session See intervention description

Also known as: 6 months weight resistance session,

exercise session

6 months weight resistance and balance program BEHAVIORAL

3 phases first phase-strength improvement using stationary machines second phase-time is divided between stationary machines, balance, dexterity third phase-free weight movements

Also known as: 50-minute, biweekly sessions for 6 months

exercise session

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of relapsing/remitting or secondary progressive MS by McDonald Criteria (for patient groups)
• Competent to give informed consent.
• ≥ 19 years and \<65 years of age.
• EDSS score \<7.0 and able to walk 25 feet with or without a cane.
• Willingness to comply with the evaluation schedule for the study. This includes participation in a bi-weekly standardized structured resistance training and separate data collections done at each time point (baseline and 3 months).
• Evidence that the MS patient's physical and neurological examinations are "clinically acceptable." Clinically acceptable is defined as those clinical findings or conditions that would not place the patient in undue risk by participating and which would not interfere with outcome measures of the study.

You may not qualify if:

• Unable to give informed consent.
• Unable or unwilling to sign safety waiver.
• EDSS score ≥7 or are unable to walk 25 feet with the use of a cane
• Unwilling or unable to complete the exercise program and other aspects of the study (e.g., not keeping appointments, lack of active participation in the exercise sessions, or displaying inability to follow instructions allowing appropriate exercise advancement).
• Pregnant, breastfeeding or within 3 months post partum at initiation of study.
• Have any other disability that would affect balance and/or mobility.
• Have any other neurological or neurodegenerative disorders.
• Have any other conditions, clinical findings or reason that deems the subject unsuitable for enrollment into the study.
• Have an implantable device or history of metal in body.

Sponsors & Collaborators

• University of Nebraska: lead
• Biogen: collaborator

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Mary L Filipi, PhD, APRN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: March 21, 2013
• Study Start: September 16, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

US (1)