RecruitingNot ApplicableNCT05663840

Effects of Exercise on Dystonia Pathophysiology

Progressive Resistance Exercise and Dystonia Pathophysiology.


Sponsor

University of Florida

Enrollment

56 participants

Start Date

Oct 13, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia in response to exercise training.


Eligibility

Min Age: 30 YearsMax Age: 85 Years

Inclusion Criteria5

  • Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society.
  • Moderate disease severity.
  • Are 30 to 85 years old
  • Are able to tolerate exercise sessions.
  • Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy.

Exclusion Criteria7

  • Participating in an alternate structured exercise program, receiving regular physical or occupational therapy
  • Have significant pain, spondylosis or active arthritis
  • Fail the Physical Activity Readiness Questionnaire
  • Have significant cognitive impairment
  • Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS
  • Active seizure disorder; not be eligible for TMS and claustrophobic for MRI portion. As necessitated by the risks of MRI or TMS, patients who have any type of implanted electrical device (such as a cardiac pacemaker or a neurostimulator), or a certain type of metallic clip in their body (i.e., an aneurysm clip in the brain), active seizure disorder are not eligible for participation in the MRI or TMS portion of the study.
  • Pregnancy tests will be carried out for each female subject of child bearing potential prior to the participation in the study and prior to each follow up visit (as indicated).

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Interventions

BEHAVIORALProgressive resistance exercise

Patients with predominant symptoms of cervical dystonia will receive exercise training. Patients will receive progressive resistance exercise focused cervical and shoulder training (PERFECT) plus standard-of-care (SOC) therapy. Resistance training will consist of mainly muscle-strengthening exercises for the neck, shoulder and arms and a few upper trunk muscles. Resistance training will be guided by physical therapists at twice a week schedule for 6 months. These participants will also receive SOC therapy.

BEHAVIORALStandard of care

Subjects will receive SOC therapy only


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT05663840


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