Effects of Exercise on Dystonia Pathophysiology
ConditionDystonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Florida
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Progressive resistance exercise
BehavioralPatients 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.
Standard of care
BehavioralSubjects will receive SOC therapy only
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Progressive resistance exercise (exercise group)Experimental treatment 1 intervention
Group B: Standard of care (non-exercise group).Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Brain effects measured with fMRI
To measure change in BOLD (fMRI) signals to functional connectivity in active group vs the control group.
Time frame
Baseline up to 6 months2
Brain effects measured with TMS
To measure motor cortex excitability and plasticity in TMS findings.
Time frame
Baseline up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov