Clinical trial NCT03318120: Exercise Training in Dystonia
Official title: Exercise Training in Dystonia and Other Involuntary Movement Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 11
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate how the brain and motor behavior changes in individuals with dystonia and other involuntary movement disorders and healthy individuals over time with exercise training.

Detailed description: The study team plan to conduct a randomized prospective, parallel-group, controlled study to examine the effects of exercises in dystonia and other involuntary movement disorders. Patients will be randomized to receive either progressive resistance training or a control treatment following the modified fitness protocol. The study team hypothesize that progressive resistance training will result in better outcomes compared to modified fitness protocol.

Data collect includes 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities (the Montreal Cognitive Assessment, Stroop, Digit Span, Hopkins Verbal Learning Test, COWA and Animals, and Brief Test of Attention); 4) tests assessing motor abilities including Toronto Western Spasmodic Rating Scale (TWSTRS) and Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS); 5) measures of anxiety and depression (Beck Depression Index, Hamilton Anxiety and Depression Rating Scales); 5) Cervical dystonia related quality of life (CDQ-24); 6) Visual Analog Scales-Quality of Life (VAS QOL) evaluating of health related quality of life.

Eligibility criteria: Inclusion Criteria:

Patients with dystonia and other involuntary movement disorders will be recruited whose diagnosis will be confirmed by a Movement Disorders specialist following the criteria recommended by movement disorders society.

* Patients will be eligible if they are ages 30 to 80 years,
* Receive stable doses of regular botulinum toxin injections and are on stable doses of oral pharmacological therapy if applicable, and are able to walk for 6 minutes.
* Age-matched healthy individuals will be recruited for normative data.
* All individuals must be capable of providing informed consent and complying with the study related procedures.

Exclusion Criteria:

Patients will be ineligible if they have a neurological history other than dystonia, have significant arthritis

* Fail the Physical Activity Readiness Questionnaire, have cognitive impairment as indicated by a Mini Mental State Examination score \<23,
* Already exercising.
* As necessitated by the risks of Magnetic Resonance Imaging (MRI) or transcranial magnetic stimulation (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.
* Individuals who are claustrophobic will also be excluded from participation.
* Women who are or might be pregnant and nursing mothers are not eligible. 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.

Primary outcomes:
measure: Toronto Western Spasmodic Torticollis Rating Scale Score
timeFrame: Baseline through 24 months
measure: Burke-Fahn-Marsden Dystonia Rating Scale score
timeFrame: Baseline through 24 months
Secondary outcomes:
measure: Transcranial Magnetic Stimulation (TMS)
timeFrame: Baseline through 24 months
measure: Oral Medication
timeFrame: Baseline through 24 months
measure: Changes in blood oxygen level-dependent (BOLD) signal
timeFrame: Baseline through 24 months
measure: Hand grip dynamometer
timeFrame: Baseline through 24 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Aparna Wagle Shukla, M.D.
role: PRINCIPAL_INVESTIGATOR
References: