Exercise Training in Dystonia

Dystonia Clinical Trial

Official title:

Exercise Training in Dystonia and Other Involuntary Movement Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318120
• Other study ID #: IRB201702224
• Secondary ID: 40115065OCR28822
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: June 24, 2022

Study information

• Verified date: September 2022
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders

Intervention

Behavioral:
• Progressive Resistance Training
Participants will perform required resistance training exercises at regular intervals for a period of up to 3 years. They will be tested at a baseline visit, then every 6 months for a total of at least 5 visits. During these visits, they will be asked to complete the following: questionnaires about quality of life and depression, tests to measure strength and motor function, tests to measure cognition, an orientation session to learn a precision griping task, structural and functional MRI scans of the brain, measurement of brain waves using a non-invasive technique called electroencephalography (EEG) and muscle activity using electromyography (EMG), measurement of brain function with TMS, pregnancy test (if applicable).

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Western Spasmodic Torticollis Rating Scale Score	Investigate changes in clinical function before and after exercise intervention. A 35 point clinical tool for assessing and documenting the status of patients with spasmodic torticollis (cervical dystonia).	Baseline through 24 months
Primary	Burke-Fahn-Marsden Dystonia Rating Scale score	Investigate changes in clinical function before and after exercise intervention. This is a specific questionnaire for dystonia developed to assess the severity of the effect of dystonia on various parts of the body (eyes, mouth, speech/swallowing, neck, trunk, upper limb, and lower limb). Severity factors and provoking factors are rated on a scale from 0-4 and a total score is calculated.	Baseline through 24 months
Secondary	Transcranial Magnetic Stimulation (TMS)	Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention	Baseline through 24 months
Secondary	Oral Medication	Investigate changes in oral medications taken by participants before and after exercise intervention	Baseline through 24 months
Secondary	Changes in blood oxygen level-dependent (BOLD) signal	Investigate changes in motor cortex excitability via blood oxygen level-dependent (BOLD) signal before and after exercise intervention	Baseline through 24 months
Secondary	Hand grip dynamometer	Investigate changes in maximum hand grip strength	Baseline through 24 months