Exercise Training in Dystonia

Exercise Training in Dystonia and Other Involuntary Movement Disorders

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.

Study Overview

• Status: Completed
• Conditions: Dystonia
• Intervention / Treatment: Behavioral: Progressive Resistance 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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Progressive Resistance Training; Participants assigned to this arm will receive progressive resistance training under the supervision of a personal trainer at a gym facility close to their home. They will be required to perform these exercises twice a week for the first six months. They will be monitored with an activity monitor.	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).
No Intervention: Control Arm; The control arm offered to subjects with dystonia and other involuntary muscle disorders, participants will be followed at baseline and 6 months similar to what will be done in active exercise arm but this arm will not receive exercise. They will be monitored with an activity monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcranial Magnetic Stimulation (TMS)	Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention	Baseline through 24 months
Oral Medication	Investigate changes in oral medications taken by participants before and after exercise intervention	Baseline through 24 months
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
Hand grip dynamometer	Investigate changes in maximum hand grip strength	Baseline through 24 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Aparna Wagle Shukla, M.D., University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Dystonia; Dystonic Disorders
• Other Study ID Numbers: IRB201702224; 40115065 (Other Identifier: State of Florida); OCR28822 (Other Identifier: UF Oncore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual participant data will be available without any personal identifiers included.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No