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Exercise Training in Dystonia

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ClinicalTrials.gov Identifier: NCT03318120
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment Phase
Dystonia Behavioral: Progressive Resistance Training Behavioral: Standardized Exercise Training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Training in Dystonia and Other Involuntary Movement Disorders
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020


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 and thereafter once a week for up to three years.
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).

Active Comparator: Standardized Exercise Training
Participants assigned to this arm will receive a set of standardized exercises comprising of stretching, balancing and strengthening under the supervision of a personal trainer at a gym facility that is close to their home. They will be required to perform these exercises twice a week for the first six months and thereafter once a week for up to three years.
Behavioral: Standardized Exercise Training
Participants will perform required stretching, balancing, and strengthening 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).




Primary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating Scale Score [ Time Frame: Baseline through 24 months ]
    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).

  2. Burke-Fahn-Marsden Dystonia Rating Scale score [ Time Frame: Baseline through 24 months ]
    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.


Secondary Outcome Measures :
  1. Transcranial Magnetic Stimulation (TMS) [ Time Frame: Baseline through 24 months ]
    Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention

  2. Oral Medication [ Time Frame: Baseline through 24 months ]
    Investigate changes in oral medications taken by participants before and after exercise intervention

  3. Changes in blood oxygen level-dependent (BOLD) signal [ Time Frame: Baseline through 24 months ]
    Investigate changes in motor cortex excitability via blood oxygen level-dependent (BOLD) signal before and after exercise intervention

  4. Hand grip dynamometer [ Time Frame: Baseline through 24 months ]
    Investigate changes in maximum hand grip strength



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318120


Contacts
Contact: Zakia Jabarkheel, B.S. 9047104195 zakia.jabarkheel@neurology.ufl.edu
Contact: Johanna L McCracken, B.S. 9048140765 jmccracken@ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Zakia Jabarkheel, B.S.    904-710-4195    zakia.jabarkheel@neurology.ufl.edu   
Contact: Johanna McCracken, B.S.    9048140765    jmccracken@ufl.edu   
Principal Investigator: Aparna Wagle Shukla, M.D.         
Sub-Investigator: David Valliancourt, Ph.D.         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Aparna Wagle Shukla, M.D. University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03318120     History of Changes
Other Study ID Numbers: IRB201702224
Pending ( Other Identifier: Florida State )
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available without any personal identifiers included.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases