Exercise Training in Dystonia
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|ClinicalTrials.gov Identifier: NCT03318120|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : September 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dystonia||Behavioral: Progressive Resistance Training||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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.
- 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
- Oral Medication [ Time Frame: Baseline through 24 months ]Investigate changes in oral medications taken by participants before and after exercise intervention
- 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
- Hand grip dynamometer [ Time Frame: Baseline through 24 months ]Investigate changes in maximum hand grip strength
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
|Contact: Zakia Jabarkheel, B.S.||firstname.lastname@example.org|
|Contact: Johanna L McCracken, B.S.||email@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32611|
|Contact: Zakia Jabarkheel, B.S. 904-710-4195 firstname.lastname@example.org|
|Contact: Johanna McCracken, B.S. 9048140765 email@example.com|
|Principal Investigator: Aparna Wagle Shukla, M.D.|
|Sub-Investigator: David Valliancourt, Ph.D.|
|Principal Investigator:||Aparna Wagle Shukla, M.D.||University of Florida|