Exercise Training in Dystonia

Not Applicable

Completed

• Conditions: Dystonia
• Interventions: Behavioral: Progressive Resistance Training

• Registration Number: NCT03318120
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-23
• Study Start: 2017-11-06
• Primary Completion: 2022-06-24
• Study Completion: 2022-06-24
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive Resistance Training	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.

Primary Outcome Measures

Name	Time	Method
Burke-Fahn-Marsden Dystonia Rating Scale score	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.
Toronto Western Spasmodic Torticollis Rating Scale Score	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).

Secondary Outcome Measures

Name	Time	Method
Oral Medication	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	Baseline through 24 months	Investigate changes in motor cortex excitability via blood oxygen level-dependent (BOLD) signal before and after exercise intervention
Transcranial Magnetic Stimulation (TMS)	Baseline through 24 months	Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention
Hand grip dynamometer	Baseline through 24 months	Investigate changes in maximum hand grip strength

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States