Exercise Training in Dystonia

NCT03318120 | Completed

• 3 other identifiers: IRB20170222440115065OCR28822
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Transcranial Magnetic Stimulation (TMS)

  Baseline through 24 months

• Oral Medication

  Baseline through 24 months

• Changes in blood oxygen level-dependent (BOLD) signal

  Baseline through 24 months

• Hand grip dynamometer

  Baseline through 24 months

Study Arms (2)

Progressive Resistance Training

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

Progressive Resistance Training BEHAVIORAL

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).

Progressive Resistance Training

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Conditions

Dystonia

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aparna Wagle Shukla, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 23, 2017
• Study Start: November 6, 2017
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)