search
Back to results

Exercise Training in Dystonia

Primary Purpose

Dystonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive Resistance Training
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Progressive Resistance Training

Control Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Transcranial Magnetic Stimulation (TMS)
Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention
Oral Medication
Investigate changes in oral medications taken by participants before and after exercise intervention
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
Hand grip dynamometer
Investigate changes in maximum hand grip strength

Full Information

First Posted
September 28, 2017
Last Updated
September 19, 2022
Sponsor
University of Florida
search

1. Study Identification

Unique Protocol Identification Number
NCT03318120
Brief Title
Exercise Training in Dystonia
Official Title
Exercise Training in Dystonia and Other Involuntary Movement Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
June 24, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Progressive Resistance Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Resistance Training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Toronto Western Spasmodic Torticollis Rating Scale Score
Description
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).
Time Frame
Baseline through 24 months
Title
Burke-Fahn-Marsden Dystonia Rating Scale score
Description
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.
Time Frame
Baseline through 24 months
Secondary Outcome Measure Information:
Title
Transcranial Magnetic Stimulation (TMS)
Description
Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention
Time Frame
Baseline through 24 months
Title
Oral Medication
Description
Investigate changes in oral medications taken by participants before and after exercise intervention
Time Frame
Baseline through 24 months
Title
Changes in blood oxygen level-dependent (BOLD) signal
Description
Investigate changes in motor cortex excitability via blood oxygen level-dependent (BOLD) signal before and after exercise intervention
Time Frame
Baseline through 24 months
Title
Hand grip dynamometer
Description
Investigate changes in maximum hand grip strength
Time Frame
Baseline through 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aparna Wagle Shukla, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available without any personal identifiers included.

Learn more about this trial

Exercise Training in Dystonia

We'll reach out to this number within 24 hrs