DystoniaNCT03318120
Exercise Training in Dystonia
A study testing Progressive Resistance Training in people with Dystonia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Dystonia
- What is being tested?
- Progressive Resistance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2017to 24 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Training in Dystonia and Other Involuntary Movement Disorders
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.
Read the 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.
- Conditions
- Dystonia
- Being tested
- Progressive Resistance Training
- Medical subject headings
- Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance TrainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Baseline through 24 months
Secondary outcomes (4)
Transcranial Magnetic Stimulation (TMS)
Investigate changes in motor cortex excitability via transcranial magnetic stimulation before and after exercise intervention
Measured: Baseline through 24 months
Oral Medication
Investigate changes in oral medications taken by participants before and after exercise intervention
Measured: Baseline through 24 months
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
Measured: Baseline through 24 months
Hand grip dynamometer
Investigate changes in maximum hand grip strength
Measured: Baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start6 Nov 2017
- Primary completion24 Jun 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aparna Wagle Shukla, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318120
- Sponsor's protocol ID
- IRB201702224
- Other IDs
- 40115065, OCR28822
- Status last verified
- Sep 2022
- First submitted
- 28 Sep 2017
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available without any personal identifiers included.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training in Dystonia and Other Involuntary Movement Disorders
- ClinicalTrials.gov ID
- NCT03318120
- Acronym / sponsor ID
- IRB201702224
- Conditions
- Dystonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Resistance Training | Experimental | Behavioral: Progressive Resistance TrainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance TrainingParticipants 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). | Behavioural | Progressive Resistance Training |
Primary outcome
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.
4 secondary outcomes
Transcranial Magnetic Stimulation (TMS)
Time frame: Baseline through 24 months
Oral Medication
Time frame: Baseline through 24 months
Changes in blood oxygen level-dependent (BOLD) signal
Time frame: Baseline through 24 months
Hand grip dynamometer
Time frame: Baseline through 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes. Individual participant data will be available without any personal identifiers included.
Related trials for Dystonia
Active, not recruitingPhase 1/2
Deep Brain Stimulation Surgery for Focal Hand Dystonia
Dystonia, Focal Dystonia
RecruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
Active, not recruiting
Accelerated TMS for Focal Hand Dystonia
Isolated Focal Hand Dystonia
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of VIM0423 in Individuals With Isolated Dystonia
Dystonia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aparna Wagle Shukla, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Training in people with Dystonia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toronto Western Spasmodic Torticollis Rating Scale Score (time frame: Baseline through 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.