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Effects of Exercise on Dystonia Pathophysiology

Primary Purpose

Dystonia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Progressive resistance exercise
Standard of care
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 - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society. Moderate disease severity. Are 30 to 85 years old Are able to tolerate exercise sessions. Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy. Exclusion Criteria: Participating in an alternate structured exercise program, receiving regular physical or occupational therapy Have significant pain, spondylosis or active arthritis Fail the Physical Activity Readiness Questionnaire Have significant cognitive impairment Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS Active seizure disorder; not be eligible for TMS and claustrophobic for MRI portion. As necessitated by the risks of MRI or 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. 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 (as indicated).

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Progressive resistance exercise (exercise group)

Standard of care (non-exercise group).

Arm Description

Subjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group)

Subjects will receive continuation of standard of care (non-exercise group).

Outcomes

Primary Outcome Measures

Brain effects measured with fMRI
To measure change in BOLD (fMRI) signals to functional connectivity in active group vs the control group.
Brain effects measured with TMS
To measure motor cortex excitability and plasticity in TMS findings.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2022
Last Updated
February 16, 2023
Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05663840
Brief Title
Effects of Exercise on Dystonia Pathophysiology
Official Title
Progressive Resistance Exercise and Dystonia Pathophysiology.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
December 31, 2027 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

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 in response to exercise training.
Detailed Description
Dystonia is a debilitating movement disorder. It involves involuntary muscle contractions with abnormal and repetitive movements, postures, or both. The current treatments for dystonia comprise of oral medications, botulinum toxin injections, and deep brain stimulation surgery. These treatments, despite optimal management, fail to improve symptoms in more than a third of patients and the improvements are often unpredictable. We will investigate the brain adaptation effects for progressive resistance exercise-focused cervical and shoulder training (PERFECT) in patients with focal cervical dystonia with functional MRI (fMRI) and transcranial magnetic stimulation (TMS) techniques for understanding the pathophysiology of dystonia and treatment related changes. The investigators propose to enroll patients with predominantly focal cervical dystonia and compare PERFECT plus standard-of-care (SOC) therapy (n = 27) with a control group of SOC therapy (n = 27). Participants in the PERFECT + SOC group will perform physical therapist-guided exercises twice a week for 6 months and participants in the SOC group will continue receiving standard pharmacological therapies at stable doses and they will not exercise.

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
Investigator
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progressive resistance exercise (exercise group)
Arm Type
Experimental
Arm Description
Subjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group)
Arm Title
Standard of care (non-exercise group).
Arm Type
Active Comparator
Arm Description
Subjects will receive continuation of standard of care (non-exercise group).
Intervention Type
Behavioral
Intervention Name(s)
Progressive resistance exercise
Intervention Description
Patients with predominant symptoms of cervical dystonia will receive exercise training. Patients will receive progressive resistance exercise focused cervical and shoulder training (PERFECT) plus standard-of-care (SOC) therapy. Resistance training will consist of mainly muscle-strengthening exercises for the neck, shoulder and arms and a few upper trunk muscles. Resistance training will be guided by physical therapists at twice a week schedule for 6 months. These participants will also receive SOC therapy.
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Subjects will receive SOC therapy only
Primary Outcome Measure Information:
Title
Brain effects measured with fMRI
Description
To measure change in BOLD (fMRI) signals to functional connectivity in active group vs the control group.
Time Frame
Baseline up to 6 months
Title
Brain effects measured with TMS
Description
To measure motor cortex excitability and plasticity in TMS findings.
Time Frame
Baseline up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have predominantly focal cervical dystonia and whose diagnosis will be confirmed by a movement disorders specialist following criteria recommended by Movement Disorders Society. Moderate disease severity. Are 30 to 85 years old Are able to tolerate exercise sessions. Reporting suboptimal clinical benefits despite receiving maximally tolerated doses of BoNT injections for the neck muscles and/or oral pharmacological therapy. Exclusion Criteria: Participating in an alternate structured exercise program, receiving regular physical or occupational therapy Have significant pain, spondylosis or active arthritis Fail the Physical Activity Readiness Questionnaire Have significant cognitive impairment Have implanted electrical device (eg, cardiac pacemaker or a DBS or a neurostimulator or metallic clip in their body, as necessitated by the risks of MRI or TMS Active seizure disorder; not be eligible for TMS and claustrophobic for MRI portion. As necessitated by the risks of MRI or 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. 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 (as indicated).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aparna Wagle Shukla, MD
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aparna Wagle Shukla, MD
Phone
352-273-5550
Email
aparna.shukla@neurology.ufl.edu
First Name & Middle Initial & Last Name & Degree
Aparna Wagle Shukla, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Exercise on Dystonia Pathophysiology

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