Recruiting

Exercise

Sponsor:

University of Florida

Code:

NCT05663840

Conditions

Dystonia

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Progressive resistance exercise

Standard of care

Study Details

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.

Conditions

Dystonia

Study ID

NCT05663840

Start date

Oct 13, 2022

Status verified date

Jun, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Progressive resistance exercise (exercise group)

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

active comparator: Standard of care (non-exercise group).

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

Interventions

Progressive resistance exercise

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.

Standard of care

Subjects will receive SOC therapy only

Primary outcome measure

  • Brain effects measured with fMRI [ Time Frame: Baseline up to 6 months ]
  • Brain effects measured with TMS [ Time Frame: Baseline up to 6 months ]

Central Contacts and Locations

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Aparna Wagle Shukla, MD

352-273-5550aparna.shukla@neurology.ufl.edu

Principal Investigator:

Aparna Wagle Shukla, MD

More Information

Sponsor

University of Florida

Last update posted

Jul 28, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-07-28.