Trials / Recruiting
RecruitingNCT05663840
Effects of Exercise on Dystonia Pathophysiology
Progressive Resistance Exercise and Dystonia Pathophysiology.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 56 (estimated)
- Sponsor
- University of Florida · Academic / Other
- Sex
- All
- Age
- 30 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | Standard of care | Subjects will receive SOC therapy only |
Timeline
- Start date
- 2022-10-13
- Primary completion
- 2027-12-31
- Completion
- 2027-12-31
- First posted
- 2022-12-23
- Last updated
- 2025-07-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05663840. Inclusion in this directory is not an endorsement.