56 Participants Needed

Exercise for Dystonia

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Florida
Must be taking: BoNT injections
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be receiving maximally tolerated doses of BoNT injections and/or oral therapy, suggesting you may continue these treatments.

What data supports the effectiveness of the treatment Progressive Resistance Training (PRT) for dystonia?

Research on Parkinson's disease, a condition with some similarities to dystonia, shows that Progressive Resistance Training (PRT) can help improve strength, balance, and movement. This suggests that PRT might also be beneficial for people with dystonia.12345

Is progressive resistance training safe for humans?

Progressive resistance training (PRT) has been studied in people with Parkinson's disease and cerebral palsy, and it is generally considered safe for these conditions. These studies suggest that PRT can be safely used as part of rehabilitation programs, although specific safety data for dystonia is not provided.23678

How is the treatment Progressive Resistance Exercise unique for dystonia?

Progressive Resistance Exercise (PRT) is unique because it focuses on gradually increasing the resistance or weight used during exercise, which can help improve muscle strength and function. This approach is different from other treatments for dystonia that may not specifically target muscle strength through resistance training.2391011

Research Team

AW

Aparna Wagle Shukla, MD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for individuals aged 30-85 with moderate cervical dystonia, confirmed by a specialist. They should be able to exercise but not currently in another structured program or receiving regular therapy. Participants must not have significant pain, arthritis, cognitive impairments, implanted electrical devices, active seizures, and women of childbearing age must pass pregnancy tests.

Inclusion Criteria

My condition is considered moderate in severity.
My condition is considered moderate in severity.
I haven't seen much improvement despite taking the highest safe doses of BoNT injections for my neck and/or oral medications.
See 6 more

Exclusion Criteria

You have major problems with your thinking and memory.
I am currently in a structured exercise program or receiving therapy.
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)
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the exercise group perform physical therapist-guided progressive resistance exercises twice a week for 6 months, while the control group continues standard pharmacological therapies.

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of brain effects using TMS and fMRI.

4 weeks

Treatment Details

Interventions

  • Progressive resistance exercise
  • Standard of care
Trial Overview The study is examining the effects of progressive resistance exercise compared to standard care on brain and motor behavior changes in people with dystonia. It aims to see if exercise can improve symptoms for those who haven't fully benefited from injections or oral medications.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Progressive resistance exercise (exercise group)Experimental Treatment1 Intervention
Subjects will receive physical therapy that will predominantly include progressive resistance exercise training program along with continuation of standard of care (exercise group)
Group II: Standard of care (non-exercise group).Active Control1 Intervention
Subjects will receive continuation of standard of care (non-exercise group).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Findings from Research

A systematic review of 11 studies on exercise interventions for Progressive Supranuclear Palsy (PSP) found that reporting quality was poor, with CERT scores ranging from 3 to 12 out of 19, indicating inadequate descriptions for replicating interventions.
While some aspects like exercise equipment and scheduling were well reported, critical elements such as instructor qualifications, safety measures, and adherence strategies were often unclear, suggesting a need for improved documentation in future studies.
Exercise and Progressive Supranuclear Palsy: the need for explicit exercise reporting.Slade, SC., Underwood, M., McGinley, JL., et al.[2020]
Progressive resistance training (PRT) significantly improves freezing of gait, muscular strength, and quality of life in patients with Parkinson's disease, based on a systematic review of 14 studies involving 761 participants.
While PRT showed positive effects, it did not significantly improve gait velocity, stride length, or balance as measured by the Berg Balance Scale, indicating that its benefits may be more focused on specific aspects of mobility and strength.
Effectiveness of Progressive Resistance Training in Parkinson's Disease: A Systematic Review and Meta-Analysis.Yang, X., Wang, Z.[2023]
A systematic review of 12 studies involving adults with Parkinson's disease found that progressive resistance training did not show significant improvements in key physical performance measures compared to other treatments or no treatment.
Despite nine of the studies having a low risk of bias, the pooled effect sizes for outcomes like walking speed and endurance were below the minimal clinical significance, indicating that progressive resistance training may not be superior to other forms of physical training in rehabilitation for Parkinson's disease.
Progressive resistance training in Parkinson's disease: a systematic review and meta-analysis.Saltychev, M., Bärlund, E., Paltamaa, J., et al.[2022]

References

Exercise and Progressive Supranuclear Palsy: the need for explicit exercise reporting. [2020]
Effectiveness of Progressive Resistance Training in Parkinson's Disease: A Systematic Review and Meta-Analysis. [2023]
Progressive resistance training in Parkinson's disease: a systematic review and meta-analysis. [2022]
Autogenic training shows short-term benefits in patients with early Parkinson's disease. [2019]
Power vs strength training to improve muscular strength, power, balance and functional movement in individuals diagnosed with Parkinson's disease. [2020]
What are the optimum training parameters of progressive resistance exercise for changes in muscle function, activity and participation in people with cerebral palsy? A systematic review and meta-regression. [2023]
Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. [2022]
Neurorehabilitation with versus without resistance training after botulinum toxin treatment in children with cerebral palsy: a randomized pilot study. [2012]
Effects of moderate-volume, high-load lower-body resistance training on strength and function in persons with Parkinson's disease: a pilot study. [2021]
Cardiovascular, perceived exertion and affective responses during aerobic exercise performed with imposed and a self-selected intensity in patients with Parkinson's disease. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Periodized Resistance Training With and Without Functional Training Improves Functional Capacity, Balance, and Strength in Parkinson's Disease. [2023]
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