Exercise for Dystonia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: BoNT injections

Disqualifiers: Significant pain, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

56 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 9 10 11}

Who Is on the Research Team?

Aparna Wagle Shukla, MD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Progressive resistance exercise (exercise group) Experimental Treatment 1 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 Control 1 Intervention

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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive resistance training in Parkinson's disease: a systematic review and meta-analysis. Saltychev, M., Bärlund, E., Paltamaa, J., et al.[2022]

In a trial involving participants with early Parkinson's disease, those who received an additional 15 minutes of autogenic training alongside physiotherapy showed potential benefits compared to those who only had physiotherapy.

The study included 32 participants in the physiotherapy group and a similar number in the autogenic training group, suggesting that incorporating mental relaxation techniques may enhance the effects of physical therapy in managing Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autogenic training shows short-term benefits in patients with early Parkinson's disease. Sander, R.[2019]

In a study of 35 individuals with mild to moderate Parkinson's disease, both high-load strength training (ST) and low-load power training (PT) significantly improved muscular strength and power after 12 weeks of training, indicating their efficacy in addressing neuromuscular deficits associated with the disease.

Despite improvements in strength and power, neither training method led to significant enhancements in balance or functional movement, suggesting that while these interventions are beneficial for strength, they may not directly translate to better functional performance in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Power vs strength training to improve muscular strength, power, balance and functional movement in individuals diagnosed with Parkinson's disease. Cherup, NP., Buskard, ANL., Strand, KL., et al.[2020]

Progressive resistance exercise (PRE) is safe and effectively increases muscle strength in young people with cerebral palsy, with improvements maintained for an average of 11 weeks after training cessation, based on a meta-analysis of 16 randomized controlled trials involving 504 participants.

The study found inconclusive evidence regarding PRE's effects on gross motor function and participation, and no significant differences in muscle strength were observed based on the intensity or volume of the exercise program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Bania, TA., Taylor, NF., Chiu, HC., et al.[2023]

A 9-week progressive resistance training program significantly reduced bradykinesia and improved functional performance in 40 individuals with mild to moderate Parkinson's Disease, as evidenced by improvements in various functional tests.

The training group showed marked enhancements in mobility and strength compared to a control group that did not participate in the training, highlighting the potential of resistance training as a beneficial therapy for managing Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. Vieira de Moraes Filho, A., Chaves, SN., Martins, WR., et al.[2022]

In a study involving 14 children with cerebral palsy, both progressive resistance training (PRT) and conventional rehabilitation (CON) improved ankle muscle control after treatment with botulinum toxin type A, particularly by reducing antagonist muscle co-activity.

However, only the PRT group showed a significant increase in maximal plantarflexion torque, highlighting the added benefits of resistance training in enhancing muscle strength following BoNT treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurorehabilitation with versus without resistance training after botulinum toxin treatment in children with cerebral palsy: a randomized pilot study. Bandholm, T., Jensen, BR., Nielsen, LM., et al.[2012]

An 8-week resistance training program significantly improved maximum leg press strength relative to body mass in 18 individuals with Parkinson's disease, indicating enhanced lower-body strength (P < .05).

The training involved moderate volume, high-load exercises performed twice weekly, demonstrating that this type of resistance training can be beneficial for strength and function in people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of moderate-volume, high-load lower-body resistance training on strength and function in persons with Parkinson's disease: a pilot study. Schilling, BK., Pfeiffer, RF., Ledoux, MS., et al.[2021]

In a study involving 20 patients with Parkinson's disease, both traditional aerobic exercise and self-selected intensity (SSI) exercise resulted in similar cardiovascular responses, with no significant differences in heart rate or blood pressure during the sessions.

The perceived exertion and affective responses were also comparable between the two exercise methods, suggesting that SSI can be as effective as traditional exercise in managing cardiovascular health in Parkinson's disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular, perceived exertion and affective responses during aerobic exercise performed with imposed and a self-selected intensity in patients with Parkinson's disease. Kanegusuku, H., Correia, MA., Longano, P., et al.[2021]

A study involving 35 individuals with Parkinson's disease showed that both periodized resistance training with functional exercises and traditional resistance training significantly improved functional capacity, balance, and strength over 12 weeks.

The group that included functional training specifically showed improvements in freezing of gait, while traditional resistance training led to notable improvements in motor symptoms, suggesting tailored exercise programs can effectively address different challenges faced by individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodized Resistance Training With and Without Functional Training Improves Functional Capacity, Balance, and Strength in Parkinson's Disease. Strand, KL., Cherup, NP., Totillo, MC., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Exercise and Progressive Supranuclear Palsy: the need for explicit exercise reporting. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Progressive Resistance Training in Parkinson's Disease: A Systematic Review and Meta-Analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Progressive resistance training in Parkinson's disease: a systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Autogenic training shows short-term benefits in patients with early Parkinson's disease. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Power vs strength training to improve muscular strength, power, balance and functional movement in individuals diagnosed with Parkinson's disease. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Neurorehabilitation with versus without resistance training after botulinum toxin treatment in children with cerebral palsy: a randomized pilot study. [2012]

9. United States pubmed.ncbi.nlm.nih.gov

Effects of moderate-volume, high-load lower-body resistance training on strength and function in persons with Parkinson's disease: a pilot study. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Periodized Resistance Training With and Without Functional Training Improves Functional Capacity, Balance, and Strength in Parkinson's Disease. [2023]