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?

This trial explores how exercise can change brain and motor functions in people with dystonia, a muscle disorder causing involuntary movements. Participants will either continue their regular treatment or add progressive resistance exercises, which gradually increase in intensity, to determine if this improves their condition. The trial seeks individuals with moderate cervical dystonia (muscle spasms in the neck) who haven't found full relief from current treatments. As an unphased trial, it offers a unique opportunity to contribute to understanding how exercise might benefit those with dystonia.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that progressive resistance exercise is generally safe for many individuals, even those with certain health conditions. Studies indicate that these exercises typically don't cause problems and are often easy to manage. For instance, individuals with chronic obstructive pulmonary disease (a lung condition) have safely used these exercise programs without issues. Additionally, progressive resistance exercise has proven beneficial for people with Parkinson's disease, provided they don't have severe symptoms or other health complications. While specific safety data for individuals with dystonia is lacking, current evidence suggests that this type of exercise is likely safe and manageable for many. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using progressive resistance exercise for treating dystonia because it offers a non-drug approach that could enhance physical function. Unlike traditional treatments for dystonia, which often rely on medications like anticholinergics or botulinum toxin injections to manage symptoms, progressive resistance exercise focuses on building muscle strength and improving motor control. This method could potentially empower patients to take an active role in their treatment and improve their quality of life by reducing muscle spasms and increasing overall mobility. Additionally, exercise as a treatment has minimal side effects compared to medication, making it a promising complementary approach.

What evidence suggests that this trial's treatments could be effective for dystonia?

Research has shown that progressive resistance exercise, which participants in this trial may receive, can benefit people with certain movement disorders. Studies have found that this type of exercise improves strength and balance in people with Parkinson's disease, which shares some movement issues with dystonia. In one study, patients who performed these exercises reported feeling less tired and having stronger muscles. Although specific data on dystonia is limited, these benefits suggest that progressive resistance exercise might also help people with dystonia improve movement. Overall, strong evidence supports the potential of this exercise to help manage symptoms. ^{1 3 4 6 7}

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.

You are not physically ready for the study based on a questionnaire about your activity level.

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 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]

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 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 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]

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]

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]

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]

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]

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 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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20543732/

The effect of autoregulatory progressive resistance ... Our findings indicate that the APRE was more effective than the LP means of programming in increasing the bench press and squat over a period of 6 weeks.

2. academic.oup.com academic.oup.com/ptj/article/85/11/1208/2805087

Progressive Resistance Exercise in Physical Therapy The purpose of this article is to review the evidence on positive and negative effects of PRE as a physical therapy intervention.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7270996/

Evidence of Rehabilitative Impact of Progressive Resistance ... These results suggest that progressive resistance exercises can be effective in PD patients who lack comorbidities and severe disability. ...

4. researchgate.net researchgate.net/publication/341676854_Evidence_of_Rehabilitative_Impact_of_Progressive_Resistance_Training_PRT_Programs_in_Parkinson_Disease_An_Umbrella_Review

Parkinson's Disease - Resistance Training Progressive resistance training (PRT) improves strength, balance, and functional abilities. This umbrella review examines the efficacy of PRT ...

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-08994-x

Effectiveness of a progressive resistance exercise program for ... The primary outcome measures were perceived fatigue control and maximum muscle strength, measured through the Need for Recovery Scale and one- ...

6. evolutionsportspt.com evolutionsportspt.com/autoregulatory-progressive-resistance-exercise-apre

Autoregulatory Progressive Resistance Exercise (APRE) This style of training is superior to a traditional linear based program because it auto-regulates the program based on how the athlete is feeling that day.

7. researchgate.net researchgate.net/publication/44669057_The_Effect_of_Autoregulatory_Progressive_Resistance_Exercise_vs_Linear_Periodization_on_Strength_Improvement_in_College_Athletes

(PDF) The Effect of Autoregulatory Progressive Resistance ... This study examined whether 6 weeks of APRE was more effective at improving strength compared with traditional LP in division I College football players.