Speech and Exercise Therapy for Parkinson's Disease

Overseen By Niquel Ortega

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Dopaminergic

Disqualifiers: Angina, Recent MI, Ventricular dysrhythmia

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combined speech and exercise program can improve speech clarity for people with Parkinson's disease. The researchers aim to find a cost-effective way to enhance communication abilities using remote technology, which may particularly benefit Veterans. Participants should have Parkinson's disease with speech difficulties and respond well to Parkinson's medication. This study could lead to better care options for those struggling with speech issues due to Parkinson's.

As an unphased trial, it offers participants the chance to contribute to innovative research that could significantly enhance communication for those with Parkinson's.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications. However, since participants must respond to dopaminergic medication, it seems likely you will continue taking it.

What prior data suggests that this combined speech and exercise intervention is safe for people with Parkinson's disease?

Research has shown limited clear information on the safety of combining speech and exercise therapy for Parkinson’s disease. A review of studies found that many did not mention side effects, complicating a full understanding of safety. However, speech therapy is commonly used for Parkinson's disease, and exercise is generally safe.

One study found that speech therapy might help with speech problems in Parkinson’s disease, but the evidence was not strong. Despite the lack of specific safety details, this type of therapy is often well-tolerated, involving non-invasive activities like speech exercises and physical movements.

Overall, while specific safety data remains limited, speech and exercise therapy are generally low-risk and commonly used to help manage Parkinson's disease symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined speech and exercise intervention for Parkinson's Disease because it offers a unique, home-based approach that blends physical activity with speech improvements. Unlike traditional treatments that typically focus on medication to manage symptoms, this intervention uses interactive automated speech response features to actively engage patients and enhance speech performance. This innovative method not only aims to improve motor skills through exercise but also targets speech, which is often affected in Parkinson's patients, potentially providing a more comprehensive improvement in quality of life.

What evidence suggests that this combined speech and exercise intervention is effective for Parkinson's disease?

Research has shown that combining speech and exercise therapy, which participants in this trial may receive, can help people with Parkinson's disease improve their speech. Studies have found that this therapy boosts communication quality, speech clarity, and overall speech function. For instance, one study reported significant improvements in voice and speech after incorporating music into the therapy. Another study demonstrated that remotely delivered speech therapy effectively enhances speech performance. These findings suggest that this approach might help people with Parkinson's speak more clearly and communicate better. ^{2 3 5 6 7}

Who Is on the Research Team?

David William Sparrow, DSc

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who have speech and voice disorders known as hypokinetic dysarthria. Participants must have a diagnosis of idiopathic PD, show at least two key symptoms (resting tremor, rigidity, bradykinesia), and respond to medication for PD. Those with recent heart issues or requiring therapy for irregular heartbeat cannot join.

Inclusion Criteria

I have a speech disorder due to muscle weakness.

My condition improves with dopamine medication.

I have been diagnosed with Parkinson's disease by a doctor.

Exclusion Criteria

I have had a heart attack in the last 6 months.

I am currently being treated for irregular heartbeats.

I have chest pain due to heart problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a home-based exercise intervention with interactive automated speech response features or a health education program

6 months

Remote sessions

Follow-up

Participants are monitored for changes in speech intelligibility and self-perceived communication ability

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Combined speech and exercise intervention
• Health education

Trial Overview The study is testing if a combined speech and exercise program can help improve how well people with Parkinson's can speak and be understood. It compares this approach to standard health education. The intervention will be delivered through telemedicine, which could make long-term care more accessible.

How Is the Trial Designed?

Group I: Combined speech and exercise intervention Experimental Treatment 1 Intervention

Home-based exercise intervention with interactive automated speech response features that encourage a higher level of speech performance.

Group II: Control group Active Control 1 Intervention

Health education

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Task-specific training with perturbations has been shown to effectively improve gait and balance in people with Parkinson's disease, potentially reducing the risk of falls, based on initial randomized controlled trials.

Combining task-specific training with cardiovascular exercise may enhance neuroplasticity, leading to better therapy outcomes, although the current quality of evidence for these approaches is still low and more rigorous studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New approaches in exercise therapy for Parkinson's disease]. Wanner, P., Klamroth, S., Steib, S.[2022]

Recent advances in neuroscience have improved understanding of how rehabilitation and exercise can benefit individuals with Parkinson's disease (PD), leading to more referrals for early and continuous exercise programs.

The article highlights the Lee Silverman Voice Treatment as an effective speech therapy for PD, documenting its efficacy and unexpected outcomes, while also exploring the underlying mechanisms of speech disorders in PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive voice treatment in Parkinson's disease: Lee Silverman Voice Treatment. Sapir, S., Ramig, LO., Fox, CM.[2022]

Exercise is a crucial part of managing Parkinson's disease (PD) and is shown to improve physical fitness, but there is a lack of standardized recommendations due to the variability in exercise interventions across 83 clinical trials.

The most common exercise prescription found was multimodal exercise for 60 minutes, twice a week over 12 weeks, highlighting the need for increased physical activity levels as an effective strategy for PD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Exercise, and Physiotherapy in Parkinson's Disease: Defining the Concepts. Bouça-Machado, R., Rosário, A., Caldeira, D., et al.[2022]

Community-based exercise programs for individuals with Parkinson's disease (PD) show promise in improving health outcomes, but there is significant variability in the types of exercises and study designs used in the research.

While the feasibility and potential benefits of these programs are encouraging, the overall quality of the studies needs to be enhanced to better understand how different exercise modalities can support self-management in PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Made Accessible: the Merits of Community-Based Programs for Persons with Parkinson's Disease. Langbroek-Amersfoort, A., Schootemeijer, S., Bouten, L., et al.[2023]

Recent high-level studies indicate that targeted physical training, including strength and endurance exercises, can significantly improve mobility and balance in Parkinson's disease patients.

Speech therapy, particularly the Lee Silverman Voice Treatment, has been effective in addressing speech issues in Parkinson's patients, but further research is needed to confirm the benefits of other therapies like occupational and swallowing therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical, occupational, speech and swallowing therapies and physical exercise in Parkinson's disease. Ransmayr, G.[2022]

Out of 236 clinical trials on exercise therapy for Parkinson's disease, only 29.7% reported their findings, and just 25.8% had results published in scientific journals, indicating a significant gap in the dissemination of research outcomes.

Most trials exhibited unclear risks of bias and lacked essential methodological details, such as randomization and blinding, which undermines the reliability of their findings and highlights the need for higher quality reporting in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting and methodological quality of clinical trials on exercise therapy for Parkinson's disease. Silva, CM., Travessa, AM., Bouça-Machado, R., et al.[2020]

Exercise and rehabilitation programs become essential for Parkinson's disease patients when motor decline occurs despite DOPAtherapy, as they can help reduce daily life disability rather than directly improving core symptoms like bradykinesia or tremor.

Only a few well-designed studies exist on the effectiveness of rehabilitation in Parkinson's disease, but they suggest that early intervention with physiotherapy focusing on postural control and fall prevention can significantly benefit patients' independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercices program and rehabilitation of motor disorders in Parkinson's disease]. Pélissier, J., Pérennou, D.[2006]

A review of 53 randomized controlled trials on exercise and motor training for Parkinson's disease showed that most interventions were effective and well-supervised, lasting an average of 8.3 weeks, with high participant retention rates (69% retained ≥85% of participants).

However, the lack of detailed reporting on adherence and adverse events in 72% of trials may hinder clinicians' ability to implement these programs effectively in practice, as they need to weigh the benefits against potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Allen, NE., Sherrington, C., Suriyarachchi, GD., et al.[2021]

In a randomized controlled trial involving Parkinson's disease patients at Hoehn Yahr stage II, physiotherapy (PT) significantly improved functional outcomes, as indicated by a 3-point increase in FIM scores and better performance on the TUG test compared to general exercise (GE).

The UPDRS scores also showed a notable improvement in the PT group, with a 6.5-point difference at the end of treatment and an 11-point difference at follow-up, suggesting that physiotherapy is more effective than general exercise for managing symptoms in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Therapy Versus a General Exercise Programme in Patients with Hoehn Yahr Stage II Parkinson's Disease: A Randomized Controlled Trial. Dipasquale, S., Meroni, R., Sasanelli, F., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024004024

Articles Effectiveness of remotely delivered speech therapy ... The combined evidence suggests that speech therapy can improve communication-related quality of life of people with PD, and also speech quality and functional ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10754544/

Effects of stepped speech rehabilitation and psychological ... Overall, both groups demonstrated significant improvements in mFDA levels after 7 weeks of training, suggesting that speech rehabilitation ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37282797/

Voice improvement following conventional speech therapy ... This study aimed to examine the effects of a new tele-rehabilitation program, a combining of conventional speech therapy and singing intervention, on voice ...

4. withpower.com withpower.com/trial/phase-dysarthria-6-2021-ace1a

Speech and Exercise Therapy for Parkinson's Disease This study will test the hypothesis that a combined speech and exercise intervention will improve speech intelligibility in people with Parkinson's disease and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04966689

The Effect of Combined Speech and Music-therapy on ... The aim of this study will to investigate the possible changes in the voice and speech features in people with PD after a combined speech and music therapy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6261685/

Speech treatment in Parkinson's disease - PubMed Central This randomized controlled trial evaluated two speech treatments for PD matched in intensive dosage and high‐effort mode of delivery.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8678920/

Evidence for Early and Regular Physical Therapy and ... In this review, we present the evidence revealing early disability in PD and the effectiveness of physical therapy and exercise.