Telemedicine Intervention for Chronic Pain in Parkinson's Disease

Overseen By David W Sparrow, DSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Dopaminergic medication

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: 3 months

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how home-based physical and mental exercises can reduce pain for people with Parkinson's disease, a condition where pain is common but often untreated. Participants will be divided into groups to receive either physical exercises, cognitive exercises, both types, or health education over three months. The goal is to find easy and affordable ways to manage pain through remote access, especially for Veterans with Parkinson's. The trial seeks participants diagnosed with Parkinson's who experience symptoms like tremors or stiffness. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance pain management strategies for Parkinson's patients.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves exercise interventions and not medication changes, you may not need to stop your current medications.

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

Research has shown that mental exercises at home are safe and enjoyable for people with Parkinson's. Studies found that participants safely performed these exercises at home, enjoyed them, and improved their thinking skills.

For physical exercise, research indicates it is safe and beneficial for people with Parkinson's. Home exercise programs did not cause serious side effects. These exercises help improve balance and walking speed, making daily tasks easier.

When combining physical and mental exercises, studies suggest this approach is safe and might enhance brain function more than doing each type alone. This combination is well-tolerated and can lead to better management of Parkinson's symptoms.

Overall, these treatments have demonstrated safety, with no major negative effects reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telemedicine interventions for chronic pain in Parkinson's disease because they offer a unique approach compared to standard treatments like medication and physical therapy. Unlike traditional methods, these interventions use cognitive and physical exercises that can be done remotely, making them accessible to more patients. The combination of cognitive and physical exercises aims to address both the mental and physical aspects of chronic pain, potentially offering a more holistic and convenient way to manage symptoms. This approach could revolutionize how patients interact with their treatment plans, providing flexibility and enhancing their quality of life.

What evidence suggests that this trial's treatments could be effective for chronic pain in Parkinson's disease?

Research has shown that home exercises can benefit people with Parkinson's disease by improving movement, thinking skills, and overall quality of life. In this trial, participants may receive a cognitive exercise intervention, which studies have found can be done remotely and might help slow memory and thinking problems. Others may receive a physical exercise intervention, which can increase strength, improve balance, and boost overall health. Some participants will receive both physical and cognitive exercises together, potentially leading to significant improvements in both body and mind. This evidence suggests that these exercises, whether done separately or together, can help manage ongoing pain and other symptoms of Parkinson's disease. ^{1 6 7 8 9}

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 individuals with Parkinson's Disease who experience chronic pain. Participants must have a physician's diagnosis of idiopathic PD, show at least two key symptoms (resting tremor, rigidity, or slow movement), and respond to medication that increases dopamine. It excludes those with recent heart issues like angina or myocardial infarction within the last six months.

Inclusion Criteria

My condition improves with dopamine medication.

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

I show at least 2 key symptoms of Parkinson's disease.

Exclusion Criteria

I am currently being treated for irregular heartbeats.

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

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 either cognitive exercise, physical exercise, combined interventions, or health education for 3 months

3 months

Remote access technology used for interventions

Follow-up

Participants are monitored for changes in pain severity after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive exercise intervention
• Health education
• Physical exercise intervention

Trial Overview

The study tests home-based physical and cognitive exercises along with health education as interventions to reduce pain in Parkinson's patients using telemedicine. This could help veterans maintain these practices indefinitely through remote access technology.

How Is the Trial Designed?

Group I: Physical exercise intervention Experimental Treatment 1 Intervention

Participants will receive the physical exercise intervention for 3 months.

Group II: Combined physical and cognitive exercise intervention Experimental Treatment 2 Interventions

Participants will receive both the physical exercise intervention and the cognitive exercise intervention for 3 months.

Group III: Cognitive exercise intervention Experimental Treatment 1 Intervention

Participants will receive the cognitive exercise intervention for 3 months.

Group IV: Control group Active Control 1 Intervention

Participants will receive health education for 3 months.

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

In a study of 58 participants with Parkinson's disease, individualized physical therapy significantly improved physical performance and balance compared to home exercise programs and group classes, highlighting the importance of supervision in exercise interventions.

While group classes enhanced gait performance, the home exercise program was the least effective overall, especially for individuals with comorbidities, suggesting that tailored, supervised exercise is crucial for maximizing benefits in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. King, LA., Wilhelm, J., Chen, Y., et al.[2018]

A home-based exercise program with telephonic coaching was developed for older adults with Motoric Cognitive Risk syndrome, showing that this approach is safe and feasible for promoting exercise participation.

The program had no adverse effects, and participants rated it highly, indicating that personalized and supervised exercise can effectively overcome barriers to physical activity in cognitively impaired individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise program for older adults with Motoric Cognitive Risk syndrome: feasibility study. Ambrose, AF., Gulley, E., Verghese, T., et al.[2021]

Telerehabilitation is a feasible and effective option for managing both motor symptoms (like gait and balance) and non-motor symptoms (such as speech disorders) in patients with Parkinson's disease, based on a systematic review of 15 studies involving 421 patients.

The review also indicated that telerehabilitation can improve quality of life and patient satisfaction, suggesting it is a valuable alternative to traditional in-person therapy for those with limited access to specialist care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Telerehabilitation on Motor Impairments, Non-motor Symptoms and Compliance in Patients With Parkinson's Disease: A Systematic Review. Vellata, C., Belli, S., Balsamo, F., et al.[2021]

A digital, home-based exercise program for 16 patients with Parkinson's disease showed high adherence (74.5%) and excellent usability, indicating that patients found the smartphone app easy to use and beneficial for their training.

After 6-8 months, patients using the app experienced improvements in their daily motor activities, while the control group showed a decline in motor function, suggesting that this digital exercise approach can effectively complement traditional medical treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an individualized smartphone-based exercise program on self-defined motor tasks in Parkinson's disease: a long-term feasibility study. Lützow, L., Teckenburg, I., Koch, V., et al.[2023]

The STEPS trial will evaluate the effectiveness of a 10-week eHealth-supported motor-cognitive training program for 120 participants with mild to moderate Parkinson's disease, focusing on improving walking capacity compared to a standard paper-based exercise program.

The primary outcome measured will be walking capacity using the six-minute walk test, with additional assessments on gait performance, mobility, and patient-reported outcomes, aiming to provide evidence for the efficacy of eHealth interventions in managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the STEPS trial: a phase II randomized controlled trial evaluating eHealth-supported motor-cognitive home training for Parkinson's disease. Leavy, B., Sedhed, J., Kalbe, E., et al.[2023]

A study involving 57 participants in a supervised, home-based telerehabilitation program for 10 months showed that this approach effectively preserved quality of life and walking ability in people with Parkinson's disease during social distancing.

In contrast, a nonexercising control group of 29 participants experienced worsening in all assessed clinical aspects, highlighting the benefits of continued exercise through telerehabilitation for frequent exercisers with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation during social distancing for people with Parkinson's disease: a retrospective study. Tardelli, E., Moreira-Neto, A., Okamoto, E., et al.[2023]

A telerehabilitation protocol involving 40 participants with mild to moderate Parkinson's disease was successfully implemented, demonstrating its feasibility and effectiveness as an alternative to in-person physical therapy during the COVID-19 pandemic.

The intervention included 20 remote weekly sessions focusing on physical and cognitive training, which helped minimize negative impacts on functional strength, quality of life, and mental health in patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth For Individuals with Parkinson's Disease During Covid-19 In Brazil: A Prospective Case Series. Barboza, NM., de Oliveira Araújo, HAG., Terra, MB., et al.[2023]

A novel telerehabilitation program using a treadmill-virtual reality system for patients with Parkinson's disease showed high adherence to training and significant improvements in walking duration, gait speed, and overall mobility over a year-long period.

The program allowed simultaneous training of two patients at home, which not only enhanced individual treatment but also saved time for therapists, making it a practical solution for maintaining exercise adherence during challenges like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-Rehabilitation with Virtual Reality: A Case Report on the Simultaneous, Remote Training of Two Patients with Parkinson Disease. Cornejo Thumm, P., Giladi, N., Hausdorff, JM., et al.[2023]

A telerehabilitation program for Parkinson's disease was found to be feasible and effective, showing high adherence and minimal adverse effects among 19 participants in the Brazilian Amazon over a 4-week period.

Both the telerehabilitation and a control booklet-based exercise program improved participants' performance on the Timed Up and Go test, indicating that remote physiotherapy can be a valuable alternative for those with limited access to traditional rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of a remote individual rehabilitation program for people with Parkinson's disease living in the Brazilian Amazon: a randomized clinical trial. Pastana Ramos, LF., Vilacorta-Pereira, TCS., Duarte, JDS., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11754226/

Effectiveness of a home-based computerized cognitive ...

This study aimed to assess the effectiveness of a Home-Based Computerized Cognitive Training (HB-CCT) program in individuals with PD using a pilot randomized ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10250101/

Efficacy and Feasibility of Remote Cognitive Remediation ...

This randomized controlled pilot study suggests that remote CRT for PD patients is feasible, enjoyable, and may help slow the progression of cognitive decline.

3.

withpower.com

withpower.com/trial/phase-parkinsons-disease-pd-2023-888a6

Telemedicine Intervention for Chronic Pain in Parkinson's ...

Research shows that home-based physical and cognitive exercises, supported by telehealth, can improve motor skills, cognitive function, and quality of life in ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1353802023009872

Effects of physical exercise interventions on cognitive ...

A recent meta-analysis found that physical exercise significantly improved attention and working memory but not global cognition and executive function in ...

5.

ptj.uswr.ac.ir

ptj.uswr.ac.ir/article-1-689-en.pdf

Effectiveness of Cognitive Behavioral Therapy and Aerobic ...

Results: Cognitive behavioral therapy demonstrated a significantly greater improvement in cognitive functions than aerobic exercise (P<0.001), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10996106/

Feasibility of a novel eHealth intervention for Parkinson's ...

This motor-cognitive eHealth home exercise intervention for PD was safe and feasible in terms of Recruitment capability, Acceptability, Safety and Demand.

7.

frontiersin.org

frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1531688/full

Effectiveness of a home-based computerized cognitive ...

This study aimed to assess the effectiveness of a Home-Based Computerized Cognitive Training (HB-CCT) program in individuals with PD using a pilot randomized ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01156714

Exercise and Cognitive Training in Parkinson's Disease

This study compares the effects treadmill exercise, computerized cognitive training, or the combination of the two on executive function, dual-task performance, ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1568163722001131

Computerized cognitive training in Parkinson's disease

Our findings suggest that CCT is associated with cognitive benefits in PD, including when delivered remotely.