Exercise for Parkinson's Disease

(EXCEL-PD Trial)

Overseen By Nijee Luthra, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Neuroleptics, Antidepressants, Anxiolytics, others

Disqualifiers: Atypical parkinsonism, Cognitive impairment, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 26 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based exercise program to determine its effectiveness for people with Parkinson's disease. Researchers aim to discover whether combining endurance exercises, such as treadmill running, with resistance training can enhance movement and cognitive skills. Participants will exercise at home with virtual guidance from trainers, while the control group will maintain their usual activities. Individuals with Parkinson's who experience symptoms like tremors or stiffness and do not already exercise frequently might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how exercise can benefit those with Parkinson's.

Will I have to stop taking my current medications?

The trial requires that if you are taking Parkinson's disease medications, your doses must be stable for at least 2 months before starting. If you are not on these medications, you should not need them for the next 6 months. Other medications, like certain psychotropic drugs, need to have stable doses for at least 30 days before starting.

What prior data suggests that this exercise program is safe for people with Parkinson's disease?

Research has shown that exercise is generally safe for people with Parkinson's disease. Studies have found that physical activity can improve balance, movement, and flexibility, and it can also benefit non-motor symptoms like mood and sleep. However, the risk of negative effects, such as injuries, remains unclear, and researchers are not completely certain about the level of risk.

One study found that people with mild to moderate Parkinson's disease did not report any major safety concerns when participating in exercise programs. This suggests that exercise might be well-tolerated. Activities like walking on a treadmill, dancing, and tai chi have demonstrated positive effects on the disease's progression without major safety issues.

In summary, while exercise appears helpful and generally safe for people with Parkinson's, the exact risk of negative effects is uncertain. Participants should follow guidance from exercise trainers to minimize any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for Parkinson's, which often involve medications like levodopa or dopamine agonists to manage symptoms, this approach focuses on exercise as a therapeutic method. Researchers are excited because the exercise program combines endurance and resistance training, which could offer a natural way to improve motor function and overall health. Conducted at home with virtual supervision, this method provides flexibility and accessibility, potentially enhancing adherence and making it easier for patients to integrate into their daily lives.

What evidence suggests that exercise is effective for Parkinson's disease?

This trial will compare the effects of exercise with a waitlist control group for individuals with Parkinson's disease. Studies have shown that exercise can improve movement and reduce symptoms in people with Parkinson's disease. For example, aerobic and resistance training can enhance mobility and balance. Research also suggests that regular activity can lead to better long-term health for those with Parkinson's. Exercise has even been linked to improvements in mood and thinking skills. Overall, staying active appears to be a powerful way to help manage Parkinson's disease. ^{1 2 4 6 7}

Who Is on the Research Team?

Nijee Luthra, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with Parkinson's disease who are stable on their PD medications or unlikely to need them in the next 6 months. They should be able to follow exercise instructions without significant cognitive impairment (MoCA score ≥23) and not have severe depression (BDI ≤16). Participants must not have major cardiovascular, metabolic, renal diseases, or other conditions that would make exercising unsafe.

Inclusion Criteria

I have been diagnosed with Parkinson's disease, showing slow movement and either tremor or stiffness.

I am between 40 and 80 years old.

My Parkinson's disease is not in the most advanced stage.

Exclusion Criteria

You have a medical condition or injury that may make it difficult for you to exercise.

I have not used neuroleptics or dopamine blockers in the last 30 days.

I haven't been seriously ill or hospitalized in the last month.

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, trainer-supervised endurance and resistance training program for 26 weeks

26 weeks

Virtually supervised sessions 5 days per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants in the waitlist control group are offered the exercise program after the 26-week study period

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Exercise
• No Exercise

Trial Overview

The study tests a home-based exercise program using high intensity endurance and resistance training for those with Parkinson's. It looks at how this affects cognition and biological markers related to exercise. Some participants will do exercises while others won't, allowing comparison of effects.

How Is the Trial Designed?

Group I: Exercise Experimental Treatment 1 Intervention

Participants randomized to the exercise group will receive 26 weeks of home-based, combined endurance and resistance training program under guidance and virtual supervision from exercise trainers. Exercise will be performed 5 days per week, with 3 days of endurance training using treadmill and 2 days of resistance training.

Group II: Waitlist Control Group Placebo Group 1 Intervention

The control group will continue usual level of physical activity the participants were doing prior to enrollment in the study. At the end of the 26 week study period, participants will be offered the chance to participate in the same home-based, combined endurance and resistance training program.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Individuals with Parkinson disease (PD) who take at least 4200 steps daily are significantly more likely to meet physical activity guidelines, being 23 times more likely than those who take fewer steps.

High-intensity treadmill exercise effectively increases daily steps and moderate-to-vigorous physical activity in less active individuals with PD, but these increases do not correlate with improvements in fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in De Novo Parkinson Disease: Daily Step Recommendation and Effects of Treadmill Exercise on Physical Activity. Handlery, R., Stewart, JC., Pellegrini, C., et al.[2021]

Boxing exercises for people with Parkinson's disease (PD) showed potential benefits, including improved balance, mobility, and quality of life, based on two studies with 37 participants over 12 weeks, although the evidence is limited due to the small sample size.

Despite the growing popularity of boxing as an intervention for PD, the overall quality of supporting evidence is low, with many websites lacking verifiable data and safety guidelines, highlighting the need for more rigorous research and professional training for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boxing for Parkinson's Disease: Has Implementation Accelerated Beyond Current Evidence? Morris, ME., Ellis, TD., Jazayeri, D., et al.[2020]

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]

A review of seven studies indicates that physical exercise significantly improves physical performance and activities of daily living in patients with Parkinson's disease, including enhancements in strength, balance, and mobility.

The findings suggest a need for standardized exercise programs tailored to Parkinson's disease and longer-term studies to evaluate the sustainability of these improvements beyond the intervention period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is physical exercise beneficial for persons with Parkinson's disease? Crizzle, AM., Newhouse, IJ.[2006]

Both Tai Chi and combined stretching-strengthening exercises improved functional fitness in patients with mild-to-moderate Parkinson's disease after 8 weeks of training, compared to a control group that showed deterioration.

Tai Chi specifically enhanced the emotional quality of life for participants, while the combined stretching-strengthening exercise improved social quality of life, indicating that Tai Chi may be a particularly beneficial exercise strategy for improving overall well-being in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Exercise Programs for Parkinson's Disease: Tai Chi versus Combined Exercise. Cheon, SM., Chae, BK., Sung, HR., et al.[2021]

A case series involving six patients with Parkinson's disease showed that a boxing training program led to significant improvements in balance, mobility, and quality of life after 12 weeks, with continued benefits observed at 24 and 36 weeks.

The program was found to be safe and feasible, with patients experiencing greater improvements earlier if they had mild Parkinson's disease, while those with moderate to severe disease required longer training to achieve similar benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boxing training for patients with Parkinson disease: a case series. Combs, SA., Diehl, MD., Staples, WH., et al.[2022]

A systematic review of seven studies involving 401 participants with Parkinson's disease found that moderate intensity resistance training significantly improved muscle strength, balance, and motor symptoms after 8-10 weeks of training, with sessions occurring 2-3 times per week.

The effectiveness of resistance training was highlighted by a significant standardized mean difference (SMD) of 0.61 for muscle strength and 0.48 for motor symptoms, indicating that this type of exercise can be beneficial for individuals with early to moderate stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of resistance training on muscle strength and physical function in people with Parkinson's disease: a systematic review and meta-analysis. Chung, CL., Thilarajah, S., Tan, D.[2018]

A survey of 64 Parkinson's Disease patients revealed that 67% exercised at least twice a week, with walking being the most common form of exercise, and 97% reported improvements in their symptoms due to exercise.

Patients who exercised in groups experienced greater symptomatic improvements compared to those who exercised alone, highlighting the potential added benefits of social interaction and cognitive engagement in group activities like dance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Reported Exercise Trends in Parkinson's Disease Patients. Raje, P., Ning, S., Branson, C., et al.[2019]

In a 16-month study involving 121 individuals with Parkinson's disease, the flexibility/balance/function exercise (FBF) program showed significant improvements in overall physical function compared to a home-based control group at 4 months.

The supervised aerobic exercise (AE) program demonstrated better walking economy than the FBF program at multiple time points (4, 10, and 16 months), indicating its effectiveness in enhancing physical performance in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Schenkman, M., Hall, DA., Barón, AE., et al.[2022]

A 6-month community exercise program for people with Parkinson's disease was found to be safe, with high adherence rates (37 out of 53 participants) and no serious adverse events related to the exercise.

The exercise group showed positive effects on motor symptoms, with a small effect size for improvements in walking distance and overall motor function, suggesting potential long-term benefits of regular exercise for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease. Collett, J., Franssen, M., Meaney, A., et al.[2021]

Resistance training (RT) and endurance training (ET) are safe and feasible exercise modalities for people with Parkinson's disease, showing significant benefits in muscle strength, functional capacity, and quality of life based on a review of 33 new randomized controlled trials.

RT demonstrated a strong positive impact on muscle strength (SMD = 0.83) and functional capacity, while ET improved cardiorespiratory fitness (SMD = 0.27) and also showed potential benefits for functional outcomes, indicating that both types of exercise can be effective adjunct therapies for managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Gamborg, M., Hvid, LG., Dalgas, U., et al.[2022]

Exercise has numerous benefits for individuals with Parkinson's disease, helping to reduce disability and improve movement disorders.

This scoping review proposes specific exercise modalities, including Brazilian dance, deep-water exercises, and Nordic walking, along with walking tests to help therapists design effective exercise programs tailored for people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. Peyré-Tartaruga, LA., Martinez, FG., Zanardi, APJ., et al.[2022]

Forced exercise may serve as a safe additional therapy for improving motor function in individuals with Parkinson's Disease, complementing existing medical treatments.

While exercise enhances the effectiveness of anti-parkinsonian medications, it does not reduce their side effects, highlighting the need for alternative approaches like forced exercise to support patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effects of forced exercise cycling in individuals with Parkinson's disease. Miner, DG., Aron, A., DiSalvo, E.[2021]

The FIGHT-PD study demonstrated that a 15-week boxing training program for 10 participants with early-stage Parkinson's disease was highly feasible, with a 97.7% adherence rate and no withdrawals, indicating strong participant engagement and safety.

Nine out of ten participants showed improvement in their motor scores on the Unified Parkinson Disease Rating Scale (UPDRS-III), suggesting that boxing training may be an effective intervention for enhancing motor function in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FIGHT-PD: A feasibility study of periodized boxing training for Parkinson disease. Blacker, DJ., Fazio, R., Tucak, C., et al.[2023]

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Exercise for People with Parkinson's Disease

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Various exercises, including treadmill training, dance, and tai chi, have shown beneficial outcomes against PD progression; however, which ...