High-Intensity Treadmill Exercise for Parkinson's Disease

(SPARX3 Trial)

Recruiting at 30 trial locations

Overseen By Un Kang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: PD medications, Neuroleptics, Psychotropics, others

Disqualifiers: Cardiovascular, Metabolic, Renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

370 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different levels of treadmill exercise might slow the progression of Parkinson's disease symptoms in individuals diagnosed within the last three years who aren't yet on medication. Participants will walk on a treadmill four times a week at either moderate or high intensity. The study aims to determine if exercise can help manage the physical signs of Parkinson's. It suits those recently diagnosed with Parkinson's, who aren't taking medication, and can commit to regular treadmill sessions. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on non-medication-based interventions for Parkinson's.

Will I have to stop taking my current medications?

Yes, if you are currently taking medications for Parkinson's disease, you will need to stop them to participate in this trial. The study excludes anyone who has used Parkinson's medications like levodopa or dopamine agonists in the 60 days before the trial starts.

What prior data suggests that this treadmill exercise is safe for Parkinson's patients?

Research shows that using a treadmill is generally safe for people with Parkinson's disease. Studies have found that both high and moderate-intensity treadmill exercises can improve fitness and slow the disease's progression. For instance, a study in JAMA Neurology found that regular high-intensity treadmill exercise might slow Parkinson’s progression.

Another review confirmed that treadmill training improves balance and movement in people with Parkinson's. Importantly, these studies reported no major safety issues or side effects, making treadmill exercise a well-tolerated option for managing Parkinson's symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using high-intensity treadmill exercise for Parkinson's disease because it offers a non-drug approach that may improve symptoms through physical activity. Unlike traditional treatments like medication or surgery, which aim to manage symptoms chemically or mechanically, this method leverages the body's natural response to exercise. The high-intensity regimen, pushing patients to 80-85% of their maximum heart rate, could potentially enhance motor function and overall physical health more effectively than moderate or low-intensity exercise. By focusing on cardiovascular fitness, this approach may also improve quality of life and reduce the need for more invasive interventions.

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

Research shows that high-intensity treadmill exercise can benefit people with Parkinson's Disease. Studies suggest this exercise might slow the disease's progression and improve balance, walking speed, and movement control. One study found that intense workouts protect brain cells that produce dopamine, crucial for movement. Another study confirmed that treadmill training enhances walking and mobility. In this trial, participants will join either high-intensity or moderate-intensity treadmill exercise groups. Both exercise intensities can positively impact heart health in people with Parkinson’s. ^{1 2 3 5 6}

Who Is on the Research Team?

Daniel M Corcos, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for people aged 40-80 with early-stage Parkinson's disease (diagnosed within the last 3 years and not severe), who haven't started medication. They must have a positive DaTscan, be able to exercise, and not have other serious health issues or recent use of certain medications that could interfere with the study.

Inclusion Criteria

My condition was diagnosed less than 3 years ago.

My Parkinson's disease is in the early or mid-stage.

I am between 40 and 80 years old.

Exclusion Criteria

I am currently breastfeeding, pregnant, or plan to be pregnant soon.

I have heart, metabolism, or kidney issues without clearance for exercise.

My dose of mental health medication has been stable for the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in treadmill exercise 4 times per week at either 60-65% HRmax or 80-85% HRmax

12 months

Regular exercise sessions

Follow-up

Participants are monitored for changes in motor symptoms, quality of life, and other health metrics

6 months

Exploratory

Assessment of the sustainability and durability of exercise effects after removal of study support

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Treadmill walking

Trial Overview

The study tests if high-intensity treadmill exercise can slow down Parkinson's symptoms over a year. Participants are randomly placed in two groups: one does moderate-intensity workouts, while the other does high-intensity workouts, both four times per week.

How Is the Trial Designed?

Group I: High Intensity Exercise Experimental Treatment 1 Intervention

Treadmill exercise 4x per week at 80-85% HRmax.

Group II: Moderate Intensity Exercise Active Control 1 Intervention

Treadmill exercise 4x per week at 60-65% HRmax.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

The Parkinson Study Group

Collaborator

Trials

17

Recruited

32,500+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Treadmill training (TT) has shown immediate benefits for patients with Parkinson's disease, such as improved walking speed and stride length after just one session, with effects lasting for at least 15 minutes.

Long-term studies indicate that TT is feasible, safe, and effective in enhancing gait and overall quality of life for patients, suggesting potential positive changes in brain function, but more high-quality research is needed to firmly establish these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training for the treatment of gait disturbances in people with Parkinson's disease: a mini-review. Herman, T., Giladi, N., Hausdorff, JM.[2022]

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]

Multidirectional treadmill training (MDTT) significantly improved gait and balance in individuals with Parkinson disease (PD) after just one session, with notable enhancements in stride length and turning ability.

Training for six weeks yielded the best long-term improvements in gait speed and balance, suggesting that this duration may be optimal for rehabilitation in PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute and Long-Term Effects of Multidirectional Treadmill Training on Gait and Balance in Parkinson Disease. Bryant, MS., Workman, CD., Hou, JG., et al.[2018]

Robotic treadmill training significantly improved functional mobility and walking capacity in patients with mild to moderate Parkinson's disease, as evidenced by better scores in the Timed Up and Go test, 10 meter walking test, and UPDRS motor subscale after 5 weeks of training.

While the training led to a temporary enhancement in quality of life, measured by the Parkinson's Disease Questionnaire-39, these improvements reverted to baseline levels by the 12-week follow-up, indicating that ongoing training may be necessary for sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of robotic treadmill training on functional mobility, walking capacity, motor symptoms and quality of life in ambulatory patients with Parkinson's disease: a preliminary prospective longitudinal study. Paker, N., Bugdayci, D., Goksenoglu, G., et al.[2022]

Patients with Parkinson's disease (PD) showed significant improvements in their walking patterns when using a treadmill, including increased step length and height, and reduced cadence and step width variability.

Treadmill walking helped PD patients reduce their characteristic short shuffling steps, suggesting that treadmill training could be beneficial for gait modifications in these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatiotemporal parameters of gait during treadmill and overground walking in Parkinson's disease. Bello, O., Sánchez, JA., Vazquez-Santos, C., et al.[2014]

Treadmill training has been shown to significantly improve gait speed and stride length in patients with Parkinson Disease, based on a systematic review of 18 trials, indicating its potential effectiveness in rehabilitation.

The training was found to be safe, with no increase in dropout rates or reported adverse events, suggesting that it is an acceptable therapy for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. Mehrholz, J., Kugler, J., Storch, A., et al.[2018]

In a pilot study involving 17 patients with mild to moderate Parkinson's disease, those who underwent 12 sessions of treadmill training showed significant improvements in cognitive and motor performance compared to a control group that did not train.

The treadmill training group demonstrated better scores on the Frontal Assessment Battery and improved performance on the 6-minute walking test, suggesting that this type of exercise could be beneficial for managing symptoms of Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of treadmill training on cognitive and motor features of patients with mild to moderate Parkinson's disease: a pilot, single-blind, randomized controlled trial. Picelli, A., Varalta, V., Melotti, C., et al.[2019]

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]

In a study of 82 participants with Parkinson disease, most walking occurred at low intensities, with an average of 157.3 minutes spent walking at the lowest intensity level (1-19 steps per minute), indicating a need for interventions to promote higher intensity walking.

Despite high daily step counts, participants engaged in few sustained walking bouts lasting 20 minutes or more, highlighting the importance of encouraging longer and more intense walking sessions for potential health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural Walking Intensity in Persons With Parkinson Disease. Girnis, JL., Cavanaugh, JT., Baker, TC., et al.[2023]

This study is a Phase 3 clinical trial involving 370 participants with Parkinson's disease, aiming to determine if high-intensity endurance exercise can slow disease progression compared to moderate-intensity exercise over 18 months.

The primary outcome will be measured using the MDS-UPDRS motor score, and if successful, this research could lead to a significant breakthrough in Parkinson's treatment, improving the quality of life for patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial. Patterson, CG., Joslin, E., Gil, AB., et al.[2023]

A 15-week multicomponent rehabilitation program that included water and land-based exercises significantly improved disease impact and quality of life in Parkinson's disease patients, as measured by the UPDRS and PDQ-39 scales.

Adding treadmill training to the water and land-based exercise program did not provide additional benefits for quality of life or disease impact, suggesting that the treadmill component may have limited effects in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training combined with water and land-based exercise programs: Effects on Parkinson's disease patients. Ayan, C., Varela, S., Vila, MH., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12384747/

Treadmill Training in Patients with Parkinson's Disease

In conclusion, our meta-analysis confirmed that treadmill training is an effective rehabilitation strategy for improving gait and mobility in PD ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4574905/

Randomized Clinical Trial of 3 Types of Physical Exercise ...

Both the higher- and lower-intensity treadmill exercises improved cardiovascular fitness. Only the stretching and resistance exercises improved muscle strength.

3.

michaeljfox.org

michaeljfox.org/news/high-intensity-treadmill-exercise-may-slow-parkinsons-progression

High-Intensity Treadmill Exercise May Slow Parkinson's ...

The results, published in JAMA Neurology, demonstrate that regular exercise on a treadmill at a high intensity may slow progression of PD.

4.

medicine.yale.edu

medicine.yale.edu/news-article/high-intensity-exercise-can-reverse-neurodegeneration-in-parkinsons-disease/

High-intensity Exercise May Reverse Neurodegeneration in ...

Six months of high-intensity aerobic exercise preserves the dopamine-producing neurons in the brain, a small pilot study finds.

5.

nature.com

nature.com/articles/s41531-022-00418-4

A systematic review and meta-analysis on effects of ...

Aerobic exercise had beneficial effects in improving balance, gait (velocity and stride/step length), and motor function in PD patients.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04284436

NCT04284436 | Study in Parkinson Disease of Exercise

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the MDS-UPDRS Part III score at 12 months.