High-Intensity Treadmill Exercise for Parkinson's Disease

(SPARX3 Trial)

Recruiting at 29 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: 0

Duration: 12 months

370 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.

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 data supports the effectiveness of the treatment High-Intensity Treadmill Exercise for Parkinson's Disease?

Research shows that treadmill training can improve walking speed, stride length, and overall quality of life for people with Parkinson's disease. Additionally, endurance exercise on a treadmill is known to enhance fitness, gait, and mobility, and may even slow disease progression. ^{1 2 3 4 5}

Is high-intensity treadmill exercise safe for people with Parkinson's disease?

Research shows that high-intensity treadmill exercise is generally safe for people with Parkinson's disease and does not worsen symptoms. ^{3 6 7 8 9}

How does high-intensity treadmill exercise differ from other treatments for Parkinson's disease?

High-intensity treadmill exercise is unique because it focuses on improving walking capacity and gait through structured, repetitive walking sessions, which may lead to positive changes in the brain's ability to adapt (neural plasticity). Unlike medications, this treatment directly targets physical symptoms like stride length and speed, and its benefits can persist even after the exercise sessions have ended. ^{1 2 3 10 11}

Research Team

Daniel M Corcos, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Treadmill training for the treatment of gait disturbances in people with Parkinson's disease: a mini-review. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Spatiotemporal parameters of gait during treadmill and overground walking in Parkinson's disease. [2014]

3. Denmark pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Study in Parkinson's disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial. [2023]

5. Italy 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. [2019]

6. Italy pubmed.ncbi.nlm.nih.gov

Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Treadmill training combined with water and land-based exercise programs: Effects on Parkinson's disease patients. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Physical Activity in De Novo Parkinson Disease: Daily Step Recommendation and Effects of Treadmill Exercise on Physical Activity. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Natural Walking Intensity in Persons With Parkinson Disease. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Acute and Long-Term Effects of Multidirectional Treadmill Training on Gait and Balance in Parkinson Disease. [2018]

11. Netherlands 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. [2022]