Exercise for Parkinson's Disease

(HI-LITE Trial)

Overseen By Joe R Nocera, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Antiparkinsonian medications

Must not be taking: Antipsychotics, Beta-blockers

Disqualifiers: Major depression, Stroke, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 52 weeks

123 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best exercise routine for people with mid-stage Parkinson's disease (PD). It compares high-volume dance exercises, moderate-volume dance exercises, and moderate-volume walking to identify which method best improves movement, physical activity levels, and overall health. Participants with PD symptoms such as stiffness, slow movement, or tremors, who experience relief from their medications, might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve exercise recommendations for Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires participants to be observed while not taking their antiparkinsonian medications to avoid certain side effects and fluctuations. This means you will need to stop these medications during specific observation periods.

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

Research has shown that partnered dance aerobic exercise (PDAE) is generally well-tolerated by people with Parkinson's disease. Studies have found that PDAE can reduce "OFF-time" (when medication isn't working well) and improve quality of life. No major safety issues have been reported for PDAE, whether done in high or moderate amounts, suggesting it is a safe option for people with Parkinson's.

For moderate volume walking (MV-WALK), research indicates that moderate aerobic exercise, like walking, helps improve balance and walking ability. It is considered safe for people with Parkinson's, with no major reports of negative effects. Walking is often recommended for its overall health benefits and easy-to-manage intensity.

Both partnered dance and walking exercises are safe, with research supporting their use in improving symptoms and overall well-being in people with Parkinson's. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Parkinson's Disease because they explore innovative, non-pharmacological methods to improve movement and balance. Unlike standard treatments that often rely on medication to manage symptoms, these approaches use dance and walking as interactive, physical therapies. The High Volume Partnered Dance Aerobic Exercise (HV-PDAE) and the Moderate Volume Partnered Dance Aerobic Exercise (MV-PDAE) offer unique social and rhythmic elements, with dance adapted specifically for older adults with balance impairments. Participants engage in Argentine tango-inspired movements with partners, which can enhance coordination. Meanwhile, the Moderate Volume Walking (MV-WALK) arm provides a structured yet flexible walking routine aimed at improving gait. Collectively, these methods emphasize physical engagement and social interaction, which can provide holistic benefits beyond those offered by typical medical interventions.

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

This trial will compare different exercise interventions for Parkinson's disease. Studies have shown that partnered dance aerobic exercise (PDAE) reduces OFF-time in people with Parkinson's disease (PD). OFF-time refers to periods when symptoms are not well-controlled. In this trial, participants may receive either high-volume or moderate-volume PDAE. Research indicates that both high and moderate amounts of PDAE improve quality of life and movement abilities in people with PD. Evidence suggests that PDAE is more effective than simple walking programs for these improvements. However, another group in this trial will engage in moderate-volume walking, which also benefits participants by improving walking speed and gait. Regular moderate-intensity walking can help manage the disease and increase physical activity levels. Each exercise type in this trial has its own strengths in managing PD symptoms. ^{2 3 4 5 6}

Who Is on the Research Team?

Madeleine E. Hackney, PhD

Principal Investigator

Atlanta VA Medical and Rehab Center, Decatur, GA

Are You a Good Fit for This Trial?

This trial is for veterans over 40 with moderate Parkinson's disease (stages 2 to 3), who can walk at least 10 feet and have a certain level of cognitive function. They must not have severe depression, major psychiatric illness, significant hearing loss, or serious heart conditions. Participants should benefit from Parkinson's medication and be able to commit to the study duration without long absences.

Inclusion Criteria

I can walk at least 10 feet by myself or with help.

Your vision with glasses or contacts is better than 20/70 in your better eye.

My Parkinson's disease is at a moderate stage.

Exclusion Criteria

Your hearing sensitivity at certain frequencies is worse than 40 decibels.

I have not been treated for major depression or serious mental illness.

I have had a stroke or traumatic brain injury in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in Partnered Dance Aerobic Exercise (PDAE) or Walking for 52 weeks, with varying frequency and duration based on group assignment

52 weeks

HV-PDAE: 5 times a week for 90 minutes for 3 weeks initially, then every 4 weeks; MV-PDAE and MV-WALK: twice-weekly for 65 minutes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HV-PDAE: High Volume Partnered Dance Aerobic Exercise
• MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
• MV-WALK: Moderate Volume Walking

Trial Overview

The study compares two exercise regimens for those with mid-stage Parkinson's: one involves high volume dance aerobic exercise once a month followed by three weeks rest; the other is moderate exercise done consistently every week. The effects on walking speed, physical activity levels, blood biochemistry, and blood vessel stiffness will be measured.

How Is the Trial Designed?

Group I: HV-PDAE: High Volume Partnered Dance Aerobic Exercise Experimental Treatment 1 Intervention

HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 112.5h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.

Group II: MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise Active Control 1 Intervention

MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions. All participants will receive 112.5h of training. . PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.

Group III: MV-WALK: Moderate Volume Walking Active Control 1 Intervention

MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for exercise expends 3 METS, like PDAE. (Knaggs et al., 2011) 65 minute sessions will consist of 15 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down. Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors. This protocol is in line with recommendations for gait training to improve gait parameters, i.e., 2-3 days per week, for 30-60 minutes and with evidence that light-moderate intensity walking programs can lead to gains in gait parameters.

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

A 12-week study involving 11 participants with Parkinson's disease showed that both tango dance and a mixed styles dance intervention improved balance and endurance, but tango specifically improved mobility and motor signs.

The findings suggest that tango dance may be more effective than the Dance for Parkinson's model in enhancing certain motor functions in people with Parkinson's disease, highlighting the importance of comparing different exercise interventions for optimal treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Effects of Tango Versus Dance for PD in Parkinson Disease. McNeely, ME., Mai, MM., Duncan, RP., et al.[2020]

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]

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]

Aerobic walking is safe and well-tolerated for individuals with mild to moderate Parkinson's disease, leading to significant improvements in aerobic fitness, motor function, fatigue, mood, and quality of life, based on a study involving 60 participants over 2 years.

The study found that continuous aerobic training was more favorable than interval training due to fewer musculoskeletal adverse events, and improvements in maximum oxygen consumption were linked to better cognitive performance and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting. Uc, EY., Doerschug, KC., Magnotta, V., et al.[2022]

A 16-week aerobic exercise program for 8 Parkinson's Disease patients led to a significant 26% improvement in aerobic capacity, indicating that exercise can benefit PD patients similarly to healthy individuals.

The intervention also resulted in faster movement initiation times, suggesting that aerobic exercise may help counteract the slowing of muscle activation associated with Parkinson's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise intervention improves aerobic capacity and movement initiation in Parkinson's disease patients. Bergen, JL., Toole, T., Elliott, RG., et al.[2022]

The Dance for PD® (DfPD®) program significantly improved gait parameters such as velocity, cadence, and step length in people with Parkinson's disease, particularly when walking on even surfaces and during dual-task conditions like verbal fluency and serial subtraction.

These improvements suggest that dance-based interventions may enhance movement confidence, coordination, and cognitive skills in individuals with Parkinson's disease, indicating a need for larger-scale randomized controlled trials to further explore these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dance on gait and dual-task gait in Parkinson's disease. Haputhanthirige, NKH., Sullivan, K., Moyle, G., et al.[2023]

In a 6-month community-based cycling program for 41 participants with Parkinson's disease, significant improvements were observed in motor function, as indicated by a decrease in the MDS-UPDRS-III score, suggesting that aerobic exercise can help slow disease progression.

Participants who attended at least 74% of the cycling classes experienced the greatest benefits, highlighting the importance of consistent exercise attendance and maintaining a higher pedaling cadence for mitigating Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based high-intensity cycling improves disease symptoms in individuals with Parkinson's disease: A six-month pragmatic observational study. Rosenfeldt, AB., Miller Koop, M., Penko, AL., et al.[2023]

In a study involving 19 individuals with Parkinson's disease, those who participated in tango classes showed significant improvements in balance, as measured by the Berg Balance Scale, compared to those in traditional exercise classes.

Both tango and exercise classes led to overall improvements in Parkinson's disease symptoms, but only the tango group demonstrated a trend toward better mobility on the Timed Up and Go test, suggesting that tango may be a more effective intervention for enhancing functional mobility in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of tango on functional mobility in Parkinson's disease: a preliminary study. Hackney, ME., Kantorovich, S., Levin, R., 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]

Regular participation in vigorous-intensity exercise, such as Rock Steady Boxing, fosters important social connections for individuals with Parkinson's disease, enhancing their sense of hope and purpose.

Engaging in these exercises not only boosts confidence and determination but also encourages individuals to pursue even more vigorous activities, highlighting the need for collaboration between healthcare providers and community programs in rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The meaning of regular participation in vigorous-intensity exercise among men with Parkinson's disease. Borrero, L., Miller, SA., Hoffman, E.[2022]

A 6-week targeted dance intervention significantly improved walking speed, cadence, and stride length in 11 participants with Parkinson's disease, indicating enhanced motor motivation.

The intervention specifically reduced variability in single support time, suggesting it may effectively counteract bradykinesia, with no reported adverse events during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A walking dance to improve gait speed for people with Parkinson disease: a pilot study. Harrison, EC., Earhart, GM., Leventhal, D., et al.[2021]

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