Exercise Training for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Amy W Amara, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Neuroleptics

Disqualifiers: Cardiovascular disease, Pulmonary disease, Atypical Parkinsonism, others

Compensation: Varies

Number of Visits: 108

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of exercise can enhance cognitive function and sleep in people with Parkinson's disease. The study tests three exercise plans: delayed exercise training (a form of exercise rehabilitation), endurance training (aerobic exercise), and progressive resistance training (weightlifting). The goal is to determine if exercise can improve brain function and sleep quality, using slow wave sleep as a progress marker. People with Parkinson's disease who are not currently in an exercise program and have stable symptoms might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could improve the quality of life for those with Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires that you have been on stable medications for at least 4 weeks before joining and that you do not expect to change medications during the study.

What prior data suggests that exercise rehabilitation is safe for individuals with Parkinson's disease?

Research shows that Progressive Resistance Training (PRT) is generally safe for people with Parkinson's disease. Studies have found that PRT can improve muscle strength, movement, and quality of life without causing major side effects. Reports from various studies indicate that participants did not experience significant negative effects, making PRT a safe choice for those with Parkinson's.

Endurance Training (ET) is also considered safe for most people, including those with Parkinson's. It includes activities like walking or cycling, which are usually low-risk and beneficial for overall health. Most people handle endurance exercises well, with few reports of side effects.

Both types of exercise have been extensively studied, and research suggests they are safe and helpful for improving physical abilities in people with Parkinson's disease. Participants in these studies often report better strength and movement, with few negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise training for Parkinson’s disease because it explores how different types of exercise can improve symptoms in ways that standard medications might not. Progressive resistance training (PRT) is being studied for its potential to increase slow wave sleep, which is vital for recovery and brain health, possibly offering benefits beyond what medications like Levodopa or dopamine agonists provide. Endurance training (ET) and delayed exercise training (DE) are also being investigated for their ability to enhance physical and motor function, targeting the disease from a non-pharmaceutical angle. This approach could lead to more holistic management of Parkinson's, focusing on overall lifestyle and wellness.

What evidence suggests that these exercise treatments could be effective for Parkinson's disease?

Research has shown that progressive resistance training (PRT), which participants in this trial may receive, can greatly benefit people with Parkinson's disease. Studies have found that performing PRT 2-3 times a week significantly increases muscle strength and improves walking and balance. People with mild to moderate Parkinson's have reported a better quality of life and reduced freezing of gait after engaging in PRT. Additionally, aerobic exercises, included in the endurance training (ET) arm of this trial, have helped alleviate motor symptoms in Parkinson's patients. These exercises can play a crucial role in enhancing overall movement and well-being for those with the condition. ^{2 6 7 8 9}

Who Is on the Research Team?

Amy Amara, MD, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for people aged 45 or older with Parkinson's Disease (PD) who can walk without help and have mild to moderate symptoms. They should be on stable PD meds, not expecting changes during the study, and score between 18-26 on a cognitive test. Those with serious heart conditions, other types of Parkinsonism, deep brain stimulation implants, untreated sleep disorders or those already doing regular exercise cannot join.

Inclusion Criteria

My medications have been the same for the last 4 weeks and won't change during the study.

My cognitive test score is between 18 and 25.

My Parkinson's disease is at a moderate stage.

Exclusion Criteria

I show signs of unusual Parkinson-like symptoms.

You have had deep brain stimulation (DBS) treatment.

My Parkinson's symptoms were caused by medication, strokes, or head injuries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants undergo 12 weeks of supervised progressive resistance training (PRT) 3 times per week

12 weeks

36 visits (in-person)

Follow-up Treatment

Responders to PRT continue with PRT for an additional 12 weeks, while non-responders transition to endurance training (ET)

12 weeks

36 visits (in-person)

Delayed Exercise

Participants in the delayed exercise group do not exercise for the first 12 weeks, then transition to PRT for the second 12 weeks

24 weeks

36 visits (in-person) during the second 12 weeks

Follow-up

Participants are monitored for changes in cognition and slow wave sleep (SWS) after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delayed Exercise Training (DE)
• Endurance Training (ET)
• Progressive Resistance Training (PRT)

Trial Overview

The study tests how different exercise programs—Endurance Training (ET), Delayed Exercise Training (DE), Progressive Resistance Training (PRT)—affect thinking skills in PD patients and if Slow Wave Sleep can indicate improvement from these exercises.

How Is the Trial Designed?

Group I: Exercise Group Active Control 2 Interventions

PD participants randomized to progressive resistance training PRT) will have 12 weeks of supervised PRT 3 times per week. After the 1st 12 weeks, responders to PRT (increase in slow wave sleep) will continue PRT for an additional 12 weeks, non-responders to PRT will transition to endurance training (ET).

Group II: Delayed Exercise Group Placebo Group 2 Interventions

PD participants randomized to the delayed exercise control group will not exercise for the 1st 12 weeks of the study. After the 1st 12 weeks, participants in the delayed exercise group will transition to PRT for the 2nd 12 weeks.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A 9-week progressive resistance training program significantly reduced bradykinesia and improved functional performance in 40 individuals with mild to moderate Parkinson's Disease, as evidenced by improvements in various functional tests.

The training group showed marked enhancements in mobility and strength compared to a control group that did not participate in the training, highlighting the potential of resistance training as a beneficial therapy for managing Parkinson's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. Vieira de Moraes Filho, A., Chaves, SN., Martins, WR., et al.[2022]

A review of 53 randomized controlled trials on exercise and motor training for Parkinson's disease showed that most interventions were effective and well-supervised, lasting an average of 8.3 weeks, with high participant retention rates (69% retained ≥85% of participants).

However, the lack of detailed reporting on adherence and adverse events in 72% of trials may hinder clinicians' ability to implement these programs effectively in practice, as they need to weigh the benefits against potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and motor training in people with Parkinson's disease: a systematic review of participant characteristics, intervention delivery, retention rates, adherence, and adverse events in clinical trials. Allen, NE., Sherrington, C., Suriyarachchi, GD., et al.[2021]

Resistance training (RT) significantly improves muscle strength, motor impairment, mobility, balance, and quality of life in patients with Parkinson's disease, based on a meta-analysis of 18 randomized controlled trials.

While RT shows large effects compared to passive control groups, it does not demonstrate superior benefits over other physically active interventions, suggesting that any form of exercise is beneficial for Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Resistance Training on Motor- and Non-Motor Symptoms in Patients with Parkinson's Disease: A Systematic Review and Meta-Analysis. Gollan, R., Ernst, M., Lieker, E., et al.[2022]

A network meta-analysis of 20 trials involving 719 patients with Parkinson's disease found that short periods of high-intensity resistance training significantly improved motor symptoms, as measured by the Unified Parkinson's Disease Motor Rating Scale (UPDRS III).

Both aerobic and resistance training at varying intensities showed efficacy in improving motor symptoms and quality of life in Parkinson's patients, suggesting that exercise prescriptions should include these modalities, although further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of aerobic and resistance training on the motor symptoms in Parkinson's disease: Systematic review and network meta-analysis. Zhou, X., Zhao, P., Guo, X., et al.[2023]

Progressive resistance training (PRT) significantly improves freezing of gait, muscular strength, and quality of life in patients with Parkinson's disease, based on a systematic review of 14 studies involving 761 participants.

While PRT showed positive effects, it did not significantly improve gait velocity, stride length, or balance as measured by the Berg Balance Scale, indicating that its benefits may be more focused on specific aspects of mobility and strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Progressive Resistance Training in Parkinson's Disease: A Systematic Review and Meta-Analysis. Yang, X., Wang, Z.[2023]

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]

Task-specific training with perturbations has been shown to effectively improve gait and balance in people with Parkinson's disease, potentially reducing the risk of falls, based on initial randomized controlled trials.

Combining task-specific training with cardiovascular exercise may enhance neuroplasticity, leading to better therapy outcomes, although the current quality of evidence for these approaches is still low and more rigorous studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New approaches in exercise therapy for Parkinson's disease]. Wanner, P., Klamroth, S., Steib, S.[2022]

A 4-month supervised endurance exercise program improved walking economy in all three patients with early to middle-stage Parkinson's disease, and these improvements were maintained for 16 months.

Two of the patients also showed significant improvements in other measures of physical function and motor symptoms, indicating that structured exercise can have lasting benefits for individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. Schenkman, M., Hall, D., Kumar, R., et al.[2022]

Physical therapists play a crucial role in locomotor training for individuals with Parkinson's disease, adapting their approach based on factors like disease progression, medication, and individual goals.

The article emphasizes the importance of tailoring gait training to address specific impairments and activity limitations at various stages of Parkinson's disease, using principles of neural adaptation to enhance therapy effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor training in people with Parkinson disease. Morris, ME.[2022]

Resistance Training (RT) is shown to significantly improve muscle strength in individuals with Parkinson's Disease, with a moderate effect size based on a meta-analysis of 15 randomized controlled trials.

All three exercise modalities—Resistance Training, Endurance Training, and Other Intensive Training Modalities—are safe and feasible, potentially benefiting balance, walking performance, and quality of life in Parkinson's Disease, with no reported deterioration in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy--a systematic review and meta-analysis of randomized controlled trials. Uhrbrand, A., Stenager, E., Pedersen, MS., et al.[2018]

Strength training significantly improves muscle strength in individuals with Parkinson disease (15%-83.2% increase) and to a lesser extent in those with multiple sclerosis (4.5%-36% increase), based on a systematic review of 20 studies.

In addition to muscle strength, strength training also enhances mobility and may slow disease progression in Parkinson disease, while improving fatigue, functional capacity, quality of life, and muscle activity in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of strength training in individuals with multiple sclerosis or Parkinson disease. Cruickshank, TM., Reyes, AR., Ziman, MR.[2022]

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