Exercise Training for Parkinson's Disease

Recruiting at1 trial location

Overseen by Amy Amara, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Neuroleptics

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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the effects of exercise rehabilitation on cognition and to evaluate slow wave sleep (SWS) as a biomarker and mediator of response to rehabilitation-induced improvement in cognitive performance among persons with Parkinson's disease (PwP), with the ultimate goal of maximizing rehabilitation efficacy at the individual level (i.e. precision rehabilitation).

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 data supports the effectiveness of the treatment Delayed Exercise Training (DE) and related exercise therapies for Parkinson's Disease?

Research shows that exercise and motor training are beneficial for people with Parkinson's disease, improving motor symptoms and movement efficiency. Goal-based task-specific training and endurance exercise have been particularly effective, suggesting that structured exercise programs can help manage Parkinson's symptoms. ^{1 2 3 4 5}

Is exercise training safe for people with Parkinson's disease?

The safety of exercise training for people with Parkinson's disease is not well-documented, as 72% of trials did not report adverse events, making it difficult to assess safety comprehensively. ^{2 6 7 8 9}

How does the exercise training treatment for Parkinson's disease differ from other treatments?

This exercise training treatment for Parkinson's disease is unique because it combines different types of physical activities like endurance and resistance training, which have been shown to improve motor symptoms and muscle strength. Unlike medications, this approach focuses on physical rehabilitation to enhance mobility and quality of life. ^{3 8 9 10 11}

Research Team

Amy Amara, MD, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

Findings from Research

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]

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]

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 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 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]

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]

References

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

Effects of Group, Individual, and Home Exercise in Persons With Parkinson Disease: A Randomized Clinical Trial. [2018]

2. United States 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. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

[New approaches in exercise therapy for Parkinson's disease]. [2022]

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

Endurance exercise training to improve economy of movement of people with Parkinson disease: three case reports. [2022]

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

Locomotor training in people with Parkinson disease. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Progressive Resistance Training Improves Bradykinesia, Motor Symptoms and Functional Performance in Patients with Parkinson's Disease. [2022]

7. Netherlands 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. [2022]

8. Switzerland 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. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Parkinson's disease and intensive exercise therapy--a systematic review and meta-analysis of randomized controlled trials. [2018]

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

A systematic review and meta-analysis of strength training in individuals with multiple sclerosis or Parkinson disease. [2022]