Exercise Program for Parkinson's Disease

(LifePD Trial)

Overseen By Brenda Jeng, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Severe cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a home-based exercise program for people with Parkinson's disease. It compares the effects of a combined aerobic and resistance exercise routine to a stretching and flexibility routine. The goal is to determine if the exercise program, called GET Up PD, can improve physical activity, cognitive function, symptoms, and quality of life. The trial seeks participants who have Parkinson's, are not very active, and can walk without assistance. Participants will receive exercise equipment, coaching, and support through online chats. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance daily living for those with Parkinson's.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your doctor for guidance.

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

This trial focuses on an exercise program called GET Up PD, designed for people with Parkinson's disease. Research has shown that exercise programs like GET Up PD are generally safe. Exercise, a non-drug treatment, is well-tolerated by many, including those with Parkinson's.

The program includes aerobic exercises (such as walking or cycling) and resistance training (like weight lifting). These exercises are often recommended for overall health and have been shown to improve symptoms in people with Parkinson's without causing significant side effects. No serious problems have been reported with these types of exercise programs for Parkinson's. However, as with any physical activity, a small risk of injury exists, but this risk remains low when exercises are performed correctly and with guidance.

Based on evidence from similar exercise treatments, GET Up PD should be safe for participants. It is important to consult a healthcare provider to ensure any new exercise program is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GET Up PD program because it offers a fresh approach to managing Parkinson's disease through a remotely-coached, home-based exercise regimen. Unlike traditional treatments that often focus on medication, GET Up PD emphasizes aerobic fitness and muscle strength, using telerehabilitation to guide patients in their own homes. This method not only enhances accessibility for people living with Parkinson's but also encourages consistent physical activity, which is crucial for managing symptoms. Additionally, the use of telerehabilitation makes it easier for patients to receive personalized coaching without having to travel, which is a significant advantage over conventional exercise programs that require in-person visits.

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

This trial will compare two exercise programs for people with Parkinson's disease. Participants in one arm will engage in the GET Up PD program, a remotely-coached, home-based program focusing on aerobic fitness and muscle strength. Research has shown that exercise programs like GET Up PD can help people with Parkinson's disease by boosting physical activity and improving thinking skills. Such exercise routines are linked to a better quality of life and fewer symptoms. Evidence suggests these benefits result from increased fitness and muscle strength, which are important for managing Parkinson's symptoms. Overall, regular exercise might offer a way to help manage the condition without medication. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert Motl, Ph.D

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for physically inactive individuals with Parkinson's Disease who are interested in improving their physical activity, cognitive function, symptoms, and quality of life. Participants will engage in a 16-week program from home using Zoom and must be willing to follow the exercise or stretching routines provided.

Inclusion Criteria

English as a primary language

Confirmed diagnosis of PD

Internet and email access

Exclusion Criteria

Severe cognitive impairment based on a modified Telephone Interview for Cognitive Status (TICS-M) score of less than 18

Above inclusion criteria not met

Moderate or high risk of contraindications for possible injury or death when undertaking strenuous or maximal exercise using the PAR-Q

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 16-week remotely-delivered, social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training or active control (flexibility and stretching) condition.

16 weeks

Remote sessions via Zoom

Follow-up

Participants are monitored for changes in cognitive function, symptoms, and quality of life after the intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GET Up PD

Trial Overview The study tests a social-cognitive theory-based behavioral intervention that includes aerobic and resistance exercises (GET Up PD) against an active control group doing flexibility and stretching. It aims to see if the exercise training can improve physical activity levels, cognitive functions, symptoms, and quality of life over 16 weeks.

How Is the Trial Designed?

Group I: GET Up PD Experimental Treatment 1 Intervention

Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on aerobic fitness and muscle strength as a mode of training

Group II: Stretching and Flexibility Active Control 1 Intervention

Remotely-coached/guided, home-based program delivered using telerehabilitation focusing on stretching and range of motion as the mode of training

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Both Tai Chi and combined stretching-strengthening exercises improved functional fitness in patients with mild-to-moderate Parkinson's disease after 8 weeks of training, compared to a control group that showed deterioration.

Tai Chi specifically enhanced the emotional quality of life for participants, while the combined stretching-strengthening exercise improved social quality of life, indicating that Tai Chi may be a particularly beneficial exercise strategy for improving overall well-being in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Exercise Programs for Parkinson's Disease: Tai Chi versus Combined Exercise. Cheon, SM., Chae, BK., Sung, HR., et al.[2021]

A tablet-based training program for Parkinson's disease patients was successfully tested over 9 months, helping them stay motivated and develop personalized training routines after inpatient treatment.

Patients reported positive aspects such as structured support and Parkinson's specificity, but also suggested improvements for better individualization and flexibility in training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation of an individualized tablet-based training program in the domestic setting following complex treatment of Parkinson's disease-Success factors and barriers]. Wagner, L., Deck, R.[2022]

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]

In a 16-month study involving 121 individuals with Parkinson's disease, the flexibility/balance/function exercise (FBF) program showed significant improvements in overall physical function compared to a home-based control group at 4 months.

The supervised aerobic exercise (AE) program demonstrated better walking economy than the FBF program at multiple time points (4, 10, and 16 months), indicating its effectiveness in enhancing physical performance in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. Schenkman, M., Hall, DA., Barón, AE., et al.[2022]

A 6-week Nordic walking program significantly improved mobility and quality of life in 19 patients with Parkinson's disease, with benefits observed immediately after training and maintained 5 months later.

The study reported excellent compliance and no adverse effects, suggesting that Nordic walking is a safe and effective exercise option for enhancing physical activity in individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nordic walking improves mobility in Parkinson's disease. van Eijkeren, FJ., Reijmers, RS., Kleinveld, MJ., et al.[2022]

Physical activity and exercise may provide significant benefits for patients with Parkinson's disease (PD), potentially improving overall health and even modifying the disease, as suggested by animal studies.

Clinical trials are necessary to confirm these benefits and to ensure safety, particularly regarding the risks of falls and cardiovascular issues, while also focusing on creating tailored exercise programs that can help overcome barriers like depression and postural instability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How might physical activity benefit patients with Parkinson disease? Speelman, AD., van de Warrenburg, BP., van Nimwegen, M., et al.[2022]

An 8-week resistance training program significantly improved maximum leg press strength relative to body mass in 18 individuals with Parkinson's disease, indicating enhanced lower-body strength (P < .05).

The training involved moderate volume, high-load exercises performed twice weekly, demonstrating that this type of resistance training can be beneficial for strength and function in people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of moderate-volume, high-load lower-body resistance training on strength and function in persons with Parkinson's disease: a pilot study. Schilling, BK., Pfeiffer, RF., Ledoux, MS., et al.[2021]

A Parkinson's disease-specific boxing program was well-received by participants, with 81% of patients and 80% of instructors expressing high satisfaction after an initial workshop, indicating strong acceptability of the program.

After 18 months, the program successfully expanded from 10 to 40 participants, with only mild adverse effects reported, suggesting that the program is safe and beneficial for individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. Domingos, J., Radder, D., Riggare, S., et al.[2020]

The SPARX Trial is a Phase II study involving 126 early-stage Parkinson's disease patients, designed to assess the feasibility and efficacy of high-intensity exercise as a treatment for PD symptoms, comparing it to moderate-intensity exercise and usual care.

The trial aims to determine if either exercise intensity can lead to meaningful clinical improvements in motor scores, while also ensuring participant safety and monitoring dropout rates, which will inform future large-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Moore, CG., Schenkman, M., Kohrt, WM., et al.[2021]

Exercise has numerous benefits for individuals with Parkinson's disease, helping to reduce disability and improve movement disorders.

This scoping review proposes specific exercise modalities, including Brazilian dance, deep-water exercises, and Nordic walking, along with walking tests to help therapists design effective exercise programs tailored for people with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. Peyré-Tartaruga, LA., Martinez, FG., Zanardi, APJ., et al.[2022]

A 6-month community exercise program for people with Parkinson's disease was found to be safe, with high adherence rates (37 out of 53 participants) and no serious adverse events related to the exercise.

The exercise group showed positive effects on motor symptoms, with a small effect size for improvements in walking distance and overall motor function, suggesting potential long-term benefits of regular exercise for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II randomised controlled trial of a 6-month self-managed community exercise programme for people with Parkinson's disease. Collett, J., Franssen, M., Meaney, A., et al.[2021]

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]

Citations

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Outcome Measures for Disease-Modifying Trials in ... This approach aimed to guide the maximal number of outcome measures/visit to be included in a disease-modifying PD trial. All outcome ...

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Key Findings Researchers used Parkinson's Outcomes Project data to better define demographic and treatment patterns in the young-onset Parkinson disease (YOPD) population.

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Lasting relief of Parkinson's motor symptoms found with DBS This dropped to 21.1 after one year, showing a 51% improvement. At five years, the score was 27.6, still reflecting a 36% improvement compared ...

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Outcome Assessment in Parkinson Disease Prevention Trials Using claims data, they identified 3,862 individuals who developed PD over a median of 3.5 years of follow-up. Participants with slow TUG ...

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Safety of AADC Gene Therapy for Moderately Advanced ... This study provides Class IV evidence that, in patients with moderately advanced PD and motor fluctuations, putaminal infusion of VY-AADC01 is well tolerated ...

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PD-DETECTOR: A sustainable and computationally ... This paper introduces a mobile cloud-based predictive model for assisting Parkinson's disease (PD) patients.

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The efficacy and safety of MARS-PD: Meridian activation ... The primary endpoint is the change in MDS-UPDRS Part III score from baseline to the conclusion of the 8-week intervention. Secondary outcomes encompass various ...

9. nature.com nature.com/articles/s41531-024-00772-5

Sensing data and methodology from the Adaptive DBS ... Here we summarize sensing data and aDBS programming steps associated with the ongoing Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease ( ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05635409

Study Details | NCT05635409 | A Trial to Determine the ... In this trial, the investigators will transplant a new stem cell therapy, called the STEM-PD product, into the area of the brain affected in people with PD.