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

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The investigators propose a Stage-I randomized controlled trial (RCT) of a remotely-delivered, 16-week social-cognitive theory-based behavioral intervention focusing on combined exercise (aerobic and resistance) training for yielding increases in device-measured physical activity and improvements in cognitive function, symptoms, and quality of life (QOL), and social-cognitive theory (SCT) outcomes among physically inactive persons with Parkinson's disease (PD). Participants (N=50) will be randomly assigned into exercise training (combined aerobic and resistance exercise) condition or active control (flexibility and stretching) condition. The 16-week intervention will be delivered and monitored remotely within a participant\'s home/community and supported by Zoom-based chats guided by SCT via a behavioral coach. Participants will receive training materials (e.g., prescriptive manual and exercise equipment), one-on-one coaching, action-planning via calendars, self-monitoring via logs, and SCT-based newsletters. The investigators hypothesize that the home-based exercise intervention will yield improvements in cognitive, symptomatic, and QOL outcomes.

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.

Is the exercise program for Parkinson's disease safe for participants?

Exercise programs for Parkinson's disease, like the SPARX trial, have been studied for safety, with concerns mainly about the risk of falls and heart-related issues in more active patients. However, these programs are generally considered safe when properly supervised and tailored to individual needs. ^{1 2 3 4 5}

How is the GET Up PD treatment different from other treatments for Parkinson's disease?

The GET Up PD treatment is unique because it focuses on a structured exercise program specifically designed for Parkinson's disease, potentially incorporating elements like Tai Chi, resistance training, and personalized coaching, which are not typically part of standard medical treatments for this condition. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment GET Up PD for Parkinson's Disease?

Research shows that exercise programs, like Nordic walking, can improve mobility and quality of life for people with Parkinson's Disease. These benefits were observed immediately after training and persisted for months, suggesting that similar exercise treatments could be effective. ^{11 12 13 14 15}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. England 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. [2021]

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

The effects of balance training and high-intensity resistance training on persons with idiopathic Parkinson's disease. [2022]

3. Scotland pubmed.ncbi.nlm.nih.gov

Self-Reported Exercise Trends in Parkinson's Disease Patients. [2019]

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

Exercise for people in early- or mid-stage Parkinson disease: a 16-month randomized controlled trial. [2022]

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

Nordic walking improves mobility in Parkinson's disease. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The meaning of regular participation in vigorous-intensity exercise among men with Parkinson's disease. [2022]

7. England pubmed.ncbi.nlm.nih.gov

How might physical activity benefit patients with Parkinson disease? [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Implementation of a Community-Based Exercise Program for Parkinson Patients: Using Boxing as an Example. [2020]

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

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. [2021]

10. England pubmed.ncbi.nlm.nih.gov

A long-term community gym program for people with Parkinson's disease: a feasibility study of the Monash Health "Health and Fitness" model. [2023]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

The Efficacy of Exercise Programs for Parkinson's Disease: Tai Chi versus Combined Exercise. [2021]

12. Germany 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]. [2022]

13. United States 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. [2021]

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

Promoting Physical Activity via Telehealth in People With Parkinson Disease: The Path Forward After the COVID-19 Pandemic? [2020]

15. Italy pubmed.ncbi.nlm.nih.gov

Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. [2022]