Exercise Program for Parkinson's Disease

((MEP+G) Trial)

Overseen By Andrew S Bartlett, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: California State University, Northridge

Disqualifiers: Other neurological disease, recent deep brain stimulation, others

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

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special exercise program for people with Parkinson's Disease to determine its potential for further study. The program, called the Multimodal Exercise Program with Gamification, includes boxing drills and engaging computerized games to improve balance, strength, and cognitive skills. Participants will exercise for 6 weeks, 3 times a week, with each session lasting an hour. Individuals with Parkinson's Disease who can walk and have been stable on their medications for the last 3 months might be suitable candidates. As an Early Phase 1 trial, this study aims to understand how the exercise program affects participants, offering them a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that participants have been stable on their Parkinson's disease medications for 3 months, so you will not need to stop taking your current medications.

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

Research has shown that exercise programs, like the one under testing, are generally safe and well-tolerated for people with Parkinson’s disease. One study found that a similar exercise program improved strength and mobility, suggesting these exercises can be beneficial without causing harm.

The current trial is in the early stages, focusing mainly on assessing safety and practicality. Researchers will closely monitor participants for any possible side effects. Although specific safety data from this trial is not yet available, combining exercise with game-like activities has shown promise in being safe and enjoyable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment for Parkinson's disease because it combines physical exercise with gamification, offering a fresh approach to therapy. Unlike traditional treatments that focus on medication or standard physical therapy, this multimodal exercise program incorporates strengthening, balance, aerobic, and flexibility exercises with a computerized game to boost cognitive engagement. The inclusion of non-contact boxing and the interactive SMARTfit game adds a fun, competitive element that can enhance motivation and adherence to the program. This innovative approach aims to improve not only physical capabilities but also mental agility, which could lead to better overall outcomes for those with Parkinson's.

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

Research has shown that exercise can improve movement problems in people with Parkinson's disease. In this trial, participants may join a Multimodal Exercise Program with Gamification, which includes aerobic and game-like exercises. These programs can increase walking speed and overall movement. The exercise program features non-contact boxing and computer games, designed to enhance strength, balance, and cognitive skills. Although more detailed research is needed, early results are promising for alleviating Parkinson's symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrew S Bartlett, PhD

Principal Investigator

California State University, Northridge

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are interested in participating in an 8-week exercise program that includes non-contact boxing and computerized games. The study aims to determine if these activities and outcome measures are acceptable for a more detailed future study.

Inclusion Criteria

I have been diagnosed with Parkinson's Disease.

I can walk by myself or with help from a device.

I can get to and from the testing site on my own.

Exclusion Criteria

Currently participating in a Rock Steady boxing program

Self-report participation in moderate to vigorous exercise greater than 60 minutes per week.

I have a neurological condition that is not Parkinson's disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a multimodal exercise program with gamification, including non-contact boxing and computerized games, for 6 weeks, 3 days per week.

6 weeks

18 sessions (in-person)

Make-up Week

Participants have the option to attend a make-up week if any exercise sessions were missed during the treatment phase.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post-testing and surveys.

4 weeks

1 visit (in-person), online survey

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Exercise Program with Gamification

Trial Overview The intervention being tested is a multimodal exercise program combined with gamification elements, specifically designed for people with Parkinson's Disease. This pilot study will assess the feasibility of the exercises and their potential benefits over an 8-week period.

How Is the Trial Designed?

Group I: Multimodal Exercise Program with Gamification Experimental Treatment 1 Intervention

The exercise program will be for 6 weeks, 3 days per week for 60 minutes per session and will consist of strengthening, balance, aerobic, flexibility, and use a computerized game to challenge thinking and reactions skills. The exercise program will also consist of non-contact boxing to improve strength, balance, and aerobic endurance. Each exercise session will be conducted by a licensed physical therapist. The format will consist of a 10-15-minute warm-up followed by 30 minutes of moderate to vigorous circuit training using boxing drills and a computerized game called SMARTfit. SMARTfit consists of a standing computer board that allows participants to touch, punch or kick it while playing a game. At the end of the 30 minutes, participants will complete a 10-15-minute cool-down consisting of core strengthening, posture training, and hip strengthening and stretching exercises. Participants will also be instructed to maintain their normal activities outside of the study intervention.

Group II: Wait List Control Active Control 1 Intervention

Participants randomly assigned to the wait list control group, will perform baseline testing and be instructed not to change their exercise habits. After 6 weeks participants will complete post-testing (described below) and be offered to be enrolled in the 6-week exercise group as described above. If participants decide to participate in the exercise group and still meet the inclusion and exclusion criteria, they will perform baseline testing, 6 weeks of exercise followed by another post-testing.

Who Is Running the Clinical Trial?

California State University, Northridge

Lead Sponsor

Trials

13

Recruited

2,700+

Published Research Related to This Trial

A new computer game designed for rehabilitation using the Microsoft Kinect was developed to improve dynamic postural control in people with Parkinson's disease, and it was found to be safe and enjoyable for participants during a pilot test with nine individuals.

Participants reported feeling safe while using the game, with no adverse events, and most expressed interest in using it at home to enhance their balance, although some faced challenges with certain visual tasks and coordination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retraining function in people with Parkinson's disease using the Microsoft kinect: game design and pilot testing. Galna, B., Jackson, D., Schofield, G., et al.[2022]

A 12-week home-based exergame step training program did not show significant improvements in stepping performance or gait for people with Parkinson's disease compared to a control group, except for a notable decline in mobility for the control group.

Participants with lower disease severity reported improvements in mobility and physical function, suggesting that while the training may not be broadly effective, it could benefit certain individuals with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial. Song, J., Paul, SS., Caetano, MJD., et al.[2022]

Engaging in exercise within a cognitively stimulating environment, such as using gaming devices, showed promising improvements in physical function for three participants with mild to moderate Parkinson's disease, with an average improvement of 33.8% in functional reach and significant gains in balance and walking tests.

These preliminary results suggest that enriched exercise environments may help mitigate some symptoms of Parkinson's disease, but further research is needed to confirm these findings in larger groups and over longer periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of commercially available games for a combined physical and cognitive challenge during exercise for individuals with Parkinson's disease - a case series report. Pradhan, S.[2019]

Exergaming, using platforms like Microsoft Kinect and Wii Balance Board, has been shown to improve motor skills in Parkinson's disease patients and is considered safe and feasible for rehabilitation, even in home settings.

Clinical trials indicate that exergame-based therapy is at least as effective as traditional rehabilitation methods, with improvements in both motor and cognitive functions, highlighting its potential as a valuable treatment option for PD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in rehabilitation for Parkinson's Disease with Exergames: A Systematic Review. Garcia-Agundez, A., Folkerts, AK., Konrad, R., et al.[2023]

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]

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]

The Park-in-Shape study will evaluate the effects of aerobic exercise combined with gaming elements (exergaming) on motor symptoms in 130 sedentary patients with mild to moderate Parkinson's disease over 6 months, aiming to provide symptomatic relief.

This randomized controlled trial uses a double-blind design and focuses on the MDS-UPDRS motor score as the primary outcome, highlighting the potential of exercise as a therapeutic strategy in managing Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of the Park-in-Shape study: a phase II double blind randomized controlled trial evaluating the effects of exercise on motor and non-motor symptoms in Parkinson's disease. van der Kolk, NM., Overeem, S., de Vries, NM., et al.[2018]

A 6-month study involving 130 patients with mild Parkinson's disease showed that home-based aerobic exercise significantly improved motor symptoms, with a clinically relevant difference of 4.2 points on the MDS-UPDRS scale compared to a stretching control group.

The aerobic exercise program, enhanced with gamified elements and remote supervision, was well-tolerated, with a low incidence of adverse events, suggesting it is a safe and effective intervention for managing symptoms in Parkinson's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based and remotely supervised aerobic exercise in Parkinson's disease: a double-blind, randomised controlled trial. van der Kolk, NM., de Vries, NM., Kessels, RPC., et al.[2020]

The Dance Dance Revolution exercise program was found to be feasible and safe for 18 individuals with Huntington's disease, with participants enjoying the game and wanting to continue after the study.

Participants showed significant improvements in gait stability, particularly in reducing double support time during walking, indicating potential benefits for mobility in individuals with Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video game play (Dance Dance Revolution) as a potential exercise therapy in Huntington's disease: a controlled clinical trial. Kloos, AD., Fritz, NE., Kostyk, SK., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06538298

Title: A Multimodal Exercise Program With Gamification for ... In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study.

2. withpower.com withpower.com/trial/early-phase-1-parkinson-disease-8-2024-5212f

Exercise Program for Parkinson's Disease ((MEP+G) Trial) Research suggests that exercise, including aerobic and gamified exercise, can help improve motor symptoms in Parkinson's disease. Studies have shown that home- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12396673/

Gamification-based tele-rehabilitation for physical therapy ... GBT has the potential to offer a safe, engaging and effective physical therapy to the PD population in home settings, but further research is ...

4. publish.kne-publishing.com publish.kne-publishing.com/index.php/EHJ/article/download/17366/16167

The Effects of Multimodal Exercise Program on Functional ... However, MEP have been shown to improve walking speed in Parkinson's patients (35). The results of the present study showed that after 12 weeks ...

5. clinconnect.io clinconnect.io/trials/NCT06538298

Title: A Multimodal Exercise Program With Gamification In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study.

6. researchgate.net researchgate.net/publication/362433435_Multimodal_exercise_program_contributes_to_balance_and_motor_functions_in_men_and_women_with_Parkinson's_disease_differently_an_intervention_study

(PDF) Multimodal exercise program contributes to balance ... Results: Overall, there was an improvement in the strength of the lower limbs (LL) (p = 0.035) and upper limbs (UL) (p = 0.009), functional mobility (p = 0.003) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10114534/

Multi-Modal Rehabilitation Therapy in Parkinson's Disease ... A recent study found that a low-intensity 8 week cycling intervention (total of 16 training sessions) resulted in significant improvement of UPDRS-III [P-value ...