Exercise Program for Parkinson's Disease

((MEP+G) Trial)

Overseen by Andrew S Bartlett, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: California State University, Northridge

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

In this pilot study the research will explore whether exercises and the outcome measures would be acceptable to conduct a more detailed research study. This 8 week pilot study will utilize a comprehensive exercise program that includes non-contact boxing along with computerized games for individuals with Parkinson Disease.

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 data supports the effectiveness of the treatment Multimodal Exercise Program with Gamification (MEP+G) for Parkinson's Disease?

Research suggests that exercise, including aerobic and gamified exercise, can help improve motor symptoms in Parkinson's disease. Studies have shown that home-based exergame training can enhance physical performance and cognitive function, which are often affected in Parkinson's patients. ^{1 2 3 4 5}

Is the exercise program with gamification safe for humans?

Research on exercise programs with gamification, like Dance Dance Revolution for Huntington's disease and aerobic exercise for Parkinson's disease, suggests they are generally safe for humans. These studies focus on the feasibility and safety of such programs, indicating they can be safely used under supervision. ^{1 2 3 6 7}

How is the Multimodal Exercise Program with Gamification (MEP+G) treatment different from other treatments for Parkinson's disease?

The Multimodal Exercise Program with Gamification (MEP+G) is unique because it combines physical exercise with gaming elements to make the therapy more engaging and motivating for patients with Parkinson's disease. This approach not only targets physical symptoms but also provides cognitive stimulation, which is not typically addressed in standard exercise programs. ^{1 2 5 8 9}

Research Team

Andrew S Bartlett, PhD

Principal Investigator

California State University, Northridge

Eligibility Criteria

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 stand by myself for 10 minutes.

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.

Trial Timeline

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

Treatment Details

Interventions

• Multimodal Exercise Program with Gamification (Behavioural Intervention)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. England 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. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Recent advances in rehabilitation for Parkinson's Disease with Exergames: A Systematic Review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based and remotely supervised aerobic exercise in Parkinson's disease: a double-blind, randomised controlled trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial. [2022]

5. England 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. [2019]

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

Video game play (Dance Dance Revolution) as a potential exercise therapy in Huntington's disease: a controlled clinical trial. [2022]

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

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

8. Italy pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Retraining function in people with Parkinson's disease using the Microsoft kinect: game design and pilot testing. [2022]