Exercise Program for Parkinson's Disease
((MEP+G) Trial)
Recruiting in Palo Alto (17 mi)
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?
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.12367
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.12589
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.
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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.
See 1 more
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 OverviewThe 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
2Treatment groups
Experimental Treatment
Active Control
Group I: Multimodal Exercise Program with GamificationExperimental Treatment1 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 ControlActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Equilibrium Physical TherapyVentura, CA
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Who Is Running the Clinical Trial?
California State University, NorthridgeLead Sponsor
References
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]Parkinson's disease (PD) is a neurodegenerative disorder with a wide range of motor and non-motor symptoms. Despite optimal medical management, PD still results in a high disability rate and secondary complications and many patients lead a sedentary lifestyle, which in turn is also associated with a higher co-morbidity and mortality. Exercise has been explored as a strategy to reduce secondary complications and results suggests that it not only provides general health benefits, but may also provide symptomatic relief. If this holds true exercise would be a very attractive addition to the therapeutic arsenal in PD. The supportive evidence remains incomplete. Here, we describe the design of the Park-in-Shape study, which primarily aims to evaluate whether aerobic exercise affords clinically relevant improvements in motor symptoms in sedentary PD patients. A specific new element is the introduction of gaming to optimize compliance to the exercise intervention.
Recent advances in rehabilitation for Parkinson's Disease with Exergames: A Systematic Review. [2023]The goal of this contribution is to gather and to critically analyze recent evidence regarding the potential of exergaming for Parkinson's disease (PD) rehabilitation and to provide an up-to-date analysis of the current state of studies on exergame-based therapy in PD patients.
Effectiveness of home-based and remotely supervised aerobic exercise in Parkinson's disease: a double-blind, randomised controlled trial. [2020]High-intensity aerobic exercise might attenuate the symptoms of Parkinson's disease, but high-quality evidence is scarce. Moreover, long-term adherence remains challenging. We aimed to evaluate the effectiveness of aerobic exercise-gamified and delivered at home, to promote adherence-on relieving motor symptoms in patients with Parkinson's disease with mild disease severity who were on common treatment regimes.
Home-based step training using videogame technology in people with Parkinson's disease: a single-blinded randomised controlled trial. [2022]To determine whether 12-week home-based exergame step training can improve stepping performance, gait and complementary physical and neuropsychological measures associated with falls in Parkinson's disease.
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]Complexity of an animal's environment has been shown to affect structural and functional changes in the brain. Evidence from animal models of Parkinson's disease (PD) suggests that exercising in an enriched environment may protect against the onset of Parkinsonian symptoms in rats that are exposed to 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine. The variety of activities and visual interfaces that can be created using commercially available gaming devices provide cognitively stimulating as well as physically challenging environments for exercise. This case series will: 1) elaborate on the rationale behind selection of specific games to target common deficits seen in PD; and 2) present preliminary results on clinical outcomes from three pilot participants who each completed six sessions of exercise. All three participants had mild to moderate PD. They were functionally independent individuals leading an active lifestyle. Participants were tested on the outcome measures before and after the six exercise sessions. On average, participants showed a 33.8% (22.8) improvement in functional reach test, 12.7% (35.0) improvement in single limb stance (SLS) time-right leg, 55.2% (33.9) improvement in SLS time-left leg, 11.9% (7.3) improvement in 6-min walk test, 2% (6.8) improvement in self-selected gait speed (GS), and 8.0% (5.8) improvement in fastest possible GS. Further investigation is warranted to study if these effects can be replicated over a longer exercise intervention and in a larger group, and if these effects are maintained at follow-up testing after the enriched exercise intervention is discontinued.
Video game play (Dance Dance Revolution) as a potential exercise therapy in Huntington's disease: a controlled clinical trial. [2022]To investigate the feasibility, acceptability, and safety of a supervised video game exercise program administered via Dance Dance Revolution in individuals with Huntington's disease.
Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. [2021]A burgeoning literature suggests that exercise has a therapeutic benefit in persons with Parkinson disease (PD) and in animal models of PD, especially when animals exercise at high intensity. If exercise is to be prescribed as "first-line" or "add-on" therapy in patients with PD, we must demonstrate its efficacy and dose-response effects through testing phases similar to those used in the testing of pharmacologic agents. The SPARX Trial is a multicenter, randomized, controlled, single-blinded, Phase II study that we designed to test the feasibility of using high-intensity exercise to modify symptoms of PD and to simultaneously test the nonfutility of achieving a prespecified change in patients' motor scores on the Unified Parkinson Disease Rating Scale (UPDRS). The trial began in May 2102 and is in the process of screening, enrolling, and randomly assigning 126 patients with early-stage PD to 1 of 3 groups: usual care (wait-listed controls), moderate-intensity exercise (4 days/week at 60%-65% maximal heart rate [HRmax]), or high-intensity exercise (4 days/week at 80%-85% HRmax). At 6-month follow-up, the trial is randomly reassigning usual care participants to a moderate-intensity or high-intensity exercise group for the remaining 6 months. The goals of the Phase II trial are to determine if participants can exercise at moderate and high intensities; to determine if either exercise yields benefits consistent with meaningful clinical change (nonfutility); and to document safety and attrition. The advantage of using a non-futility approach allows us to efficiently determine if moderate- or high-intensity exercise warrants further large-scale investigation in PD.
Samba, deep water, and poles: a framework for exercise prescription in Parkinson's disease. [2022]Parkinson's disease is a brain disorder that leads to tremor, slowness, muscle stiffness, and other movement disorders. The benefits of exercise for reducing disability in individuals with Parkinson's disease are numerous. However, not much is known about the designing and prescription of exercise in neurodegenerative diseases. A brief review and indications for exercise prescription and evaluation are discussed throughout. In this scoping review, we specifically aimed to describe the applicability of walking tests (6-min/10-m) for the prescription of exercise in individuals with Parkinson's disease and to propose training (undulating periodized) designs in three exercise modalities, Brazilian dance rhythms (Samba and Forró), deep-water exercises, and Nordic walking. These training models and evaluation methods may assist coaches and therapists in organizing exercise programs adequate to people with Parkinson's disease, and are essential steps toward a comprehensive and more detailed understanding of the training loads in motor disorders and disease states.
Retraining function in people with Parkinson's disease using the Microsoft kinect: game design and pilot testing. [2022]Computer based gaming systems, such as the Microsoft Kinect (Kinect), can facilitate complex task practice, enhance sensory feedback and action observation in novel, relevant and motivating modes of exercise which can be difficult to achieve with standard physiotherapy for people with Parkinson's disease (PD). However, there is a current need for safe, feasible and effective exercise games that are appropriate for PD rehabilitation. The aims of this study were to i) develop a computer game to rehabilitate dynamic postural control for people with PD using the Kinect; and ii) pilot test the game's safety and feasibility in a group of people with PD.