NCT06538298 · California State University, Northridge
Title: A Multimodal Exercise Program With Gamification for Parkinson Disease (MEP+G)
((MEP+G))
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Multimodal Exercise Program with Gamification
A comprehensive exercise program for 3 days a week for 6 weeks that utilizes non-contact boxing and gamification at moderate to vigorous intensity.
Primary outcome measures
Fidelity of intervention
Time frame: 21 months
Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no".
Intervention Adherence
Time frame: 21 months
Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no"
Feasibility of Outcomes
Time frame: 21 months
Retention: number of participants who completed the entire program divided by total number who started; x 100 to determine the percentage of participants who completed the program.
Assessment of Data Collection
Time frame: 21 months
Data collection: measured using a pre-populated form and marked as a "yes" or "no" by the PI.
Assessment of Safety
Time frame: 21 months
Adverse events (i.e., falls): measured by the daily exercise plan as indicated by a numeric number and type of adverse event
Assessment of Participants Perception
Time frame: 21 months
Measured via Qualtrics survey asking participants "How satisfied were you in participating in this study" using an ordinal scale (0-4): (4)(strongly agree; (3)agree; (2)neutral; (1)disagree; (0)strongly disagree); with a higher score reflection increased satisfaction
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Hoehn and Yahr stages 1-3 disease as determined by primary care physician, neurologist, or movement disorder specialist
- diagnosis of idiopathic Parkinson's Disease
- ability to ambulate with or without an assistive device
- transportation to and from testing site
- ability to stand unassisted for 10 minutes
- stable on Parkinson's disease medications for 3 months as determined by physician
- medical clearance by their PCP, neurologist, or movement disorder specialist to participate in a moderate to vigorous exercise program.
Exclusion criteria
- other neurological disease other than Parkinson's disease
- having had deep brain stimulation within the past 3 months , as determined by their physician
- currently participating in a Rock Steady boxing program
- self-report participation in moderate to vigorous exercise greater than 60 minutes per week.
Where
- Ventura, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2024 · Source of record for eligibility and locations