Title: A Multimodal Exercise Program With Gamification for Parkinson Disease (MEP+G)
NCT Number: NCT06538298
Acronym: (MEP+G)
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Parkinson Disease
Interventions: OTHER: Multimodal Exercise Program with Gamification
Sponsor: California State University, Northridge
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-15
Completion Date: 2026-06-27
Locations: Equilibrium Physical Therapy, Ventura, California, 93003, United States

Summary:
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.

Primary Outcome Measures: Fidelity of intervention, Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no"., 21 months|Intervention Adherence, Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no", 21 months|Feasibility of Outcomes, 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., 21 months|Assessment of Data Collection, Data collection: measured using a pre-populated form and marked as a "yes" or "no" by the PI., 21 months|Assessment of Safety, Adverse events (i.e., falls): measured by the daily exercise plan as indicated by a numeric number and type of adverse event, 21 months|Assessment of Participants Perception, 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, 21 months
Secondary Outcome Measures: Balance, Measured via using the Mini Balance Evaluation System Test (Mini-BESTest): a series of subtests with a total score from 0-28 points; with a higher score indicating improved balance., 21 months|Gait, Measured via Functional Gait Assessment (FGA): series of subtests based out of score from 0- 30 points; with a higher score indicating improved postural stability while walking., 21 months|Physical Activity, Measured via International Physical Activity Questionnaire (IPAQ) based on minutes exercise per week with a higher number of minutes indicating increased physical activity, 21 months|Gait Speed, Gait speed measured via 10 meters divided by number of seconds to determine gait speed of meters per second (m/s); a increased in m/s indicating improved gait speed., 21 months|Functional Strength, Functional strength measured by number of seconds required to perform 5 sit to stands (5TSTS) with a decrease in time indicating improved functional strength., 21 months|Cardiovascular Endurance, Cardiovascular endurance measured by total number of feet walked within a 6 minute timeframe (6MWT); an increase number of steps indicating improved cardiovascular endurance., 21 Months|Quality of life of Participants, Quality of life measured by Parkinson Disease Questionnaire: 39 (PDQ39) questions asking participants to rate various aspects of their condition using an ordinal scale: 0-4 (4)(Always, (3)Often, (2)Occasionally, (1)Sometimes, (0)Never; with a higher score indicating an increased quality of life, 21 months|Disease Severity, Disease severity measured by the Movement Disorder Society Unified Parkinson DiseaseRating (MDS UPDRS); 18 items measured using an ordinal scale (0-4).0=none;1=slight;2=minimal;3; moderate;4=severe; with a lower score indicating less severity, 21 months