Clinical trial NCT06538298: Title: A Multimodal Exercise Program With Gamification for Parkinson Disease (MEP+G)
Official title: A Multimodal Exercise Program With Gamification (MEP+G) in Individuals With Parkinson Disease: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Keywords: Multimodal Exercise
Gamification
Parkinson's Disease
Lead sponsor: California State University, Northridge
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized Controlled Pilot Study
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participates in the 6-week exercise group will be asked to perform the following three times per week for 6 weeks, with each session lasting 60 minutes: A multimodal group exercise program with approximately 3-5 other individuals with Parkinson's disease. The exercise program will consist of strengthening, balance, aerobic, flexibility, and the use of a computerized game to challenge participant's thinking and reactions skills. The exercise program will also consist of non-contact boxing (hitting punching bags) to improve strength, balance, and aerobic endurance. Each exercise session will be conducted by a licensed physical therapist who is trained in exercise programs using non-contact boxing (Certified Rock Steady Boxing Coach). Each exercise session will have the same format and exercises with only a slight variation. For example, all Monday classes will have a focus on strengthening, Wednesday classes will have a focus on balance and Friday classes will have a focus on power.

The format will consist of a 10-15-minute warm-up of stretching and exercises to gradually warm-up participant's muscles and increase heart rate. Following the warm-up, participates will complete 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 i.e., hitting all the buttons that display a smiley face.

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.

In the event participants missed any of the exercise sessions, a one-week "make up week" will be provided immediately following the 6-week intervention that participants can choose to attend.

Exercise Intensity will be monitored using a heart rate chest monitor (Myzone™). The Myzone™) heart rate monitor will allow the instructor/researcher to monitor heart rate during the exercise session via a computer screen and to evaluate exercise response after the session is completed to determine whether to increase or decrease the intensity. For the first two weeks, participants will be instructed to stay in the "moderate" range of intensity during the 30 minutes of circuit training. The following four weeks participants will be instructed to increase their effort to vigorous as assessed and determined by the instructor. Moderate intensity is defined as 70-80 percent of estimated maximum heart rate. Vigorous intensity is defined as 80-90 percent estimated maximum heart rate.

Estimated maximum heart rate is determined by: 208-.7 X age. Estimated maximum heart rate will be adjusted for participants on beta blockers or other blood pressure lowering medications (164-.7 X age).

At the end of each exercise session the instructor will complete the data sheet on the daily scripted exercise plan. For example, the instructor will document whether the participant was present, had any adverse events, able to complete the exercises as prescribed etc.

Wait List Control Group 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.

Week #10 (Post Testing): Participants will complete the same surveys and clinical measures as performed during for pre-testing. Post-testing will be approximately 60 minutes. Participants will also be provided qualitative and quantitative questions via an anonymous link and/or QR code to a Qualtrics survey pertaining to their experience and satisfaction with the program.

Quantitative questions will use a rating scale of 1-5 with 1= strongly agree; 2= somewhat agree; 3= neutral; 4; somewhat disagree; 5; strongly disagree. Questions will pertain to usefulness of the program, ease of use, burden of doing the exercises/testing, comprehensibility.

Qualitative questions will be open ended asking about most/least helpful components, met expectations, suggestions for improvement, perceived safety of doing the exercises and testing and intent to continue the exercise program.

Eligibility criteria: 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.

  * required

Primary outcomes:
measure: Fidelity of intervention
timeFrame: 21 months
measure: Intervention Adherence
timeFrame: 21 months
measure: Feasibility of Outcomes
timeFrame: 21 months
measure: Assessment of Data Collection
timeFrame: 21 months
measure: Assessment of Safety
timeFrame: 21 months
measure: Assessment of Participants Perception
timeFrame: 21 months
Secondary outcomes:
measure: Balance
timeFrame: 21 months
measure: Gait
timeFrame: 21 months
measure: Physical Activity
timeFrame: 21 months
measure: Gait Speed
timeFrame: 21 months
measure: Functional Strength
timeFrame: 21 months
measure: Cardiovascular Endurance
timeFrame: 21 Months
measure: Quality of life of Participants
timeFrame: 21 months
measure: Disease Severity
timeFrame: 21 months
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Equilibrium Physical Therapy
state: California
Study officials:
affiliation: California State University, Northridge
name: Andrew S Bartlett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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