Title: A Multimodal Exercise Program With Gamification for Parkinson Disease (MEP+G) ((MEP+G))
A Multimodal Exercise Program With Gamification (MEP+G) in Individuals With Parkinson Disease: a Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Andrew S Bartlett, PhD
- Phone Number: 5857646717
- Email: Andrew.Bartlett@csun.edu
Study Locations
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California
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Ventura, California, United States, 93003
- Recruiting
- Equilibrium Physical Therapy
-
Contact:
- Amy Griffin, DPT
- Phone Number: 805-339-9718
- Email: agriffin@equilibrium-bpc.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multimodal Exercise Program with Gamification
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. |
A comprehensive exercise program for 3 days a week for 6 weeks that utilizes non-contact boxing and gamification at moderate to vigorous intensity.
|
|
No Intervention: Wait List Control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fidelity of intervention
Time Frame: 21 months
|
Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no".
|
21 months
|
|
Intervention Adherence
Time Frame: 21 months
|
Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no"
|
21 months
|
|
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.
|
21 months
|
|
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.
|
21 months
|
|
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
|
21 months
|
|
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
|
21 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: 21 months
|
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
Time Frame: 21 months
|
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
Time Frame: 21 months
|
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
Time Frame: 21 months
|
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
Time Frame: 21 months
|
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
|
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Cardiovascular Endurance
Time Frame: 21 Months
|
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
Time Frame: 21 months
|
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
Time Frame: 21 months
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Andrew S Bartlett, PhD, California State University, Northridge
Publications and helpful links
General Publications
- Schenkman M, Moore CG, Kohrt WM, Hall DA, Delitto A, Comella CL, Josbeno DA, Christiansen CL, Berman BD, Kluger BM, Melanson EL, Jain S, Robichaud JA, Poon C, Corcos DM. Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease: A Phase 2 Randomized Clinical Trial. JAMA Neurol. 2018 Feb 1;75(2):219-226. doi: 10.1001/jamaneurol.2017.3517.
- Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- El-Kotob R, Giangregorio LM. Pilot and feasibility studies in exercise, physical activity, or rehabilitation research. Pilot Feasibility Stud. 2018 Aug 14;4:137. doi: 10.1186/s40814-018-0326-0. eCollection 2018.
- Landers MR, Ellis TD. A Mobile App Specifically Designed to Facilitate Exercise in Parkinson Disease: Single-Cohort Pilot Study on Feasibility, Safety, and Signal of Efficacy. JMIR Mhealth Uhealth. 2020 Oct 5;8(10):e18985. doi: 10.2196/18985.
- Sangarapillai K, Norman BM, Almeida QJ. Boxing vs Sensory Exercise for Parkinson's Disease: A Double-Blinded Randomized Controlled Trial. Neurorehabil Neural Repair. 2021 Sep;35(9):769-777. doi: 10.1177/15459683211023197. Epub 2021 Jun 13.
- Osborne JA, Botkin R, Colon-Semenza C, DeAngelis TR, Gallardo OG, Kosakowski H, Martello J, Pradhan S, Rafferty M, Readinger JL, Whitt AL, Ellis TD. Physical Therapist Management of Parkinson Disease: A Clinical Practice Guideline From the American Physical Therapy Association. Phys Ther. 2022 Apr 1;102(4):pzab302. doi: 10.1093/ptj/pzab302. Erratum In: Phys Ther. 2022 Aug 1;102(8):pzac098. doi: 10.1093/ptj/pzac098.
- Langbroek-Amersfoort A, Schootemeijer S, Bouten L, Bloem BR, De Vries NM. Exercise Made Accessible: the Merits of Community-Based Programs for Persons with Parkinson's Disease. Curr Neurol Neurosci Rep. 2023 Nov;23(11):695-715. doi: 10.1007/s11910-023-01303-0. Epub 2023 Oct 4.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY24-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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