Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06538298
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-26
Brief Title:
Title A Multimodal Exercise Program With Gamification for Parkinson Disease MEPG
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multimodal Exercise Program With Gamification MEPG in Individuals With Parkinson Disease a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEPG
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 Parkinsons disease The exercise program will consist of strengthening balance aerobic flexibility and the use of a computerized game to challenge participants 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 participants 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 ie 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 instructorresearcher 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 andor 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 exercisestesting comprehensibility
Qualitative questions will be open ended asking about mostleast helpful components met expectations suggestions for improvement perceived safety of doing the exercises and testing and intent to continue the exercise program
The format will consist of a 10-15-minute warm-up of stretching and exercises to gradually warm-up participants 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 ie 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 instructorresearcher 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 andor 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 exercisestesting comprehensibility
Qualitative questions will be open ended asking about mostleast helpful components met expectations suggestions for improvement perceived safety of doing the exercises and testing and intent to continue the exercise program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None