A Multimodal Exercise Program With Gamification (MEP+G) in Individuals With Parkinson Disease: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Fidelity of intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Multimodal Exercise Program with Gamification (Other)
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.
结局指标
主要结局
Fidelity of intervention
时间窗: 21 months
Participants completing exercises as prescribed: measured using the daily exercise plan as a "yes" or "no".
Intervention Adherence
时间窗: 21 months
Measured by daily exercise plan; instructors will indicate whether participant was present as a "yes" or "no"
Feasibility of Outcomes
时间窗: 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 Safety
时间窗: 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 Data Collection
时间窗: 21 months
Data collection: measured using a pre-populated form and marked as a "yes" or "no" by the PI.
Assessment of Participants Perception
时间窗: 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
次要结局
- Physical Activity(21 months)
- Balance(21 months)
- Gait(21 months)
- Gait Speed(21 months)
- Functional Strength(21 months)
- Cardiovascular Endurance(21 Months)
- Quality of life of Participants(21 months)
- Disease Severity(21 months)