Novel Tools for the Delivery and Assessment of Exercise Programs Adapted to Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Technology feasibility
研究概览
简要总结
The study will aim to determine whether a technology-based personalized home exercise program delivered asynchronously and supervised remotely by a kinesiologist is more effective in improving gait than a similar home-based exercise program without technology nor remote supervision. The main hypothesis is that the proposed intervention with the technology will provide significant improvements in gait performance and higher adherence/satisfaction over the non-supervised exercise program.
Both groups will be composed of people with Parkinson's disease. They will have the same evaluation pre and post intervention, the same number of visits from the kinesiologist to deliver the exercise program at home. The difference is the information gathered from the technology; for example, the completion level of each training, success or failure of selected exercises, connection to exercise session, etc. In addition, kinesiologist can remotely adjust difficulty of exercise and take action quickly if the participant hasn't logged in the training system.
Total duration for a participant is 16 weeks: pre-evaluation at home and at lab, 12 weeks home-based exercise program, post-evaluation at home and lab (same as before exercise program).
Pre- and post-evaluation: 7 days wearing an Apple watch to measure mobility in participant environment (participant is met at home and continues normal activities), than comes to lab to undergo physical and balance tests, and scans to analyse body composition (fat, muscle and bone structures). Participant needs to be in "off" state when arriving at the lab; not have taken the morning PD medication. Will take it at the lab with breakfast, after the first tests.
详细描述
The specific aims of this project are: a) to determine whether a technology-based personalized home exercise program delivered asynchronously and supervised remotely by a kinesiologist is more effective in improving gait than a traditional home-based exercise program, b) to assess the system acceptability and satisfaction, c) to examine and compare the impact of both approaches on several secondary outcome measures related to mobility, PD symptom, and quality of life. This study is a prospective randomized controlled single-blinded clinical trial of efficacy of a technology asynchronous assisted supervised tele-exercise program compared to an a traditional home-based exercise program with a booklet.
Interventions:
Control group (CONT): The participants (n=21) included in control group will follow a non-supervised home-based exercise program (booklet format). The exercise program will include 3 physical activity sessions per week for 12 consecutive weeks. This exercise regimen has been shown to be adequate to improve functional capacities in elderly and feasible. Each exercise session will last 40-45 minutes and includes: 1) 5 minutes of warm-up exercises; 2) 15-18 minutes of mobility and balance exercises (e.g. high knees, lateral launches, side steps); 3) 15-18 minutes of strengthening and coordination exercises (e.g. weight transfer and squats, leg extension and balance, lateral shifting, horizontal flexion and extension) and; 4) 5 minutes for cool down/stretching. This exercise protocol was developed based on general guidelines for the prescription of exercises to older adults and, validated in a previous study. The exercise booklet will be introduced and supervised for the first sessions by a trained kinesiologist. Follow-ups by phone will happen at sessions 6, 12 and 18. During these follow-up calls, if the answers are "yes" to the 3 following questions (1. Did the participant perform during the last weeks all the exercise sessions? 2. Did the participant feel safe when performing exercises? 3. Did the participant find easier to perform the exercises compared to the last contact?), then the participant will be invited, but not obligated, to increase the level of difficulty using the option indicated in the booklet.
JIN Group (n=21): The JIN group (n=21) will receive an individualized asynchronous supervised home-base exercise program using the Jintronix System, 3 times/week for 12 weeks (36 sessions). This exercise regimen has shown to be adequate to improve functional capacities in elderly. Briefly, the Jintronix Rehabilitation System (JRS) uses Microsoft Kinect cameras to track patient's movements in 3D during exercises. They are programmed as games that are visualized on a television and for which performance feedback is provided to the participant. Developed by Jintronix system designers in partnership with researchers, the system provides an interactive exergame environment to execute, specialized exercises through specific instructions and real-time feedback. The Jintronix system which includes a computer, the software and a motion capture device will be installed at participants' homes on their own television. A trained kinesiologist will install the system and supervise the exercise program. Participants will be trained to use the system with help of the kinesiologist during the visits. Each exercise session will last 40-45 minutes and includes: 1) 5 minutes of warm-up exercises; 2) 15-18 minutes of mobility and balance exercises (e.g. high knees, lateral launches, side steps); 3) 15-18 minutes of strengthening and coordination exercises (e.g. weight transfer and squats, leg extension and balance, lateral shifting, horizontal flexion and extension) and; 4) 5 minutes for cool down/stretching. Based on the Web-portal daily reports on the performance of the exercise program, the kinesiologist will do online adjustment of the degree of difficulty of the individualized exercises by increasing the number of repetitions, number of series, intensity and range of motion and provide feedback to the participant. This will ensure individualized adaptations and progress throughout the 12-week intervention.
The JIN group will use the Jintronix rehabilitation software to exercise at home whereas the CONT group will use an exercise booklet. Both groups will be free to exercise on the 3 days and times that best suit their schedule, with a mandatory minimum of one day off between sessions. In addition, to counteract human interaction bias, both exercise groups will have the same number and type of contact. The first weeks following the baseline evaluation, 3 to 4 in-person home visits are required to ensure proper and safe execution of exercise protocol (both groups) and the capacity to use the technology (JIN group only). In addition to these visits, 3 follow-up phone calls will be given to allow the kinesiologist to ensure safety and adherence. An emergency contact number will be given to participants for any questions regarding the exercise regimen during the 12-week intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
盲法说明
One of the investigator (the research assistant) will not know the type of intervention (technology or booklet), until the last week of testing when the investigator takes back the equipment for intervention.
入排标准
- 年龄范围
- 55 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PD from a neurologist based on the clinical diagnostic criteria for PD based on the recent work of Postuma and colleagues
- •Hoehn and Yahr stages 1 to 3
- •lives on the island of Montreal
排除标准
- •Unstable medical/psychiatric comorbidities
- •History of other movement disorders
- •Orthopedic conditions restricting exercise
- •Already performing more than 20 minutes of aerobic exercise more than 3 times per week (to avoid prior training effect)
结局指标
主要结局
Technology feasibility
时间窗: 12 weeks
Automated logs from Jintronix system (performance on each exercise-game)
Gait parameters
时间窗: 6 min walk test
Distance walked in 6 min (in meters)
Technology acceptability
时间窗: 12 weeks
Automated logs from Jintronix system (compliance)
次要结局
- Functional capacity(10 minutes)
- Ecological activity(Minimum 7 days)
- Ecological mobility(Minimum 7 days)
研究者
Christian Duval
Professor
Université du Québec a Montréal
