Gingko Active App-based Personalized Exercise Training for Middle-Aged and Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- App-based physical assessments of strength
研究概览
简要总结
The purpose of this study is to investigate the effectiveness and usability of a Gingko app based exercise training in middle and older aged adults. The main question it aims to answer is if the personalized Gingko app-based exercise is more effective in improving overall physical function than self-guided training with the NIA exercise booklet.
详细描述
Individuals aged >45 years will be recruited. All participants will complete app-based and other assessments at 3 time points(baseline, 6 weeks into the intervention, and after 12 weeks of intervention). Each participant will be asked to perform 3-4 sessions of exercise per week for 12 weeks. Participants will be randomly assigned to receive either the Gingko app-based exercise raining or NIA booklet based exercise training.
The following assessments will be performed: App-based physical assessments of strength, aerobic capacity, and balance, International Physical Activity Questionnaire (IPAQ) to assess physical activity levels, Short Form-12 (SF-12) to assess the quality of life ,Likert scale ratings and open-ended questions to assess user satisfaction and acceptability, Self-Efficacy Exercise Scale (SEE) to assess patient reported exercise self-efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 45 years
- •Independent community ambulation with or without straight cane
- •Able to follow 3 step commands
- •WiFi access at home
排除标准
- •Medical contraindications to exercise (including terminal illness, uncontrolled arrhythmias, recent myocardial infarction, unstable angina, unstable cardiovascular disease or other unstable medical condition)
- •Significant musculoskeletal or neurological disorders as indicated by limitations in activities of daily life (i.e., <6 score on the Katz Index)
- •Participation in other clinical trial within 6 weeks
研究组 & 干预措施
Gingko App-Based Exercise
Participants will be provided with an Apple iPad with access to the Ginkgo Active app, a weight-measuring scale, and a step counter wearable device at the baseline assessment session. Research staff will provide education on app navigation, exercise execution, and safety considerations during this session. Along with the exercises, the participants will also be instructed to wear the step counter every day and log their weight every week.The Ginkgo Active app will personalize each participant's exercises based on an initial assessment, including functional tests to assess balance, cardiovascular fitness, and strength. Participants will complete their weekly training by following the guided exercises. Reassessments will be conducted through the app every 4 weeks to generate updated prescriptions.The app provides real-time feedback during exercise and allow users to report any exercises that cause discomfort, with the algorithm adjusting the exercise prescription accordingly.
干预措施: Ginkgo App-based Exercise Training (Combination Product)
NIA Booklet Based Exercise
Participants will be provided with NIA exercise booklet, a weight-measuring scale, and a step counter wearable device at the baseline assessment session. Participants will receive the National Institute on Aging (NIA) recommended exercise booklet at the baseline assessment session. Research staff will review the booklet content and provide education on proper exercise execution and safety considerations. Participants will be asked to follow the exercises outlined in the booklet 3-4 times per week for 12 weeks. Participants will be provided with a paper log to record the date, duration, and any comments about each exercise session. The log will be reviewed at mid-point assessments and collected at the final assessment visit.
After their 12 weeks of control group training, the participants will then cross over to the experimental group and receive the Ginkgo app-based training.
干预措施: NIA Booklet Exercise (Combination Product)
结局指标
主要结局
App-based physical assessments of strength
时间窗: Change from baseline physical assessment at 12 weeks
The Ginkgo Active app will instruct and guide participants through a standardized upper-body, lower-body, and core exercise, measuring strength by repetitions completed within a set time or by the duration a position is held (based on the exercise and muscle group being tested)
App-based physical assessments of endurance
时间窗: Change from baseline physical assessment at 12 weeks
The Ginkgo Active app will instruct and guide participants through an endurance assessment using the Step-in-Place test. The participant stands upright next to a wall and positions one hand at a height midway between the patella (kneecap) and the iliac crest (top of the hip bone). The participant then marches in place for a specified duration, lifting the knees to the height of the hand. Rest breaks are permitted, and participants may hold onto the wall or a stable chair for balance. Endurance is assessed by recording the total number of times the right knee reaches the target hand height
App-based physical assessments of balance
时间窗: Change from baseline physical assessment at 12 weeks
The Ginkgo Active app will instruct and guide participants through a balance assessment using the single-leg stance test. Participants will be asked to maintain balance on one leg for up to 30 seconds. Performance is interpreted as follows: holding the position for less than 10 seconds indicates a need for balance training, whereas maintaining the position for 25-30 seconds indicates good, stable balance.
Weight Measurement
时间窗: Change from baseline physical assessment at 12 weeks
The weight will measured in kilograms
次要结局
- International Physical Activity Questionnaire (IPAQ)(Change from Baseline IPAQ score at 12 weeks)
- Short Form-12 (SF-12)(Change from Baseline SF-12 at 12 weeks)
- Participant Acceptability and Satisfaction(At the end of 12 weeks)
- Self-Efficacy Exercise Scale (SEE)(Change from Baseline SEE score at 12 weeks)
研究者
Kelly Westlake
Professor
University of Maryland, Baltimore