Evaluating the Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 主要终点
- MVPA
研究概览
简要总结
The goal of this clinical trial is to learn if drug ABC works to evaluate the effectiveness of an mHealth application to promote home-based exercise in adults aged 65 and older. The objectives are:
Primary objective:
• To evaluate the effect of the mHealth application on increasing moderate-to-vigorous physical activity levels.
Secondary objectives:
- To assess the impact of the mHealth application on physical fitness measures (e.g., functional capacity, strength, balance, fall risk, flexibility)
- To assess the impact of the mHealth application on physical activity (e.g., daily steps, self-reported physical activity)
- To examine the impact of the mHealth application on wellbeing
- To explore the impact of the mHealth application on cognitive functioning
- To measure user adherence and engagement with the mHealth application
- To evaluate participant satisfaction with the mHealth application
Researchers will compare a group using an mHealth application to a group not using the application to determine whether it effectively increases physical activity.
Participants will:
- Use the mHealth application or not for 8 weeks
- Visit the labo 3 times in total for assessements
- Use a wearable during the study period
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •65 years or older
- •Medically stable Any existing chronic illnesses (e.g., hypertension, diabetes, or arthritis) are being effectively managed with medications or lifestyle interventions.
- •The participant is not experiencing any recent or ongoing acute medical conditions, such as infections, recent surgeries, or injuries, that could interfere with participation in the study.
- •No significant cognitive, mental or physical impairment that would prevent safe use of the mHealth application or performance of the exercises.
- •Understanding and speaking Dutch
- •Access to a smartphone and computer.
排除标准
- •The presence of an active lifestyle.
- •Enrolment in other exercise programs or clinical trials that might interfere with study participation or outcomes.
- •Any condition or circumstance deemed by a healthcare professional to pose a risk to the participant's safety or the validity of the study.
研究组 & 干预措施
No intervention with MIA
Participants in the control group will be instructed to maintain their usual physical activity, dietary habits, and sleep patterns for the 8-week study duration. They will be asked to refrain from engaging in any specialized exercise training during this time.
MIA intervention
Participants will use the mHealth app to engage in home-based workouts aimed at promoting physical activity. The app provides exercises lasting approximately 12-15 minutes each, which participants are encouraged to perform regularly to achieve a total of at least 150 minutes of moderate-to-vigorous physical activity per week. The intervention period spans 8 weeks, during which participants should follow the app's guidance to complete the recommended workouts and track their progress. Participan
干预措施: MIA (Other)
结局指标
主要结局
MVPA
时间窗: From enrollment to 3 months post-intervention
Moderate-to-vigorous physical activity (MVPA) will be assessed using a wearable activity tracker, the Garmin Vivomart 5, which allows for continuous, 24/7 monitoring of physical activity. This device tracks various types of movement throughout the day, providing comprehensive data on activity levels and enabling detailed analysis of participants' physical activity patterns over time.
次要结局
- NPS(From enrollment to the end of intervention at 8 weeks)
- Gait speed(From enrollment to the end of intervention at 8 weeks)
- Quadriceps force(From enrollment to the end of intervention at 8 weeks)
- Handgrip strength(From enrollment to the end of intervention at 8 weeks)
- Balance(From enrollment to the end of intervention at 8 weeks)
- Fall risk(From enrollment to the end of intervention at 8 weeks)
- Flexibility(From enrollment to the end of intervention at 8 weeks)
- Muscle power(From enrollment to the end of intervention at 8 weeks)
- Daily steps(From enrollment to 3 months post-intervention)
- IPAQ-SF(From enrollment to the end of intervention at 8 weeks)
- ESES(From enrollment to the end of intervention at 8 weeks)
- BREQ(From enrollment to the end of intervention at 8 weeks)
- WHO-QoL(From enrollment to the end of intervention at 8 weeks)
- PACES(From enrollment to the end of intervention at 8 weeks)
- Cognitive function(From enrollment to the end of intervention at 8 weeks)
- PSS(From enrollment to the end of intervention at 8 weeks)
- GSQ(From enrollment to the end of intervention at 8 weeks)
- SUS(From enrollment to the end of intervention at 8 weeks)
- CSAT(From enrollment to the end of intervention at 8 weeks)