About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
MIA
Other interventionThrough a collaborative co-creation process, MIA, a mHealth app was developed and refined over multiple iterations with the goal of promoting physical activity and fostering a lifestyle centred around an active and healthy approach. Content and design were derived from both the co-creative workshops and based on the theoretical framework of the intervention functions of the BCW. The final mHealth app is composed by five major features: * Tailor-made tips * Literacy aiming to improve awareness about PA and an active healthy lifestyle * Exercise workouts * Community calendar aiming to enhance social connections * A diary consisting of daily activities (MIA workouts and self-registration) To customize the user experience, a brief personal description was created as the start screen, which prompts older adults to answer questions related to their baseline physical activity level, motivation, and medical history.
Treatment groups
Trial outcomes
Primary outcomes
MVPA
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.
Secondary outcomes
Gait speed
Gait speed will be measured using the Six Minute Walking Test performed according to the ERS/ATS (22). The absolute distance walked in the test will be used for analysis, and compared with normative values.
Quadriceps force
Isometric quadriceps force will be assessed using the Kinvent®2016 (Kinvent, Montpellier, France) handheld dynamometer. Participants will be tested while sitting in an upright position. The assessor applies resistance and askes the participant to maximally contract the muscle against the resistance. At least three maximal efforts will be performed and the test will be repeated until reproducible measurements (less than 10 % variability) are obtained. The highest value will be used for analyses and compared with normative values.
Handgrip strength
Handgrip strength will be measured isometrically using the K-Force Grip® (Kinvent, Montpellier, France) while sitting in the upright position with the elbow flexed 90◦ and the wrist in a neutral position. Three maximal efforts will be performed and repeated until reproducible measurements (less than 10 % variability) will be obtained. The highest value will be used for analysis and compared with normative values.
Balance
Postural balance will be assessed using the Kinvent PLATES v3® (Kinvent, Montpellier, France). Participants will undergo a double leg balance test three times for 10 seconds with eyes opened and eyes closed, followed by a single leg balance test consisting of three repetitions for each leg with eyes opened.
Locations
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