Clinical trial NCT06983574: Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older
Official title: Evaluating the Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: PXL University College
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: MVPA
timeFrame: From enrollment to 3 months post-intervention
Secondary outcomes:
measure: Gait speed
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Quadriceps force
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Handgrip strength
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Balance
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Fall risk
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Flexibility
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Muscle power
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Daily steps
timeFrame: From enrollment to 3 months post-intervention
measure: IPAQ-SF
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: ESES
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: BREQ
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: PACES
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: Cognitive function
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: WHO-QoL
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: PSS
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: GSQ
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: SUS
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: NPS
timeFrame: From enrollment to the end of intervention at 8 weeks
measure: CSAT
timeFrame: From enrollment to the end of intervention at 8 weeks
Other outcomes:
Locations:
Study officials:
References: