Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older

NCT06983574 | Not Yet Recruiting

• 1 other identifier: HOME-FIT
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 3 months post-intervention

Secondary Outcomes (19)

• 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

Study Arms (2)

MIA intervention

EXPERIMENTAL

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

Other: MIA

No intervention with MIA

NO INTERVENTION

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.

Interventions

MIA OTHER

Through 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.

MIA intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PXL University College: lead

Related Publications (1)

• Quadflieg K, Robijns J, Daniels K. Evaluating the effectiveness of an mHealth application to promote home-based exercise in adults aged 65 years and older: protocol for a randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e106629. doi: 10.1136/bmjopen-2025-106629.

  PMID: 41193218 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 21, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05