HealthyHOME-FITNCT06983574
Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older
A study testing MIA in people with Healthy, run by PXL University College.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MIA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Evaluating the Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older: A Randomized Controlled 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:
Read more
- 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
- Being tested
- MIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIAOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 3 months post-intervention
Secondary outcomes (19)
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.
Measured: From enrollment to the end of intervention at 8 weeks
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.
Measured: From enrollment to the end of intervention at 8 weeks
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.
Measured: From enrollment to the end of intervention at 8 weeks
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.
Measured: From enrollment to the end of intervention at 8 weeks
Fall risk
The Timed Up \& Go test will be conducted to evaluate fall risk. Participants will be observed and timed as they stand up from an armchair, walk three meters, turn around, walk back, and sit down again.
Measured: From enrollment to the end of intervention at 8 weeks
Flexibility
The Sit and Reach test will assess the spinal flexibility and hamstring length/flexibility. Participants will be seated on the floor with their legs extended and feet placed flat against a sit-and-reach box. A measuring scale will be attached to the top of the box. With their hands placed on top of the other, participants will be instructed to reach forward toward their toes as far as possible. The distance reached will be recorded using the measuring scale. The highest value will be used for analysis.
Measured: From enrollment to the end of intervention at 8 weeks
Muscle power
Muscle power will be assessed by the 30 s Sit-to-stand (STS) muscle power test. Briefly, the subjects will perform as many STS repetitions as possible in 30 s on a standardized armless chair from the sitting position-buttocks touching the chair-to the full standing position, with their arms crossed over the chest. Verbal encouragement will be given throughout the test. The participants will be allowed to try one to two times before the definitive measure was annotated.
Measured: From enrollment to the end of intervention at 8 weeks
Daily steps
Daily steps will be assessed using a wearable activity tracker, the Garmin Vivomart 5.
Measured: From enrollment to 3 months post-intervention
IPAQ-SF
The International Physical Activity Questionnaire - Short Form. The total score will be classified into three categories: low, moderate, and high physical activity, according to the IPAQ scoring guidelines.
Measured: From enrollment to the end of intervention at 8 weeks
ESES
The Exercise Self-Efficacy Scale. The total score ranges between 10 and 40. Higher scores represent higher confidence to carry out physycial activity.
Measured: From enrollment to the end of intervention at 8 weeks
BREQ
The Behavioural Regulations in Exercise Questionnaire. The total score will be transformed to a RAI score. Higher score represent higher self determination for physical activity.
Measured: From enrollment to the end of intervention at 8 weeks
PACES
The Physical Activity Enjoyment Scale. The total score ranges between 8 and 56. Higher scores represent greater enjoyment for physical activity.
Measured: From enrollment to the end of intervention at 8 weeks
Cognitive function
The assessment of cognitive functioning will be conducted using the SWAY (SWAY Medical Inc. in Tulsa, OK, USA). The cognitive performance segment of the app encompasses three modules focusing on memory, reaction time, and impulse control. Based on the results, participants will be classified into percentiles ranging from vary low (<10%) to very high (>10%).
Measured: From enrollment to the end of intervention at 8 weeks
WHO-QoL
The World Health Organization Quality of Life questionnaire. The total score ranges between 0 and 100. Higher scores represent higher quality of life.
Measured: From enrollment to the end of intervention at 8 weeks
PSS
The Perceived Stress Scale. The total score ranges between 0 and 40. Higher scores represent higher perceived stress.
Measured: From enrollment to the end of intervention at 8 weeks
GSQ
The Geriatric Sleep Questionnaire. The total score ranges between 6 and 30. Higher scores represent poorer sleep quality.
Measured: From enrollment to the end of intervention at 8 weeks
SUS
The System Usability Scale. The total score ranges between 1 and 100. Higher scores represent high usability.
Measured: From enrollment to the end of intervention at 8 weeks
NPS
The Net Promoter Score. Total score ranges between 1 and 10. Higher scores represent higher loyalty.
Measured: From enrollment to the end of intervention at 8 weeks
CSAT
The Customer Satisfaction Score. Total score ranges between 1 and 5. Higher scores represent higher satisfaction.
Measured: From enrollment to the end of intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PXL University College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983574
- Sponsor's protocol ID
- HOME-FIT
- Acronym
- HOME-FIT
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41193218
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06983574
- Acronym / sponsor ID
- HOME-FIT / HOME-FIT
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- PXL University CollegeUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIA intervention | Experimental | Other: MIAParticipants 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 |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIAThrough 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. | Other | MIA intervention |
Primary outcome
MVPA
Time frame: 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.
19 secondary outcomes
Gait speed
Time frame: From enrollment to the end of intervention at 8 weeks
Quadriceps force
Time frame: From enrollment to the end of intervention at 8 weeks
Handgrip strength
Time frame: From enrollment to the end of intervention at 8 weeks
Balance
Time frame: From enrollment to the end of intervention at 8 weeks
Fall risk
Time frame: From enrollment to the end of intervention at 8 weeks
Flexibility
Time frame: From enrollment to the end of intervention at 8 weeks
Muscle power
Time frame: From enrollment to the end of intervention at 8 weeks
Daily steps
Time frame: From enrollment to 3 months post-intervention
IPAQ-SF
Time frame: From enrollment to the end of intervention at 8 weeks
ESES
Time frame: From enrollment to the end of intervention at 8 weeks
BREQ
Time frame: From enrollment to the end of intervention at 8 weeks
PACES
Time frame: From enrollment to the end of intervention at 8 weeks
Cognitive function
Time frame: From enrollment to the end of intervention at 8 weeks
WHO-QoL
Time frame: From enrollment to the end of intervention at 8 weeks
PSS
Time frame: From enrollment to the end of intervention at 8 weeks
GSQ
Time frame: From enrollment to the end of intervention at 8 weeks
SUS
Time frame: From enrollment to the end of intervention at 8 weeks
NPS
Time frame: From enrollment to the end of intervention at 8 weeks
CSAT
Time frame: From enrollment to the end of intervention at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Derived from this study: PubMed 41193218Quadflieg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MIA in people with Healthy, run by PXL University College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVPA (time frame: From enrollment to 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06983574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.