ClinicalTrials.gg
Not yet recruitingNCT07928934ACTIVE-HFUpdated Nov 10, 2026

Mobile Application to Improve Physical Activity in Patients With Heart Failure

An interventional study of Intervention in Heart Failure and Adherence, sponsored by Abant Izzet Baysal University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Abant Izzet Baysal University · Not applicable, Interventional, and Supportive care

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Heart failure is a chronic condition associated with reduced exercise capacity, physical inactivity, and impaired quality of life. Promoting regular physical activity is an important component of HF management; however, maintaining adequate physical activity levels remains challenging for many patients. Mobile health technologies may provide an effective approach to support physical activity through individualized monitoring, feedback, goal setting, and educational interventions.

The aim of this randomized controlled trial is to evaluate the effect of a mobile application on physical activity behavior in patients with HF.

This single-blind, two-arm randomized controlled trial will be conducted among patients with HF followed at the cardiology outpatient clinics of İzzet Baysal Education and Research Hospital, Bolu, Türkiye. Eligible participants will be randomly assigned to intervention and control groups in a 1:1 ratio.

Participants in the intervention group will use a mobile application integrated with smart wristbands for 12 weeks. The application will enable participants to monitor their physical activity duration and heart rate, set weekly and monthly exercise goals, receive visual feedback, and access educational videos and motivational messages. Before the home-based monitoring period, participants will attend supervised exercise sessions three times per week for one month under the supervision of an expert physiotherapist. These sessions will help determine individualized target heart rate levels, familiarize participants with the application and smart wristbands, and assess exercise tolerance.

Participants in the control group will receive standard care and individualized structured verbal education about the importance of physical activity, practical activity recommendations, and precautions to be considered before, during, and after exercise. They will not receive the technology-supported intervention.

The primary outcome will be the change in physical activity behavior, assessed using the Simple Physical Activity Questionnaire (SIMPAQ). Secondary outcomes will include health-related quality of life, assessed using the Left Ventricular Dysfunction Questionnaire (LVD-36). Physical activity and quality-of-life assessments will be conducted at baseline and during the follow-up period.

This study is expected to provide evidence regarding the potential contribution of mobile application-supported physical activity monitoring to promoting physical activity behavior and improving quality of life among individuals with HF.

Read the detailed description

Heart failure (HF) is a chronic and progressive clinical condition that significantly affects patients' functional capacity, daily activities, and quality of life. Physical inactivity and sedentary behavior are common among individuals with HF and may contribute to further deterioration in functional capacity and overall health status. Regular physical activity is an important component of HF management and is recommended to improve exercise capacity, reduce symptoms, and support patients' ability to maintain daily activities. However, despite the established benefits of physical activity, many patients with HF experience difficulties initiating and maintaining regular physical activity due to symptoms, reduced exercise tolerance, lack of motivation, and insufficient monitoring and support.

In recent years, mobile health technologies and wearable devices have provided new opportunities for supporting physical activity in individuals with chronic diseases. Mobile applications integrated with wearable devices can facilitate continuous monitoring of physical activity and heart rate, provide individualized feedback, support goal setting, and deliver educational and motivational content. These features may help individuals become more aware of their activity patterns, monitor their progress, and develop sustainable physical activity habits. In patients with HF, technology-supported monitoring may also facilitate the identification of periods of reduced activity and provide opportunities for timely communication and support.

This study aims to evaluate the effect of a mobile application integrated with smart wristbands on physical activity behavior in patients with HF. The intervention is designed to support physical activity through individualized exercise goals, heart rate monitoring, visual feedback, educational videos, and motivational messages. The study will also evaluate changes in health-related quality of life following the intervention.

Study Design and Setting

This study is designed as a single-blind, randomized controlled intervention study with two parallel groups: an intervention group and a control group. Participants will be randomly assigned to the groups in a 1:1 ratio. The study will be conducted between December 01, 2026, and March 15, 2027, among patients with HF followed in the cardiology outpatient clinics of İzzet Baysal Education and Research Hospital, Bolu, Türkiye.

Study Population

The study population will consist of individuals diagnosed with HF who attend the cardiology outpatient clinics of the study hospital. Patients who meet the inclusion criteria and agree to participate voluntarily will be enrolled in the study.

The inclusion criteria are:

  • Having a diagnosis of HF confirmed by echocardiography.
  • Having heart failure with reduced ejection fraction (HFrEF).
  • Being between 18 and 75 years of age.
  • Being classified as New York Heart Association (NYHA) functional class I, II, or III.
  • Having no ischemic findings on coronary angiography performed within the previous three months.
  • Having no physical limitations that prevent participation in physical activity.
  • Obtaining a score of 25 or higher on the Standardized Mini-Mental State Examination.
  • Owning a smartphone compatible with the mobile application.

The exclusion criteria are:

  • Being younger than 18 or older than 75 years of age.
  • Having an ischemic lesion requiring revascularization on coronary angiography.
  • Having undergone major cardiac surgery within the previous three months.
  • Experiencing worsening dyspnea or exercise intolerance at rest.
  • Having uncontrolled arrhythmia.
  • Having uncontrolled diabetes (HbA1c ≥ 7).
  • Having chronic pulmonary disease or renal failure.
  • Having symptomatic postural hypotension.
  • Having an Edmonton Frail Scale score of 9 or higher, indicating moderate-to-severe frailty.
  • Having a neuropsychiatric disorder that severely affects cognitive functions such as attention, memory, and comprehension, including dementia or Alzheimer's disease.
  • Being unwilling to participate in the study.

Intervention Group

Participants assigned to the intervention group will receive a mobile application-supported physical activity monitoring intervention integrated with commercially available smart wristbands. The intervention will include supervised exercise sessions, individualized heart rate monitoring, physical activity goal setting, visual feedback, educational content, and motivational messages.

  1. Initial Education and Supervised Exercise Sessions

    At the beginning of the intervention, participants will receive an individual face-to-face training session covering the importance of physical activity in HF, practical recommendations for increasing daily activity, and precautions to be considered before, during, and after physical activity. The educational content will be prepared based on evidence-based scientific sources.

    Following group allocation, participants in the intervention group will attend supervised exercise sessions for one month. These sessions will be conducted three days per week, with each session lasting approximately 50 minutes, under the supervision of an expert physiotherapist.

    During these sessions, participants will be provided with smart wristbands, and the mobile application will be installed on their smartphones. They will receive practical training on how to use the wristbands and application.

    The supervised exercise sessions will serve three main purposes. First, heart rate data will be collected simultaneously through the smart wristbands during exercise sessions. At the end of the one-month supervised period, the average heart rate expected to be reached during exercise or physical activity will be calculated for each participant. This individualized target heart rate will subsequently be displayed on the application's home screen.

    Second, participants will be introduced to basic exercises that can be performed independently at home, particularly under unfavorable weather conditions or when outdoor physical activity is not feasible. These exercises will be demonstrated by the expert physiotherapist, recorded as videos, and uploaded to the application's video section.

    Third, participants' exercise tolerance and the occurrence of potential adverse events will be monitored throughout the supervised exercise period. Observational notes regarding participants' experiences during the sessions will be recorded using a follow-up chart.

  2. Mobile Application Components

The mobile application is designed to support participants in monitoring their physical activity, tracking their progress toward individualized goals, and maintaining regular physical activity behaviors. The application consists of three main screens: the home screen, messages screen, and videos screen.

Home Screen

The home screen includes sections for monitoring physical activity goals, exercise duration, and heart rate data.

Physical activity goals: Participants will be able to view their weekly and monthly physical activity goals. The weekly goal will be set at 150 minutes and the monthly goal at 600 minutes. Participants will be able to monitor their completed activity duration, the remaining time required to reach their goals, and their progress toward the established targets. Changes in physical activity levels and progress toward monthly goals will also be presented through graphical visualizations.

Daily activity confirmation: At 21:00 each day, participants will receive a notification on their smartphones. When they select the notification, they will be directed to the application's home screen, where their activity duration within the target heart rate range will be displayed. For example, the application may display a message such as, "We see that you stayed active for 44 minutes today. Do you confirm?" Participants will be asked to confirm the reported duration. If they have not exercised, they can select the "I did not exercise" option. If their heart rate increased due to a medical condition rather than physical activity, they can select the "I did not exercise because I was feeling unwell" option. This confirmation process will help distinguish physical activity from heart rate increases associated with other health conditions. Participants reporting that they feel unwell may be contacted by telephone for further follow-up.

Heart rate monitoring: Heart rate data obtained from the smart wristband will be displayed on the home screen. Participants will be able to view their heart rate values, compare them with their individually determined target heart rate, and monitor changes through graphical representations. This feature is intended to support participants in monitoring their heart rate during physical activity and performing activities within their individually defined safe limits.

Messages Screen

The messages screen will provide educational, informative, and motivational messages to encourage regular physical activity. Messages will be designed to increase participants' awareness of the benefits of physical activity, support motivation, and encourage the development and maintenance of regular exercise habits.

In addition to routine motivational messages, individualized feedback will be provided to participants who do not regularly confirm their daily activity or who fail to achieve their weekly and monthly exercise goals. Weekly and monthly messages will be used to encourage participants to resume or maintain their physical activity behaviors.

Examples of messages include:

"Remember, small steps make a big difference! Walk an extra 10 minutes today."

"Moving is the best gift for your heart. Come on, let's take some steps!"

"Sitting for long periods can negatively affect your heart health. Now it is time for a short break and stretching."

"Every step brings you closer to a stronger heart. Come on, let's take some steps!"

"Being active today is the key to feeling more energetic tomorrow. Let's start!"

"We noticed that you haven't been active enough this week! How about protecting your heart health with regular physical activity?"

"Congratulations, you have reached this month's activity goals. You are doing very well. We want you to keep it up."

Videos Screen

The videos screen will contain educational materials designed to increase participants' knowledge and awareness of physical activity in HF. The educational content will be developed based on evidence-based scientific sources. In addition, exercise videos recorded by the expert physiotherapist during the supervised exercise sessions will be uploaded to this section. Participants will be able to access these videos and perform the demonstrated exercises independently at home.

Throughout the intervention period, physical activity and heart rate data obtained from smart wristbands will be monitored through the mobile application. The application will provide visual feedback and support participants in tracking their activity levels, reaching their exercise goals, and integrating physical activity into their daily routines.

Control Group

Participants assigned to the control group will receive standard care and individualized structured verbal education. The education will cover the importance and benefits of physical activity in HF, practical recommendations for daily physical activity, and precautions to be considered before, during, and after exercise.

Unlike the intervention group, participants in the control group will not receive the mobile application or smart wristbands as part of the study intervention. Their follow-up assessments will be conducted through telephone contact.

Outcome Measures

Primary Outcome

The primary outcome of the study is the change in physical activity behavior following the mobile application-supported intervention. Physical activity will be assessed using the SIMPAQ.

The SIMPAQ is a validated and reliable instrument designed to assess physical activity and sedentary behavior over the previous seven days. It consists of five self-reported items addressing time spent in bed, sedentary activities, walking, exercise, and incidental daily activities. Moderate-to-vigorous physical activity duration is calculated by summing the reported walking and exercise durations. The Turkish validity and reliability of the questionnaire have been established.

The SIMPAQ will be administered to participants in both groups during the study follow-up period. Participants in the intervention group will access the questionnaire through the mobile application, whereas participants in the control group will complete it through telephone-guided assessment.

Secondary Outcome

The secondary outcome is health-related quality of life. This outcome will be evaluated using the LVD-36. The LVD-36 is a disease-specific questionnaire developed to assess the effects of left ventricular dysfunction on daily life and well-being in individuals with HF. It consists of 36 items with true/false response options. Scores range from 0 to 100, with higher scores indicating poorer quality of life. The Turkish validity and reliability of the questionnaire have been established.

Data Collection

Data will be collected using three instruments:

Introductory Information Form: This researcher-developed form will collect sociodemographic and clinical information, including age, gender, weight, height, marital status, educational status, employment status, household composition, current medical diagnoses, duration of HF diagnosis, smoking and alcohol use, current medications, and symptoms and complaints before hospital admission. This form will be administered at baseline.

SIMPAQ: This questionnaire will be used to assess participants' physical activity and sedentary behavior.

LVD-36: This questionnaire will be used to assess health-related quality of life.

Statistical Analysis

Study data will be analyzed using SPSS statistical software. Descriptive statistics, including means, standard deviations, frequencies, and percentages, will be used to summarize participants' demographic and clinical characteristics. Baseline characteristics of the intervention and control groups will be compared using appropriate parametric or nonparametric statistical tests, including the independent samples t-test or Mann-Whitney U test, and one-way ANOVA or Kruskal-Wallis test, as appropriate.

Changes in physical activity scores measured using the SIMPAQ will be evaluated through repeated measures analysis of variance, considering group and time effects and their interaction. Health-related quality-of-life scores measured using the LVD-36 will be compared between groups using appropriate statistical methods. The findings will be interpreted in relation to the primary and secondary outcomes of the study.

Study Limitations

This study will be conducted at a single center among patients with HF followed at the cardiology outpatient clinics of İzzet Baysal Education and Research Hospital in Bolu, Türkiye. Therefore, the generalizability of the findings to the broader population of individuals with HF may be limited.

02

Conditions studied

  • Heart Failure
  • Adherence

Keywords

  • exercise
  • heart failure
  • mobile applications
  • physical activity
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 82 is close to the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Abant Izzet Baysal University is the lead sponsor of 250 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of heart failure confirmed by echocardiography,
  • Being in the class of heart failure with reduced (HFrEF),
  • Individuals aged between 18-75 years,
  • Demonstrating exercise capacity with (NYHA) Class I, II, or III HF,
  • Absence of ischemic findings on coronary angiography performed within the last three months,
  • Absence of physical limitations preventing physical activity,
  • Standardized score ≥ 25
  • Owning a smartphone capable of running the mobile application.

Exclusion criteria

Exclusion Criteria:

  • Being younger than 18 and older than 75 years of age,
  • Presence of an ischemic lesion requiring revascularization on coronary angiography,
  • History of major cardiac surgery within the last three months,

    • Worsening dyspnea and exercise intolerance at rest,
    • Presence of uncontrolled arrhythmia,
    • Uncontrolled diabetes ( ≥ 7 mg/dl),
    • Presence of chronic pulmonary disease or renal failure,
    • Presence of symptomatic postural hypotension,
    • Edmonton Frail Scale score of 9 and above (indicating moderate-to-severe frailty),
    • Presence of a neuropsychiatric disease where cognitive domains such as attention, memory, and comprehension are severely affected (dementia, Alzheimer's, etc.),
    • Unwillingness to volunteer to participate in the program.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Intervention

    Participants in the intervention group will receive a 12-week mobile application-supported physical activity intervention integrated with smart wristbands. During the first month, they will attend supervised exercise sessions three times weekly (50 minutes per session) under the supervision of an expert physiotherapist. Individual target heart rates will be determined during these sessions. Participants will use the mobile application to monitor physical activity duration and heart rate, track weekly and monthly exercise goals, and receive visual feedback. The application will also provide educational exercise videos, motivational messages, and daily activity confirmation notifications to encourage regular physical activity.

    Behavioral: Intervention

  • No intervention
    Standard care

    Participants in the control group will receive standard care and individualized structured verbal education regarding the importance and benefits of physical activity in heart failure, practical recommendations for daily physical activity, and precautions to be taken before, during, and after exercise. They will not receive the mobile application, smart wristbands, or technology-supported physical activity monitoring intervention. Follow-up assessments will be conducted through telephone contact using the study questionnaires.

Interventions

  • BehavioralIntervention

    The intervention is a 12-week individualized mobile application-supported physical activity program integrated with smart wristbands. Its distinctive components include one month of supervised exercise sessions led by an expert physiotherapist to determine individualized target heart rates, followed by technology-supported monitoring. The application provides real-time heart rate tracking, daily activity confirmation, individualized weekly and monthly exercise goals, graphical feedback, motivational notifications, and evidence-based educational and exercise videos. Participants can monitor their progress and receive tailored feedback to encourage regular physical activity and support long-term exercise adherence.

06

What researchers measure

Primary outcomes

  1. Physical activity behavior

    Physical activity behavior will be assessed using the SIMPAQ, a validated and reliable instrument that evaluates physical activity and sedentary behavior over the previous seven days. The questionnaire consists of five items addressing time spent in bed, sedentary activities, walking, exercise, and incidental daily activities. Moderate-to-vigorous physical activity duration will be calculated by summing the reported walking and exercise durations. Changes in SIMPAQ scores will be evaluated to determine the effect of the mobile application-supported intervention on participants' physical activity behavior. The Turkish version of the SIMPAQ has demonstrated good test-retest reliability, with intraclass correlation coefficients (ICC) ranging from 0.87 to 0.99 across its five items.

    Time frame: from baseline to 3 months

Secondary outcomes

  1. Quality of life

    Health-related quality of life will be assessed using the LVD-36, a disease-specific instrument consisting of 36 true/false items designed to evaluate the impact of heart failure and left ventricular dysfunction on patients' daily lives and well-being. Scores range from 0 to 100, with higher scores indicating poorer quality of life. The Turkish version of the questionnaire has demonstrated acceptable internal consistency, with a Cronbach's alpha coefficient of 0.75.

    Time frame: from baseline to 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Mar 2027, 3 months later.

Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 3 months is below that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 10, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Mar 15, 2027
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07928934
Responsible party
Seyma Demir (Dr, Abant Izzet Baysal University) — Principal investigator
First posted
Nov 10, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 15, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

Seyma Demir Erbas, PhD
Contact
seymademir@ibu.edu.tr
+905464715674
Süleyman Özsarı, PhD
Contact
bolueah1@saglik.gov.tr
0374 253 46 26

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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