Heart FailureSTEP-INNCT07204834
A Physical Activity Program for People With Heart Failure
A study testing Physical Activity in people with Heart Failure, run by Universidad de Granada at 4 sites in Spain.
Trial summary
STEP-IN is a research study that examines the effects of a physical activity program designed to increase the daily steps and cadence of patients with heart failure, compared to standard medical care, on functional capacity and other markers related to heart and brain health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesSpain
- Study dates
- 8 Oct 2025to Dec 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic heart failure with reduced ejection fraction, HFrEF, i.e., left ventricular ejection fraction ≤40%, or mildly reduced ejection fraction, HFmrEF, i.e., left ventricular ejection fraction 41-49%, confirmed with an echocardiography showing HFrEF or HFmrEF in the last 6 months and having reached stable medication titration (highest tolerated dose) for ≥1 month
- Functional class New York Heart Association (NYHA) II or III, confirmed by the clinical staff
- Age ≥18 years old
Who cannot join
- Signs or symptoms of decompensated heart failure in the last month
- Uncontrolled arrhythmia
- Limiting angina (grade III or IV)
- Severe symptomatic aortic stenosis
- Persistent symptomatic hypotension
- In the last 3 months: myocardial infarction, revascularization procedure (i.e., percutaneous coronary intervention, coronary artery bypass graft) or insertion of a cardiac device (e.g., implantable cardioverter defibrillator, bi-ventricular pacemaker)
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- Comorbid diagnosed conditions that either contraindicate physical activity or may adversely impact adherence to trial procedures, such as active malignancy, major depression or other significant psychiatric disorders, dementia, or significant hearing or visual impairment
- Inability to walk independently (i.e., requires assistive devices for ambulation)
- Already participates in a clinical trial or plans to participate in other interventions that could affect this trial, such as cardiac rehabilitation, during the study period
- Both the participant and caregiver are unable to access a smartphone or internet, or have null technology literacy (i.e., unable to use WhatsApp or a simple Web page)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites
Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada
Granada, 18016
Hospital Universitario Clínico San Cecilio
Granada
Hospital Universitario Virgen de las Nieves
Granada
Hospital Comarcal Santa Ana de Motril
Motril
About this study
Official title: A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial
STEP-IN is a research study that examines the effects of a physical activity program designed to increase the daily steps and cadence of patients with heart failure, compared to standard medical care, on functional capacity and other markers related to heart and brain health.
The primary hypothesis is that participating in the physical activity program for 9 months will improve functional capacity, the primary clinical measure, significantly more than receiving only the standard medical care in people with heart failure. It is also hypothesized that the physical activity program will have positive effects on symptoms and limitations related to heart failure, inflammation, as well as heart and brain health.
Read the detailed description
Heart failure is associated with disabling symptoms of dyspnea, fatigue, low exercise tolerance, and frequent hospitalizations. Managing heart failure is challenging, as it often coexists with several comorbidities related to cardiovascular- and brain-health (e.g., hypertension, dyslipidemia, cognitive impairment). Physical activity programs represent a promising adjuvant to pharmacological treatments to improve patients' functional capacity, reduce their symptoms, and facilitate long-term physical activity maintenance as patients' exercise tolerance improves. However, few patients with heart failure attend and adhere to traditional structured exercise programs such as cardiac rehabilitation. In response, the overall objective of STEP-IN is to design and test the effectiveness, feasibility and safety of a real-world, individualized step-based physical activity intervention to improve functional capacity, heart failure symptoms and limitations, systemic inflammation and additional heart-brain outcomes in patients with heart failure.
STEP-IN is a two-arm, single-blind multicenter randomized controlled trial. A total of 200 adults with heart failure with reduced (≤40%) or mildly reduced ejection fraction (41-49%) and a II or III NYHA functional class will be enrolled. Participants will be randomized 1:1 to a 9-month step-based physical activity intervention or enhanced usual care. The intervention will leverage wearable devices and a personalized online platform alongside behavior change methods to progressively increase participants' daily step count (volume) and step cadence (intensity), with increments individually planned every 2 weeks. To test the effectiveness of the program all participants will undergo several evaluations at baseline, and 3, 9 and 12 months after randomization, with the main timepoint of interest being from baseline to 9-month follow-up.
- Conditions
- Heart Failure
- Being tested
- Physical Activity
- Keywords
- Exercise, Physical activity, Step, Cadence, Cardiovascular disease, Heart-brain, 6-minute walk test, Walking, Wearable, Fitbit
- Medical subject headings
- Heart Failure, Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityBehavioural
Also called Exercise
Participants will be encouraged to progressively increase the number of daily steps (volume) and the number of minutes per day spent at a higher cadence (intensity). To achieve these goals, the investigators will support participants in the intervention group through behavior change techniques. For example, wearable devices and an online platform will be used to monitor the behavior and track progress using simple graphs; participants will be provided with small, individualized goals which will be updated every two weeks based on the activity levels achieved the prior two weeks; standardized WhatsApp messages will be sent to prompt the behavior and face-to-face coaching sessions will be delivered throughout the intervention.
Participants in this group will also receive enhanced usual care, consisting of the usual care to manage heart failure plus an education pamphlet and in-depth evaluations and reports to measure the project outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity | Experimental | 9-month remotely-monitored, goal-oriented, individualized, step-based physical activity program. Receives: Behavioral: Physical Activity |
| Enhanced usual care to manage heart failure | No intervention | Participants will receive enhanced usual care, consisting of the usual care to manage heart failure (guideline-directed medical therapy) plus an education pamphlet and in-depth evaluations and reports to measure the project outcomes. Specifically, usual care for heart failure generally encompasses optimized treatment titration, patient education and self-management strategies, nurse-led clinical assessments and medication adjustments, monitoring of patient outcomes, and coordinated collaboration with primary care and other specialties. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional capacity
The primary outcome is the change in functional capacity measured with a 6-minute walk test (6MWT).
Measured: Baseline, 3 months, 9 months and 12 months
Secondary outcomes (7)
Change in patient-perceived heart failure-related symptoms and limitations
Measured with the Kansas City Cardiomyopathy Questionnaire - Clinical Summary Scale (KCCQ-CSS). This is scored on a 0-100 scale, with higher scores indicating better heart failure-related health status (i.e., fewer symptoms and less physical limitation); 0 reflects the worst and 100 the best status.
Measured: Baseline, 3 months, 9 months and 12 months
Change in systemic inflammation
Measured with blood-based high-sensitivity C-reactive protein (hs-CRP). Unit: mg/L.
Measured: Baseline and 9 months
Change in additional pro- and anti-inflammatory markers
Additional pro- and anti-inflammatory markers will be measured from a blood sample, e.g., Interleukin-6 (IL-6), Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1 beta (IL-1β), Interleukin-10 (IL-10), and Interleukin-1 Receptor Antagonist (IL-RA), including novel inflammatory biomarkers that may become available up to the time of analysis.
Unit: pg/mL.
Measured: Baseline and 9 months
Change in counts of steps
Measured with a StepWatch accelerometer as the total counts of steps/day.
Measured: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in time spent at light, moderate and vigorous-intensity step cadence
Measured with a StepWatch accelerometer as minutes/day spent at light, moderate (main interest) and vigorous-intensity step cadence.
Measured: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in peak cadence
Measured with a StepWatch accelerometer as the minute with the higher number of steps.
Measured: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in 24-hour movement behaviors
Physical activity (primary behavior of interest), sedentary, and sleep metrics measured with a Matrix Activity Monitor .
Measured: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start8 Oct 2025
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Hospital Universitario Clínico San Cecilio, Hospital Santa Ana de Motril, Mind, Brain and Behaviour Research Centre (CIMCYC), Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Department of Medical BioSciences, Exercise Physiology ResearchGroup, Radboud University Medical Center, Nijmegen, The Netherlands, Instituto de Investigación Biosanitaria IBS Granada
- Responsible party
- Principal investigator, Francisco B. Ortega Porcel, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204834
- Sponsor's protocol ID
- SPID202300X148404IV0
- Acronym
- STEP-IN
- Status last verified
- Nov 2025
- First submitted
- 12 Sep 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol and statistical analyses plan will be shared open access. Data files including individual participant data (IPD) and their corresponding data dictionaries will be shared under restricted access and upon reasonable request (contact Prof. FB Ortega) due to privacy issues and GDPR regulations. IPD will be available for sharing under the "as open as possible, as closed as necessary" principle. The shared data files will be pseudonymized and include only participants who provided informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Step-Based Physical Activity Intervention in Patients With Heart Failure: The STEP-IN Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07204834
- Acronym / sponsor ID
- STEP-IN / SPID202300X148404IV0
- Conditions
- Heart Failure
- Keywords
- Exercise, Physical activity, Step, Cadence, Cardiovascular disease, Heart-brain, 6-minute walk test, Walking
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Hospital Universitario Clínico San Cecilio, Hospital Santa Ana de Motril, Mind, Brain and Behaviour Research Centre (CIMCYC), Centro de Investigación Biomédica en Red de Fisiopatología de la Obesidad y Nutrición, Department of Medical BioSciences, Exercise Physiology ResearchGroup, Radboud University Medical Center, Nijmegen, The Netherlands, Instituto de Investigación Biosanitaria IBS Granada
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Oct 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.
STEP-IN is a research study that examines the effects of a physical activity program designed to increase the daily steps and cadence of patients with heart failure, compared to standard medical care, on functional capacity and other markers related to heart and brain health.
The primary hypothesis is that participating in the physical activity program for 9 months will improve functional capacity, the primary clinical measure, significantly more than receiving only the standard medical care in people with heart failure. It is also hypothesized that the physical activity program will have positive effects on symptoms and limitations related to heart failure, inflammation, as well as heart and brain health.
Detailed description
Heart failure is associated with disabling symptoms of dyspnea, fatigue, low exercise tolerance, and frequent hospitalizations. Managing heart failure is challenging, as it often coexists with several comorbidities related to cardiovascular- and brain-health (e.g., hypertension, dyslipidemia, cognitive impairment). Physical activity programs represent a promising adjuvant to pharmacological treatments to improve patients' functional capacity, reduce their symptoms, and facilitate long-term physical activity maintenance as patients' exercise tolerance improves. However, few patients with heart failure attend and adhere to traditional structured exercise programs such as cardiac rehabilitation. In response, the overall objective of STEP-IN is to design and test the effectiveness, feasibility and safety of a real-world, individualized step-based physical activity intervention to improve functional capacity, heart failure symptoms and limitations, systemic inflammation and additional heart-brain outcomes in patients with heart failure.
STEP-IN is a two-arm, single-blind multicenter randomized controlled trial. A total of 200 adults with heart failure with reduced (≤40%) or mildly reduced ejection fraction (41-49%) and a II or III NYHA functional class will be enrolled. Participants will be randomized 1:1 to a 9-month step-based physical activity intervention or enhanced usual care. The intervention will leverage wearable devices and a personalized online platform alongside behavior change methods to progressively increase participants' daily step count (volume) and step cadence (intensity), with increments individually planned every 2 weeks. To test the effectiveness of the program all participants will undergo several evaluations at baseline, and 3, 9 and 12 months after randomization, with the main timepoint of interest being from baseline to 9-month follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity | Experimental | Behavioral: Physical Activity9-month remotely-monitored, goal-oriented, individualized, step-based physical activity program. |
| Enhanced usual care to manage heart failure | No intervention | –Participants will receive enhanced usual care, consisting of the usual care to manage heart failure (guideline-directed medical therapy) plus an education pamphlet and in-depth evaluations and reports to measure the project outcomes. Specifically, usual care for heart failure generally encompasses optimized treatment titration, patient education and self-management strategies, nurse-led clinical assessments and medication adjustments, monitoring of patient outcomes, and coordinated collaboration with primary care and other specialties. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic heart failure with reduced ejection fraction, HFrEF, i.e., left ventricular ejection fraction ≤40%, or mildly reduced ejection fraction, HFmrEF, i.e., left ventricular ejection fraction 41-49%, confirmed with an echocardiography showing HFrEF or HFmrEF in the last 6 months and having reached stable medication titration (highest tolerated dose) for ≥1 month
- Functional class New York Heart Association (NYHA) II or III, confirmed by the clinical staff
- Age ≥18 years old
Key exclusion criteria (10 listed)
- Signs or symptoms of decompensated heart failure in the last month
- Uncontrolled arrhythmia
- Limiting angina (grade III or IV)
- Severe symptomatic aortic stenosis
- Persistent symptomatic hypotension
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 |
|---|---|---|
| Physical ActivityAlso: ExerciseParticipants will be encouraged to progressively increase the number of daily steps (volume) and the number of minutes per day spent at a higher cadence (intensity). To achieve these goals, the investigators will support participants in the intervention group through behavior change techniques. For example, wearable devices and an online platform will be used to monitor the behavior and track progress using simple graphs; participants will be provided with small, individualized goals which will be updated every two weeks based on the activity levels achieved the prior two weeks; standardized WhatsApp messages will be sent to prompt the behavior and face-to-face coaching sessions will be delivered throughout the intervention. Participants in this group will also receive enhanced usual care, consisting of the usual care to manage heart failure plus an education pamphlet and in-depth evaluations and reports to measure the project outcomes. | Behavioural | Physical Activity |
Primary outcome
Change in functional capacity
Time frame: Baseline, 3 months, 9 months and 12 months
The primary outcome is the change in functional capacity measured with a 6-minute walk test (6MWT).
7 secondary outcomes
Change in patient-perceived heart failure-related symptoms and limitations
Time frame: Baseline, 3 months, 9 months and 12 months
Change in systemic inflammation
Time frame: Baseline and 9 months
Change in additional pro- and anti-inflammatory markers
Time frame: Baseline and 9 months
Change in counts of steps
Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in time spent at light, moderate and vigorous-intensity step cadence
Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in peak cadence
Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
Change in 24-hour movement behaviors
Time frame: Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months
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 18 Nov 2025.
- Individual participant dataSharing planned: Yes. The protocol and statistical analyses plan will be shared open access. Data files including individual participant data (IPD) and their corresponding data dictionaries will be shared under restricted access and upon reasonable request (contact Prof. FB Ortega) due to privacy issues and GDPR regulations. IPD will be available for sharing under the "as open as possible, as closed as necessary" principle. The shared data files will be pseudonymized and include only participants who provided informed consent.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Heart Failure, run by Universidad de Granada at 4 sites in Spain.
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 3 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in functional capacity (time frame: Baseline, 3 months, 9 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.