A Physical Activity Program for People With Heart Failure

NCT07204834 | Enrolling By Invitation

• 1 other identifier: SPID202300X148404IV0
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Heart Failure

Keywords

Exercise; Physical activity; Step; Cadence; Cardiovascular disease; Heart-brain; 6-minute walk test; Walking; Wearable; Fitbit

Outcome Measures

Primary Outcomes (1)

• Change in functional capacity

  The primary outcome is the change in functional capacity measured with a 6-minute walk test (6MWT).

  Baseline, 3 months, 9 months and 12 months

Secondary Outcomes (7)

• Change in patient-perceived heart failure-related symptoms and limitations

  Baseline, 3 months, 9 months and 12 months

• Change in systemic inflammation

  Baseline and 9 months

• Change in additional pro- and anti-inflammatory markers

  Baseline and 9 months

• Change in counts of steps

  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

  Baseline, 3 months, 9 months (within the last 2 weeks of the intervention) and 12 months

Other Outcomes (76)

• Change in additional heart failure-related patient perceptions

  Baseline, 3 months, 9 months and 12 months

• Change in general cognition

  Baseline and 9 months

• Change in processing speed

  Baseline and 9 months

Study Arms (2)

Physical Activity

EXPERIMENTAL

9-month remotely-monitored, goal-oriented, individualized, step-based physical activity program.

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.

Interventions

Physical Activity BEHAVIORAL

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.

Also known as: Exercise

Physical Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Universidad de Granada: lead
• Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada, Spain: collaborator
• University Hospital Virgen de las Nieves: collaborator
• Hospital Universitario Clínico San Cecilio: collaborator
• Hospital Santa Ana de Motril: collaborator
• Mind, Brain and Behaviour Research Centre (CIMCYC): collaborator
• Centro de Investigación Biomédica en Red Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, Spain: collaborator
• Department of Medical BioSciences, Exercise Physiology ResearchGroup, Radboud University Medical Center, Nijmegen, The Netherlands: collaborator
• Instituto de Investigación Biosanitaria IBS Granada: collaborator

Study Sites (4)

Department of Physical Education and Sports, Faculty of Sport Sciences, Sport and Health University Research Institute (iMUDS), University of Granada

Granada, 18016, Spain

Location

Hospital Universitario Clínico San Cecilio

Granada, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital Comarcal Santa Ana de Motril

Motril, Spain

Location

MeSH Terms

Conditions

Heart Failure; Motor Activity; Cardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Given the nature of the intervention, participants cannot be blinded to their assigned group. Staff conducting the evaluations will be blinded to the participants' allocation group. Staff conducting statistical analyses for the main outcomes will also be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 2, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD data will be available 12 months after the primary outcome paper is published, upon reasonable request.
• Access Criteria: The specific process of data access will be determined at a later stage. Data will be available upon reasonable request to the PI (FB Ortega). The data requests must contain the aim of the research, hypothesis, the specific data being requested, and a data analysis plan. Based on the "as open as possible, as closed as necessary" principle, we will decide whether the data can be shared. A data access committee will be created to discuss and approve any data requests.

Locations

ES (4)