Heart FailureRAP-ICNCT07350941
Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure
A study testing Cardiac rehabilitation program in people with Heart Failure, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
The aim of the study is to evaluate whether a tailored cardiac rehabilitation program, initiated during hospitalization and continued after discharge, can improve functional capacity, mobility, and quality of life in patients over 65 years old with heart failure. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2026to Jan 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients hospitalized for acute heart failure in a stable phase (on a stable dose or tapering intravenous diuretics for at least 48 hours, without intravenous inotropes or vasodilators for >72 hours).
- Baseline functional class II-III
- Age ≥ 65 years
- Able to walk >4 meters
- Any range of left ventricular ejection fraction
Who cannot join
- Moderate to severe dementia
- Cardiac or other disease with a life expectancy <12 months
- Institutionalized patients or unable to travel to the rehabilitation center
- Functional class I or IV
- Uncontrolled arrhythmias
- Inability to perform a basic exercise protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Margarita Calvo-Lopez, MD, +34637090285, margarita.calvo@salud.madrid.org
Juan Carlos López Azor, MD, PhD, +34 628026462, lopez.gcia.juan.carlos@gmail.com
About this study
Official title: RAP-IC Study: Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure
The aim of the study is to evaluate whether a tailored cardiac rehabilitation program, initiated during hospitalization and continued after discharge, can improve functional capacity, mobility, and quality of life in patients over 65 years old with heart failure.
Read the detailed description
If you meet the inclusion criteria and wish to participate, an initial assessment of your clinical and functional status will be conducted during your hospital stay. A computer system will then randomly assign you to one of the following groups:
Cardiac Rehabilitation Group (treatment group): You will participate in a mild exercise program during hospitalization (Phase I), including mobility and respiratory exercises adapted to your clinical condition. After discharge, you will enter a structured in-person cardiac rehabilitation program (Phase II) lasting 3 months, consisting of two 1-hour exercise sessions per week (aerobic, strength, inspiratory, and proprioceptive exercises) plus one weekly educational session.
Usual Care Group (control group): You will receive standard recommendations for physical activity and general care.
At the end of the study, a final consultation will be conducted to assess differences between the two groups in functional capacity and quality of life.
- Conditions
- Heart Failure
- Being tested
- Cardiac rehabilitation program
- Keywords
- Heart Failure, Cardiac rehabilitation, Cardiopulmonary stress test, Functional capacity
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitation programOther
Cardiac rehabilitation program, in which patients will attend in person twice weekly (Mondays and Wednesdays or Tuesdays and Thursdays), in groups of up to 8 patients, for 1-hour exercise sessions including aerobic, resistance, respiratory, and balance/proprioceptive components. Sessions will be monitored and supervised by cardiologists, rehabilitation physicians, and physiotherapists. In addition, patients will attend one weekly in-person educational session throughout the 3-month program.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation group (treatment group) | Experimental | 3 months of a cardiac rehabilitation program, in which patients will attend in person twice weekly (Mondays and Wednesdays or Tuesdays and Thursdays), in groups of up to 8 patients, for 1-hour exercise sessions including aerobic, resistance, respiratory, and balance/proprioceptive components. Sessions will be monitored and supervised by cardiologists, rehabilitation physicians, and physiotherapists. In addition, patients will attend one weekly in-person educational session throughout the 3-month program. Receives: Other: Cardiac rehabilitation program |
| No intervention group | No intervention | General exercise and educational recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Change in Peak Oxygen Uptake
Change in peak oxygen uptake measured by treadmill cardiopulmonary exercise testing (peak VO₂, measured in ml/kg/min).
Measured: 3 months
Secondary outcomes (14)
Change in Functional Permormance assessed by the Short Physical Performance Battery (SPPB) score
Change in the Short Physical Performance Battery (SPPB) score, ranging from 0 (worst physical performance) to 12 (best physical performance).
Measured: 3 months
Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) score
Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) overall summary score, ranging from 0 (worst health status) to 100 (best health status)
Measured: 3 and 6 months
Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).
Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).
Measured: 3 and 6 months
Change in caregiver burden assessed by the Zarit scale
Change in caregiver burden assessed by the 22-item Zarit Burden Interview (ZBI-22) score (range 0-88, with higher scores indicating greater caregiver burden)
Measured: 3 and 6 months
Change in body composition parameters assessed by bioelectrical impedance analysis (BIA)
Change in body composition parameters expressed as percentages (%), assessed by bioelectrical impedance analysis (BIA)
Measured: 3 and 6 months
Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up
All-cause mortality will be confirmed by medical records or death certificate. Heart failure decompensation will be defined as worsening of heart failure symptoms requiring urgent medical visit, treatment adjustment, or hospital admission. Heart failure-related hospitalizations will be collected from hospital records. Data will be aggregated as the number and percentage of participants experiencing each event during the study period
Measured: 3 and 6 months
Change in Frailty status assessed by FRAIL scale
Change in FRAIL scale (range 0-5, higher scores indicate greater frailty)
Measured: 3 and 6 months
Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS)
Change in emotional status, measured using the Hospital Anxiety and Depression Scale (HADS), with subscales for anxiety and depression ranging from 0 to 21, where higher scores indicate greater symptom severity
Measured: 3 and 6 months
Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score
Change in nutritional status, assessed using the Mini Nutritional Assessment (MNA) score (range 0-30, with higher scores indicating better nutritional status)
Measured: 3 and 6 months
Change in Maximal Inspiratory Pressure (MIP)
Change in maximal inspiratory pressure (MIP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength
Measured: 3 and 6 months
Patient satisfaction
Patient satisfaction with the cardiac rehabilitation program, rated from 0 to 10, being 10 the highest mark
Measured: 6 months
Patient adherence
Patient adherence to cardiac rehabilitation sessions, rated from 0 to 100%, being 100% the highest mark
Measured: 3 months
Change in basic functional independence assessed by the Barthel Index
Change in basic functional independence assessed by the Barthel Index (range 0-100, with higher scores indicating greater independence)
Measured: 3 and 6 months
Change in maximal expiratory pressure (MEP)
Change in maximal expiratory pressure (MEP) measured in cmH₂O, with higher values indicating greater respiratory muscle strength
Measured: 3 ad 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margarita Calvo López, Puerta de Hierro University Hospital
- Investigators
- Margarita Calvo-LOpez, MD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350941
- Sponsor's protocol ID
- PI 195/25
- Acronym
- RAP-IC
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RAP-IC Study: Impact of Cardiac Rehabilitation Adapted for Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07350941
- Acronym / sponsor ID
- RAP-IC / PI 195/25
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac rehabilitation, Cardiopulmonary stress test, Functional capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Jan 2026 (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 aim of the study is to evaluate whether a tailored cardiac rehabilitation program, initiated during hospitalization and continued after discharge, can improve functional capacity, mobility, and quality of life in patients over 65 years old with heart failure.
Detailed description
If you meet the inclusion criteria and wish to participate, an initial assessment of your clinical and functional status will be conducted during your hospital stay. A computer system will then randomly assign you to one of the following groups:
Cardiac Rehabilitation Group (treatment group): You will participate in a mild exercise program during hospitalization (Phase I), including mobility and respiratory exercises adapted to your clinical condition. After discharge, you will enter a structured in-person cardiac rehabilitation program (Phase II) lasting 3 months, consisting of two 1-hour exercise sessions per week (aerobic, strength, inspiratory, and proprioceptive exercises) plus one weekly educational session.
Usual Care Group (control group): You will receive standard recommendations for physical activity and general care.
At the end of the study, a final consultation will be conducted to assess differences between the two groups in functional capacity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation group (treatment group) | Experimental | Other: Cardiac rehabilitation program3 months of a cardiac rehabilitation program, in which patients will attend in person twice weekly (Mondays and Wednesdays or Tuesdays and Thursdays), in groups of up to 8 patients, for 1-hour exercise sessions including aerobic, resistance, respiratory, and balance/proprioceptive components. Sessions will be monitored and supervised by cardiologists, rehabilitation physicians, and physiotherapists. In addition, patients will attend one weekly in-person educational session throughout the 3-month program. |
| No intervention group | No intervention | –General exercise and educational recommendations |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients hospitalized for acute heart failure in a stable phase (on a stable dose or tapering intravenous diuretics for at least 48 hours, without intravenous inotropes or vasodilators for >72 hours).
- Baseline functional class II-III
- Age ≥ 65 years
- Able to walk >4 meters
- Any range of left ventricular ejection fraction
Key exclusion criteria (6 listed)
- Moderate to severe dementia
- Cardiac or other disease with a life expectancy <12 months
- Institutionalized patients or unable to travel to the rehabilitation center
- Functional class I or IV
- Uncontrolled arrhythmias
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 |
|---|---|---|
| Cardiac rehabilitation programCardiac rehabilitation program, in which patients will attend in person twice weekly (Mondays and Wednesdays or Tuesdays and Thursdays), in groups of up to 8 patients, for 1-hour exercise sessions including aerobic, resistance, respiratory, and balance/proprioceptive components. Sessions will be monitored and supervised by cardiologists, rehabilitation physicians, and physiotherapists. In addition, patients will attend one weekly in-person educational session throughout the 3-month program. | Other | Cardiac rehabilitation group (treatment group) |
Primary outcome
Primary Endpoint: Change in Peak Oxygen Uptake
Time frame: 3 months
Change in peak oxygen uptake measured by treadmill cardiopulmonary exercise testing (peak VO₂, measured in ml/kg/min).
14 secondary outcomes
Change in Functional Permormance assessed by the Short Physical Performance Battery (SPPB) score
Time frame: 3 months
Change in the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) score
Time frame: 3 and 6 months
Change in distance walked (meters) in the 6-Minute Walk Test (6MWT).
Time frame: 3 and 6 months
Change in caregiver burden assessed by the Zarit scale
Time frame: 3 and 6 months
Change in body composition parameters assessed by bioelectrical impedance analysis (BIA)
Time frame: 3 and 6 months
Number of participants experiencing all-cause mortality, heart failure decompensation, or heart failure-related hospitalization during follow-up
Time frame: 3 and 6 months
Change in Frailty status assessed by FRAIL scale
Time frame: 3 and 6 months
Change in emotional status assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 and 6 months
Change in Nutritional Status assessed using the Mini Nutritional Assessment (MNA) score
Time frame: 3 and 6 months
Change in Maximal Inspiratory Pressure (MIP)
Time frame: 3 and 6 months
Patient satisfaction
Time frame: 6 months
Patient adherence
Time frame: 3 months
Change in basic functional independence assessed by the Barthel Index
Time frame: 3 and 6 months
Change in maximal expiratory pressure (MEP)
Time frame: 3 ad 6 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 20 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Margarita Calvo-LOpez, MD principal investigator
Hospital Universitario Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation program in people with Heart Failure, run by Puerta de Hierro University Hospital at 1 site 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 5 inclusion and 6 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 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Margarita Calvo-Lopez, MD (+34637090285, margarita.calvo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint: Change in Peak Oxygen Uptake (time frame: 3 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 20 Jan 2026.