Heart FailureExIC-FEpNCT05726474
Comparison of the Effect of Two Types of Physical Exercises in Patients With Heart Failure With Preserved Ejection Fraction
A study testing Combined exercise and High interval training in people with Heart Failure and Physical Exercise, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Background: Heart failure (HF) is a chronic disease with a very important and increasingly severe social and health impact with a prevalence of 6.8% in Spain. HF with preserved ejection fraction (HFpEF) represents approximately 50% of all patients with HF. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure, Physical Exercise, Exercise Capacity
- What is being tested?
- Combined exercise and High interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSpain
- Study dates
- 23 Jan 2023to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart Failure with preserved ejection fraction picture (diagnosis according to ESC 2021 criteria)
- Signs and symptoms of Heart Failure
- A left ventricular ejection fraction of ≥50%.
- Objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of left ventricular diastolic dysfunction/elevated left ventricular filling pressures, including elevated natriuretic peptides.
- Sedentary men and women (structured exercise <2 x 30 min/week).
- Age ≥40 years
Show all 9Show fewer
- Written informed consent
- Clinically stable for 6 weeks
- Optimal medical treatment for ≥6 weeks
Who cannot join
- Non-cardiac causes of heart failure symptoms:
- Significant valvular or coronary artery disease - Uncontrolled hypertension or arrhythmias.
- Primary cardiomyopathies
- Significant pulmonary disease (FEV1<50% predicted, GOLD III-IV)
- Inability to exercise or conditions that may interfere with exercise intervention.
- Myocardial infarction in the last 3 months
- Signs of ischaemia during maximal cardiopulmonary exercise test.
- Comorbidity that may influence one-year prognosis 7. Participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Two Types of Physical Exercise on the Improvement of Exercise Capacity, Diastolic Function, Endothelial Function, and Arterial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction (ExIC-FEp Study)
Background: Heart failure (HF) is a chronic disease with a very important and increasingly severe social and health impact with a prevalence of 6.8% in Spain. HF with preserved ejection fraction (HFpEF) represents approximately 50% of all patients with HF. In the absence of pharmacological treatments that have succeeded in reducing mortality or morbidity in this pathology, it is recommended that interventions be directed at prevention, symptomatic treatment of HF and treatment of comorbidities to avoid exacerbations, thus physical exercise is recognized as an important adjunct in the treatment of HF and is recommended by the guidelines of the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC). Currently, aerobic exercise is the most studied physical exercise in this population, but in recent years high-intensity interval training (HIIT) and the combination of aerobic exercise with strength training (combined exercise) have emerged.
Objectives: The overall objective of this study is to compare the effectiveness of combined training and HIIT on exercise capacity, diastolic function, endothelial function, and arterial stiffness in patients with HFpEF. The specific objectives of this study are: a) to compare the effectiveness of combined training and HIIT on quality of life in patients with HFpEF and b) to analyze the cost-effectiveness of combined training and HIIT versus conventional treatment in patients with HFpEF.
Read more
Methodology: The ExIC-FEp study will be a single-blind randomized clinical trial with 3 arms (combined exercise, HIIT and a control group), conducted at the Health and Social Research Center of the University of Castilla-La Mancha, to analyze two types of supervised physical exercise in patients with HFpEF for 6 months. Patients with HFpEF will be randomly assigned (1:1:1) to the combined exercise, HIIT or control group. All participants will be examined, at baseline (prior to randomization), at three months (mid-intervention) and at six months (at the end of the intervention). Participants will undergo physical examination, echocardiography, maximal cardiopulmonary stress test, and measurement of endothelial function and arterial stiffness. In addition, sociodemographic variables, quality of life, physical activity, adherence to the Mediterranean diet, strength, spirometry and blood sampling will be measured.
Expected scientific contributions: this randomized clinical trial will represent a a significant advance in the scientific evidence available on the efficacy of physical exercise in the treatment of HFpEF, through: (a) transfer of the results to physicians, nurses and patients; (b) dissemination of results through scientific articles, doctoral theses and participation in congresses; (c) press releases and press conferences with the aim of disseminating the research results to the population; (d) dissemination through social networks to improve the social impact; and (e) design and content development of a web page.
- Conditions
- Heart Failure, Physical Exercise, Exercise Capacity, Diastolic Function, Endothelial Function, Arterial Stiffness
- Being tested
- Combined exercise, High interval training
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined exerciseBehavioural
Patients will exercise for 40 minutes three times a week on an ergometric bicycle at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without ergometer at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without shortness of breathing difficulty. In addition, strength training will be performed (bench press, leg press, leg curl, leg machine, bench press, leg press, leg curl, leg curl, leg machine). leg curls, leg curls, rowing machine, triceps dips, pectoral pull-ups) twice a week. week. Strength training will be performed with 15 repetitions per exercise and per session, with a corresponding workload of 15 repetitions. session, with a workload corresponding to 60% to 65% of the 1-repetition maximum (1RM) measured at (1RM) measured at the beginning and at the end of the intervention.
High interval trainingBehavioural
Patients will perform three training sessions per week. Each training session begins with a 10-minute warm-up at moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, no shortness of breath) before cycling, four 4-minute intervals at high intensity (corresponding to 85-90% of VO2max, 90-95% of HRmax, 15-17 on the Borg scale, shortness of breath). Each interval will be separated by 3 minutes of active pauses, with a HRmax of 50-70%. The training session will end with 3 minutes of cool down at moderate intensity (corresponding to 50-60%). moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without difficulty). Borg scale, no shortness of breath). The total exercise time will be 40 minutes for the HIIT group.
| Study group | Role | What they receive |
|---|---|---|
| Combined exercise | Experimental | Not described Receives: Behavioral: Combined exercise |
| High interval training | Experimental | Not described Receives: Behavioral: High interval training |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity
Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.
Measured: Change from Baseline exercise capacity at 3 months
E velocity
E velocity in m/s
Measured: Change from Baseline E velocity at 3 months
Endothelial function
Carotid intima-media thickness: by ultrasound with the Sonosite SII device.
Measured: Change from Baseline endothelial function at 3 months
Arterial stiffness
Pulse wave velocity and augmentation index
Measured: Change from Baseline arterial stiffness at 3 months
A velocity
A velocity in m/s
Measured: Change from Baseline A velocity at 3 months
E/A ratio
E/A ratio
Measured: Change from Baseline E/A ratio at 3 months
e' velocity
e' velocity in m/s
Measured: Change from Baseline e' velocity in m/s at 3 months
E/e' ratio
E/e' ratio
Measured: Change from Baseline E/e' ratio at 3 months
ejection fraction
percentage of ejection fraction
Measured: Change from Baseline ejection fraction at 3 months
left ventricular volume index
left ventricular volume index
Measured: Change from Baseline left ventricular volume index at 3 months
end-diastolic volume
end-diastolic volume
Measured: Change from Baseline end-diastolic volume at 3 months
left ventricular mass
left ventricular mass
Measured: Change from Baseline left ventricular mass at 3 months
left atrial diameter
left atrial diameter
Measured: Change from Baseline left atrial diameter at 3 months
isovolume relaxation time
isovolume relaxation time in seg
Measured: Change from Baseline isovolume relaxation time at 3 months
deceleration time
deceleration time in m/s
Measured: Change from Baseline deceleration time at 3 months
left atrial volume index
left atrial volume index
Measured: Change from Baseline left atrial volume index at 3 months
Secondary outcomes (23)
Sociodemographic variables
Age, sex and socioeconomic level
Measured: Baseline
Patient's medical history
Comorbidities and medication
Measured: Baseline
Weight
Weight in kilogram
Measured: Change from Baseline weight at 3 months
Muscular strength
Handgrip force to be determined with TKK 5401 Grip-D dynamometer.
Measured: Change from Baseline Muscular strength at 3 months
Spirometry
Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1) and FEV1/FVC ratio.
Measured: Change from Baseline spirometry at 3 months
Glucose
Glucose
Measured: Change from Baseline Glucose at 3 months
Physical activity
Accelerometry. Time of physical activity
Measured: Change from Baseline phisical activity at 3 months
HQoL
Validated 12-item health questionnaire (SF-12). From 0 to 12 (higher values better HQoL)
Measured: Change from Baseline HQoL at 3 months
Adherence to the Mediterranean diet
Validated 14-item questionnaire on adherence to the Mediterranean diet (MEDAS-14). From 0 to 14 (higher values better Adherence)
Measured: Change from Baseline Adherence to the Mediterranean diet at 3 months
height
height in centimeters
Measured: Change from Baseline height at 3 months
BMI
BMI in kg/m2
Measured: Change from Baseline BMI at 3 months
waist circumference
waist circumference in cm
Measured: Change from Baseline waist circumference at 3 months
body fat
percentage of body fat
Measured: Change from Baseline body fat at 3 months
blood pressure
systolic and diastolic blood pressure in mmHg
Measured: Change from Baseline blood pressure at 3 months
total cholesterol
total cholesterol
Measured: Change from Baseline total cholesterol at 6 months
triglycerides
triglycerides
Measured: Change from Baseline triglycerides at 6 months
HDL-cholesterol
HDL-cholesterol
Measured: Change from Baseline HDL-cholesterol at 6 months
LDL-cholesterol
LDL-cholesterol
Measured: Change from Baseline LDL-cholesterol at 6 months
apolipoproteins A1 and B
apolipoproteins A1 and B
Measured: Change from Baseline apolipoproteins A1 and B at 6 months
insulin
insulin
Measured: Change from Baseline insulin at 6 months
ultra-sensitive C-reactive protein
ultra-sensitive C-reactive protein
Measured: Change from Baseline ultra-sensitive C-reactive protein at 6 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Measured: Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months
HbA1c
HbA1c
Measured: Change from Baseline HbA1c at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start23 Jan 2023
- Primary completion30 Sep 2024
- Study completion15 May 2025
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 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726474
- Sponsor's protocol ID
- SBPLY/21/180501/000112
- Acronym
- ExIC-FEp
- Status last verified
- May 2025
- First submitted
- 20 Oct 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cavero-Redondo I, Saz-Lara A, Bizzozero-Peroni B, Nunez-Martinez L, Diaz-Goni V, Calero-Paniagua I, Matinez-Garcia I, Pascual-Morena C. Accuracy of the 6-Minute Walk Test for Assessing Functional Capacity in Patients With Heart Failure With Preserved Ejection Fraction and Other Chronic Cardiac Pathologies: Results of the ExIC-FEp Trial and a Meta-Analysis. Sports Med Open. 2024 Jun 18;10(1):74. doi: 10.1186/s40798-024-00740-6.
PubMed 38886304
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Two Types of Physical Exercise on the Improvement of Exercise Capacity, Diastolic Function, Endothelial Function, and Arterial Stiffness in Patients With Heart Failure With Preserved Ejection Fraction (ExIC-FEp Study)
- ClinicalTrials.gov ID
- NCT05726474
- Acronym / sponsor ID
- ExIC-FEp / SBPLY/21/180501/000112
- Conditions
- Heart Failure, Physical Exercise, Exercise Capacity, Diastolic Function, Endothelial Function, Arterial Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 14 Feb 2023 (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.
Background: Heart failure (HF) is a chronic disease with a very important and increasingly severe social and health impact with a prevalence of 6.8% in Spain. HF with preserved ejection fraction (HFpEF) represents approximately 50% of all patients with HF. In the absence of pharmacological treatments that have succeeded in reducing mortality or morbidity in this pathology, it is recommended that interventions be directed at prevention, symptomatic treatment of HF and treatment of comorbidities to avoid exacerbations, thus physical exercise is recognized as an important adjunct in the treatment of HF and is recommended by the guidelines of the American College of Cardiology (ACC)/American Heart Association (AHA) and the European Society of Cardiology (ESC). Currently, aerobic exercise is the most studied physical exercise in this population, but in recent years high-intensity interval training (HIIT) and the combination of aerobic exercise with strength training (combined exercise) have emerged.
Objectives: The overall objective of this study is to compare the effectiveness of combined training and HIIT on exercise capacity, diastolic function, endothelial function, and arterial stiffness in patients with HFpEF. The specific objectives of this study are: a) to compare the effectiveness of combined training and HIIT on quality of life in patients with HFpEF and b) to analyze the cost-effectiveness of combined training and HIIT versus conventional treatment in patients with HFpEF.
Methodology: The ExIC-FEp study will be a single-blind randomized clinical trial with 3 arms (combined exercise, HIIT and a control group), conducted at the Health and Social Research Center of the University of Castilla-La Mancha, to analyze two types of supervised physical exercise in patients with HFpEF for 6 months. Patients with HFpEF will be randomly assigned (1:1:1) to the combined exercise, HIIT or control group. All participants will be examined, at baseline (prior to randomization), at three months (mid-intervention) and at six months (at the end of the intervention). Participants will undergo physical examination, echocardiography, maximal cardiopulmonary stress test, and measurement of endothelial function and arterial stiffness. In addition, sociodemographic variables, quality of life, physical activity, adherence to the Mediterranean diet, strength, spirometry and blood sampling will be measured.
Expected scientific contributions: this randomized clinical trial will represent a a significant advance in the scientific evidence available on the efficacy of physical exercise in the treatment of HFpEF, through: (a) transfer of the results to physicians, nurses and patients; (b) dissemination of results through scientific articles, doctoral theses and participation in congresses; (c) press releases and press conferences with the aim of disseminating the research results to the population; (d) dissemination through social networks to improve the social impact; and (e) design and content development of a web page.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combined exercise | Experimental | Behavioral: Combined exercise |
| High interval training | Experimental | Behavioral: High interval training |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Heart Failure with preserved ejection fraction picture (diagnosis according to ESC 2021 criteria)
- Sedentary men and women (structured exercise <2 x 30 min/week).
- Age ≥40 years
- Written informed consent
- Clinically stable for 6 weeks
Key exclusion criteria (8 listed)
- Non-cardiac causes of heart failure symptoms:
- Significant pulmonary disease (FEV1<50% predicted, GOLD III-IV)
- Inability to exercise or conditions that may interfere with exercise intervention.
- Myocardial infarction in the last 3 months
- Signs of ischaemia during maximal cardiopulmonary exercise test.
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 |
|---|---|---|
| Combined exercisePatients will exercise for 40 minutes three times a week on an ergometric bicycle at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without ergometer at 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without shortness of breathing difficulty. In addition, strength training will be performed (bench press, leg press, leg curl, leg machine, bench press, leg press, leg curl, leg curl, leg machine). leg curls, leg curls, rowing machine, triceps dips, pectoral pull-ups) twice a week. week. Strength training will be performed with 15 repetitions per exercise and per session, with a corresponding workload of 15 repetitions. session, with a workload corresponding to 60% to 65% of the 1-repetition maximum (1RM) measured at (1RM) measured at the beginning and at the end of the intervention. | Behavioural | Combined exercise |
| High interval trainingPatients will perform three training sessions per week. Each training session begins with a 10-minute warm-up at moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, no shortness of breath) before cycling, four 4-minute intervals at high intensity (corresponding to 85-90% of VO2max, 90-95% of HRmax, 15-17 on the Borg scale, shortness of breath). Each interval will be separated by 3 minutes of active pauses, with a HRmax of 50-70%. The training session will end with 3 minutes of cool down at moderate intensity (corresponding to 50-60%). moderate intensity (corresponding to 50-60% of VO2max, 60-70% of HRmax, 11-13 on the Borg scale, without difficulty). Borg scale, no shortness of breath). The total exercise time will be 40 minutes for the HIIT group. | Behavioural | High interval training |
Primary outcome
Exercise capacity
Time frame: Change from Baseline exercise capacity at 3 months
Maximal cardiopulmonary stress test with Ergoline600 ergometer bicycle.
E velocity
Time frame: Change from Baseline E velocity at 3 months
E velocity in m/s
Endothelial function
Time frame: Change from Baseline endothelial function at 3 months
Carotid intima-media thickness: by ultrasound with the Sonosite SII device.
Arterial stiffness
Time frame: Change from Baseline arterial stiffness at 3 months
Pulse wave velocity and augmentation index
A velocity
Time frame: Change from Baseline A velocity at 3 months
A velocity in m/s
E/A ratio
Time frame: Change from Baseline E/A ratio at 3 months
E/A ratio
e' velocity
Time frame: Change from Baseline e' velocity in m/s at 3 months
e' velocity in m/s
E/e' ratio
Time frame: Change from Baseline E/e' ratio at 3 months
E/e' ratio
ejection fraction
Time frame: Change from Baseline ejection fraction at 3 months
percentage of ejection fraction
left ventricular volume index
Time frame: Change from Baseline left ventricular volume index at 3 months
left ventricular volume index
end-diastolic volume
Time frame: Change from Baseline end-diastolic volume at 3 months
end-diastolic volume
left ventricular mass
Time frame: Change from Baseline left ventricular mass at 3 months
left ventricular mass
left atrial diameter
Time frame: Change from Baseline left atrial diameter at 3 months
left atrial diameter
isovolume relaxation time
Time frame: Change from Baseline isovolume relaxation time at 3 months
isovolume relaxation time in seg
deceleration time
Time frame: Change from Baseline deceleration time at 3 months
deceleration time in m/s
left atrial volume index
Time frame: Change from Baseline left atrial volume index at 3 months
left atrial volume index
23 secondary outcomes
Sociodemographic variables
Time frame: Baseline
Patient's medical history
Time frame: Baseline
Weight
Time frame: Change from Baseline weight at 3 months
Muscular strength
Time frame: Change from Baseline Muscular strength at 3 months
Spirometry
Time frame: Change from Baseline spirometry at 3 months
Glucose
Time frame: Change from Baseline Glucose at 3 months
Physical activity
Time frame: Change from Baseline phisical activity at 3 months
HQoL
Time frame: Change from Baseline HQoL at 3 months
Adherence to the Mediterranean diet
Time frame: Change from Baseline Adherence to the Mediterranean diet at 3 months
height
Time frame: Change from Baseline height at 3 months
BMI
Time frame: Change from Baseline BMI at 3 months
waist circumference
Time frame: Change from Baseline waist circumference at 3 months
body fat
Time frame: Change from Baseline body fat at 3 months
blood pressure
Time frame: Change from Baseline blood pressure at 3 months
total cholesterol
Time frame: Change from Baseline total cholesterol at 6 months
triglycerides
Time frame: Change from Baseline triglycerides at 6 months
HDL-cholesterol
Time frame: Change from Baseline HDL-cholesterol at 6 months
LDL-cholesterol
Time frame: Change from Baseline LDL-cholesterol at 6 months
apolipoproteins A1 and B
Time frame: Change from Baseline apolipoproteins A1 and B at 6 months
insulin
Time frame: Change from Baseline insulin at 6 months
ultra-sensitive C-reactive protein
Time frame: Change from Baseline ultra-sensitive C-reactive protein at 6 months
N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Time frame: Change from Baseline N-terminal pro-B-type natriuretic peptide (NT-proBNP) at 6 months
HbA1c
Time frame: Change from Baseline HbA1c at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 38886304Cavero-Redondo I, Saz-Lara A, Bizzozero-Peroni B, Nunez-Martinez L, Diaz-Goni V, Calero-Paniagua I, Matinez-Garcia I, Pascual-Morena C. Accuracy of the 6-Minute Walk Test for Assessing Functional Capacity in Patients With Heart Failure With Preserved Ejection Fraction and Other Chronic Cardiac Pathologies: Results of the ExIC-FEp Trial and a Meta-Analysis. Sports Med Open. 2024 Jun 18;10(1):74. doi: 10.1186/s40798-024-00740-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined exercise and High interval training in people with Heart Failure and Physical Exercise, run by University of Castilla-La Mancha 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 4 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Exercise capacity (time frame: Change from Baseline exercise capacity at 3 months). The study lists 16 primary outcomes in all. 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 NCT05726474, 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 4 Jun 2025.