Heart Failure With Preserved Ejection Fraction (HFpEF)TRAIN-SARCNCT06655532
Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life
A study testing Exercise Program in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Sarcopenia, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF), Sarcopenia, Women
- What is being tested?
- Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 4 Nov 2024to 30 Jan 2026
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL, inthe last month.
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.
- Age ≥ 60 years old.
- The participant is willing to give informed consent to participate in the study.
- SARC-F score ≥4 points.
Who cannot join
- Inability to perform a valid baseline cardiopulmonary exercise test.
- Cardiac pacemaker.
- Significant primary moderate-to-severe valve disease.
- Effort angina or signs of ischemia during CPET.
- Primary cardiomyopathies.
- Cardiac transplantation.
- Any other comorbidity with a life expectancy of less than one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Concurrent Training-based Exercise Program in Women Over 60 Years With Heart Failure With Preserved Ejection Fraction and Sarcopenia on Functional Capacity, Quality of Life and Cognitive Function
This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.
After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL/kg/min (SD±2)] of 40 patients (20 per arm) would be necessary to test our hypothesis.
Read the detailed description
Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Sarcopenia, a prevalent concurrent condition, appears to be associated with reduced muscle strength and reduced maximal functional capacity.
Supervised training programs in patients with heart failure with reduced ejection fraction and sarcopenia have improved functional capacity. However, the researchers do not have evidence about the effects of a supervised training program on patients with HFpEF and sarcopenia, mainly when affecting women older than 60. This work aims to evaluate the effect of a 12-week supervised exercise program in patients with HFpEF and sarcopenia on maximal functional capacity evaluated by peak oxygen consumption (peakVO2).
- Being tested
- Exercise Program, Usual Care
- Keywords
- Heart Failure with Preserved Ejection Fraction, Sarcopenia, Cardiovascular Diseases, Heart Diseases, Heart Failure, Women
- Medical subject headings
- Sarcopenia, Cardiovascular Diseases, Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly.
Usual CareBehavioural
Patients allocated to this arm will receive standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. They will also receive a weekly phone call and an in-person monthly visit to monitor exercise training performance.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Sham comparator | Patients allocated to this arm will receive the standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. Receives: Behavioral: Usual Care |
| Supervised aerobic plus moderate to high-intensity strenght training | Active comparator | Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training. Receives: Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption
Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was 1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
Measured: Primary outcome: Peak oxygen consumption will be evaluated at first visit and after 12 weeks. We will evaluate peak oxygen consumption change from baseline.
Secondary outcomes (2)
Sarcopenia
SARC-F (strength, assistance in walking, rise from a chair, climb stairs, and falls) it is a self-administered questionnaire that has five components: strength, assistance with walking, getting up from a chair, climbing stairs, and falls. It has a 3-level scoring system based on the level of difficulty, ranging from 0 (none) to 2 (very much), for each component.
Measured: Sarcopenia: SARC Questionnaire will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Sarc-F Questionnaire change from baseline.
Kansas City Cardiomyopathy Questionnaire Scales
The Kansas City Cardiomyopathy Questionnaire includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy (the patient understanding of how to manage their heart failure). All Kansas City cardiomyopathy Questionnaire domains are scaled from 0 to 100, where scores represent health status as follows: 0 to 24, very poor to poor; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to excellent. A change of 5 points is considered to be a small but clinically important change, whereas changes of 10 and 20 points are considered moderate-to-large and large-to-very-large clinical changes.
Measured: The Kansas City Cardiomyopathy Questionnaire will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start4 Nov 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies 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
- Model description
- This is a prospective study, blinded for the evaluator, 2 randomized groups (1:1) to receive standard management alone or combined with a program of training that will be carried out in a single centre.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura López Bueno, PhD, Principal investigator, Instituto de Investigacion Sanitaria INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655532
- Sponsor's protocol ID
- TRAIN-SARC
- Acronym
- TRAIN-SARC
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Concurrent Training-based Exercise Program in Women Over 60 Years With Heart Failure With Preserved Ejection Fraction and Sarcopenia on Functional Capacity, Quality of Life and Cognitive Function
- ClinicalTrials.gov ID
- NCT06655532
- Acronym / sponsor ID
- TRAIN-SARC / TRAIN-SARC
- Keywords
- Heart Failure with Preserved Ejection Fraction, Sarcopenia, Cardiovascular Diseases, Heart Diseases, Heart Failure, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 23 Oct 2024 (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.
This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.
After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL/kg/min (SD±2)] of 40 patients (20 per arm) would be necessary to test our hypothesis.
Detailed description
Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Sarcopenia, a prevalent concurrent condition, appears to be associated with reduced muscle strength and reduced maximal functional capacity.
Supervised training programs in patients with heart failure with reduced ejection fraction and sarcopenia have improved functional capacity. However, the researchers do not have evidence about the effects of a supervised training program on patients with HFpEF and sarcopenia, mainly when affecting women older than 60. This work aims to evaluate the effect of a 12-week supervised exercise program in patients with HFpEF and sarcopenia on maximal functional capacity evaluated by peak oxygen consumption (peakVO2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a prospective study, blinded for the evaluator, 2 randomized groups (1:1) to receive standard management alone or combined with a program of training that will be carried out in a single centre.
| Arm | Type | Receives |
|---|---|---|
| Usual care | Sham comparator | Behavioral: Usual CarePatients allocated to this arm will receive the standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. |
| Supervised aerobic plus moderate to high-intensity strenght training | Active comparator | Behavioral: Exercise ProgramPatients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL, inthe last month.
- Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.
- Age ≥ 60 years old.
- The participant is willing to give informed consent to participate in the study.
- SARC-F score ≥4 points.
Key exclusion criteria (7 listed)
- Inability to perform a valid baseline cardiopulmonary exercise test.
- Cardiac pacemaker.
- Significant primary moderate-to-severe valve disease.
- Effort angina or signs of ischemia during CPET.
- Primary cardiomyopathies.
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 |
|---|---|---|
| Exercise ProgramPatients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly. | Behavioural | Supervised aerobic plus moderate to high-intensity strenght training |
| Usual CarePatients allocated to this arm will receive standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. They will also receive a weekly phone call and an in-person monthly visit to monitor exercise training performance. | Behavioural | Usual care |
Primary outcome
Peak oxygen consumption
Time frame: Primary outcome: Peak oxygen consumption will be evaluated at first visit and after 12 weeks. We will evaluate peak oxygen consumption change from baseline.
Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was 1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
2 secondary outcomes
Sarcopenia
Time frame: Sarcopenia: SARC Questionnaire will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Sarc-F Questionnaire change from baseline.
Kansas City Cardiomyopathy Questionnaire Scales
Time frame: The Kansas City Cardiomyopathy Questionnaire will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Heart Failure With Preserved Ejection Fraction (HFpEF)
Not yet recruitingPhase 2
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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
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ELEVATE-HFpEF Clinical Study
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The Clinical Trial of Tamibarotene for Patients With HFpEF (RELIEF Trial)
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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.
Laura López Bueno, PhD principal investigator
Instituto de Investigacion Sanitaria INCLIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Sarcopenia, run by Fundación para la Investigación del Hospital Clínico de Valencia 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 7 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura López Bueno (650682744, Laura.Lopez@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (time frame: Primary outcome: Peak oxygen consumption will be evaluated at first visit and after 12 weeks. We will evaluate peak oxygen consumption change from baseline.). 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 26 Oct 2024.