Effectiveness of a Cardiac Rehabilitation Program on Biomechanical, Imaging, and Physiological Biomarkers in Elderly Patients With Heart Failure.
Cardiac rehab program tested for elderly heart failure patients.
Plain English Summary
Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure. is a Not Applicable clinical trial sponsored by University of Malaga studying Heart Failure With Preserved Ejection Fraction, Sarcopenia, Frail Elderly Syndrome, Comorbidities and Coexisting Conditions. This study tests if a 12-week cardiac rehabilitation program improves physical function, heart health, and overall well-being in older adults with heart failure. It is for elderly patients (70+) diagnosed with a specific type of heart failure (preserved ejection fraction) who are clinically stable. Participants will engage in supervised exercise sessions (strength and aerobic) or attend educational sessions, with regular assessments over 6 months. Alternatives include standard medical care and lifestyle advice for heart failure management. The trial aims to enroll 65 participants.
Official Summary
The main objective of the study is to assess the effectiveness of a cardiac rehabilitation program on functionality, measured by kinematic analysis, cardiorespiratory capacity, and ventricular ejection fraction in elderly patients with heart failure (HF). Other objectives will be; 1) to validate the kinematic analysis as an objective functional assessment that allows performing a functional stratification based on the severity of impairment ("kinematic phenotypes"), as well as to identify those patients who responders or are not responders to the cardiac rehabilitation program; 2) to develop a functional index that includes objective functional parameters, biomechanical biomarkers (heart and musculoskeletal echography) and physiological biomarkers (maximum consumption of oxygen (VO2 max), maximum heart rate (HR max) and blood lactate levels; 3) to analyse the degree of concordance of biomechanical biomarkers with functional tests normally used in clinical practice and with imaging and physiological biomarkers. A randomized, controlled, crossover clinical trial will be carried out at the Hospital Regional Universitario de Málaga. Clinically stable HF patients ≥70 years old will be included. The cardiac rehabilitation program will last 12 weeks and will follow the recommendations of the European Association of Cardiovascular Prevention and Rehabilitation. The patients will perform different functional tests, which will be at baseline, at 3 months and 6 months of follow-up.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are over 70, have been diagnosed with heart failure, are clinically stable, and are receiving optimal medical treatment. You cannot join if you have other serious heart problems (not heart failure), are in the most severe class of heart failure (NYHA class 4), have been hospitalized recently, or have significant cognitive impairment. You also cannot join if you have trouble getting out of a chair, cannot walk independently, or are already in another experimental treatment study. You must be able to provide informed consent. This trial is studying Heart Failure With Preserved Ejection Fraction, Sarcopenia, Frail Elderly Syndrome, Comorbidities and Coexisting Conditions, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well the cardiac rehabilitation program improves the amount of oxygen your body can use during exercise, which is a key indicator of heart and lung health. The specific primary outcome measures are: Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Baseline); Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Post intervention_difference (12 weeks after baseline)); Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Follow up (12 weeks after post-intervention)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial addresses a gap in managing elderly heart failure patients by evaluating a structured cardiac rehabilitation program to improve their physical function and quality of life. This research targets Heart Failure With Preserved Ejection Fraction, Sarcopenia, Frail Elderly Syndrome, Comorbidities and Coexisting Conditions, where improved treatment options are needed.
Investor Insight
This trial focuses on a growing patient population (elderly with heart failure) and aims to validate a non-pharmacological intervention, potentially leading to new guidelines for cardiac rehabilitatio
Is This Trial Right for Me?
Ask your doctor if this program is right for you, especially regarding your specific heart condition and overall health. Be prepared for regular exercise sessions (strength and aerobic) and functional tests over a 12-week period, with follow-up assessments. Understand that you will be randomly assigned to either the exercise program or an educational group. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: DOUBLE
- Enrollment: 65 participants
Interventions
- PROCEDURE: Cardiac Rehabilitation Program (CR) — Strength exercises: strengthe exercise will be performed twice a week for 12 weeks, 4-6 series at 60% RM at the beginning of the program, with a progression towards 85% RM in each functional movement at the end of the intervention. The patients will rest for 90 seconds between series and 3 minutes between exercises. Each session has an estimated duration of between 45-60 min. Aerobic exercise: aerobic exercise it will be performed twice a week for twelve weeks, between 45-60 min each session of
- BEHAVIORAL: Control Group (CG) — The control group will receive two education sessions per week for twelve weeks on the complications derived from Heart Failure (HF), functional deterioration, and healthy lifestyle habits.
Primary Outcomes
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Baseline)
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Post intervention_difference (12 weeks after baseline))
- Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Follow up (12 weeks after post-intervention))
Secondary Outcomes
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (PhA) (Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (R) (Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (Xc) (Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (FFM) (Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
- Physiological biomarkers _Bioelectrical Impedance Analysis (BIA)- (FM) (Baseline, Post-intervention (12 weeks after baseline) and Follow up (12 weeks after post-intervention))
Full Eligibility Criteria
Inclusion Criteria: * Subjects older than 70 years. * Subjects diagnosed with Heart Failure (HF) followed by the Heart Failure Unit. * Subjects will be able or filling out questionnaires and perform functional tasks; * Clinical stability. * Patients receive optimal treatment. Exclusion Criteria: * Participants with cardiac pathologies that do not have an HF situation * Score on the NYHA scale equal to 4. * Hospitalization in a period of time equal to or less than 3 months. * Score on the Mini-Mental scale (MMSE) below 24. * Inability to get up from the chair at least 5 times * Inability to walk. * Inability to walk independently without a gait assist device (cane, crutch, or walker). * Participation in an experimental study where they receive treatment. * Inability to provide informed consent.
Trial Locations
- Antonio Cuesta Vargas, Málaga, Spain
Frequently Asked Questions
What is clinical trial NCT05393362?
NCT05393362 is a Not Applicable INTERVENTIONAL study titled "Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure.." It is currently completed and is sponsored by University of Malaga. The trial targets enrollment of 65 participants.
What conditions does NCT05393362 study?
This trial investigates treatments for Heart Failure With Preserved Ejection Fraction, Sarcopenia, Frail Elderly Syndrome, Comorbidities and Coexisting Conditions. The primary condition under study is Heart Failure With Preserved Ejection Fraction.
What treatments are being tested in NCT05393362?
The interventions being studied include: Cardiac Rehabilitation Program (CR) (PROCEDURE), Control Group (CG) (BEHAVIORAL). Strength exercises: strengthe exercise will be performed twice a week for 12 weeks, 4-6 series at 60% RM at the beginning of the program, with a progression towards 85% RM in each functional movement at the end of the intervention. The patients will rest for 90 seconds between series and 3 minutes between exercises. Each session has an estimated duration of between 45-60 min. Aerobic exercise: aerobic exercise it will be performed twice a week for twelve weeks, between 45-60 min each session of
What does Not Applicable mean for NCT05393362?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05393362?
This trial is currently "Completed." It started on 2023-03-07. The estimated completion date is 2025-07-01.
Who is sponsoring NCT05393362?
NCT05393362 is sponsored by University of Malaga. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05393362?
The trial aims to enroll 65 participants. The trial status is completed.
How is NCT05393362 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT05393362?
The primary outcome measures are: Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Baseline); Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Post intervention_difference (12 weeks after baseline)); Physiological biomarkers_Cardiopulmonary Exercise Testing (CPET)-(Peak VO2) (Follow up (12 weeks after post-intervention)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05393362 being conducted?
This trial is being conducted at 1 site, including Málaga (Spain).
Where can I find official information about NCT05393362?
The official record for NCT05393362 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05393362. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05393362 testing in simple terms?
This study tests if a 12-week cardiac rehabilitation program improves physical function, heart health, and overall well-being in older adults with heart failure. It is for elderly patients (70+) diagnosed with a specific type of heart failure (preserved ejection fraction) who are clinically stable.
Why is this trial significant?
This trial addresses a gap in managing elderly heart failure patients by evaluating a structured cardiac rehabilitation program to improve their physical function and quality of life.
What are the potential risks of participating in NCT05393362?
Potential risks include muscle soreness, fatigue, or minor injuries from exercise, which will be monitored by trained staff. Some participants might experience discomfort during functional tests or have an initial worsening of symptoms before improvement. The control group receives education, which may not provide the same physical benefits as the exercise program. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05393362?
Ask your doctor if this program is right for you, especially regarding your specific heart condition and overall health. Be prepared for regular exercise sessions (strength and aerobic) and functional tests over a 12-week period, with follow-up assessments. Understand that you will be randomly assigned to either the exercise program or an educational group. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05393362 signal from an investment perspective?
This trial focuses on a growing patient population (elderly with heart failure) and aims to validate a non-pharmacological intervention, potentially leading to new guidelines for cardiac rehabilitatio This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will engage in supervised exercise sessions (strength and aerobic) or attend educational sessions, with regular assessments over 6 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Heart Failure With Preserved Ejection Fraction Trials
View all Heart Failure With Preserved Ejection Fraction clinical trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.