Home-based personalized exercise rehab for cardiorenal syndrome in HFrEF patients
Efficacy and Safety of Home-Based Exercise Rehabilitation in Patients With Cardiorenal Syndrome Complicated by Chronic Heart Failure With Reduced Ejection Fraction (HFrEF): A Randomized Controlled Trial
This will test whether adding a personalized, home-based exercise program to standard heart-failure medications helps adults (18–75) with HFrEF and chronic kidney dysfunction (cardiorenal syndrome).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Drugs / interventions | cart |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT07167368 on ClinicalTrials.gov |
What this trial studies
This randomized, interventional trial will enroll 60 adults with chronic HFrEF and renal insufficiency and assign them 1:1 to standard drug therapy alone or standard therapy plus a tailored, home-based exercise rehabilitation program for 6 months. Exercise prescriptions are individualized using a two-step assessment protocol to set safe intensity and monitor tolerance, with periodic clinic visits for baseline and follow-up testing. Key functional outcomes include peak oxygen uptake (VO2 peak) and 6-minute walk distance, and safety monitoring will track arrhythmias, renal function, and other adverse events. The home-based model is chosen to improve long-term adherence and reduce barriers such as transportation while allowing personalized intensity adjustments for patients with dual organ dysfunction.
Who should consider this trial
Good fit: Adults aged 18–75 with chronically stable HFrEF (NYHA II–III), eGFR < 90 mL/min/1.73 m², and low exercise risk who can comply with home training and clinic visits.
Not a fit: Patients with uncontrolled hypertension, severe arrhythmias, significant valvular disease, severe pulmonary disease, major musculoskeletal limitations, or other listed exclusions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding home-based exercise could improve exercise capacity, functional status, and possibly cardiac and renal outcomes for patients with CRS and HFrEF.
How similar studies have performed: Exercise rehabilitation has improved cardiac function and exercise capacity in uncomplicated chronic heart failure, but its effects specifically in cardiorenal syndrome remain largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronically stable HFrEF complicated by kidney dysfunction (eGFR \< 90 mL/min/1.73m²) * NYHA class II-III * Low risk in exercise risk assessment * Aged 18-75 years Exclusion Criteria: * Uncontrolled hypertension * Severe arrhythmias (including frequent ventricular premature contractions, ventricular tachycardia, rapid atrial fibrillation, sick sinus syndrome, and second-degree or higher atrioventricular block) * Obstructive hypertrophic cardiomyopathy * Moderate to severe stenotic valvular heart disease * Deep vein thrombosis or pulmonary embolism * History of syncope * Severe anemia * Abnormal thyroid function * Severe pulmonary diseases * Mental illnesses * Osteoarticular or muscular diseases that impede rehabilitation training
Where this trial is running
Nantong, Jiangsu
- The Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.