High-intensity aerobic and strength exercise for adults with chronic kidney disease on dialysis or conservative care
Effect of Exercise in Patients With Chronic Kidney Disease: TONE Trial
NA · Casa di Cura Dott. Pederzoli · NCT07438002
This study tests whether a combined high-intensity aerobic and strength training program improves fitness and health in adults with chronic kidney disease who are on dialysis or receiving conservative treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Casa di Cura Dott. Pederzoli (other) |
| Locations | 1 site (Peschiera del Garda, Verona) |
| Trial ID | NCT07438002 on ClinicalTrials.gov |
What this trial studies
Adults with CKD (stages 1–5) who are either under conservative care or on chronic hemodialysis for at least three months will be randomized to a combined high-intensity aerobic plus resistance training program or to a control group receiving usual care. The intervention involves supervised high-intensity aerobic and strength sessions, while the control group continues standard management without the exercise program. Participants undergo a cardiopulmonary exercise test for safety screening, and those with severe cardiovascular disease, recent ischemic events, or anatomical limitations are excluded. The trial is run at a single private clinic in Peschiera del Garda, Verona, Italy.
Who should consider this trial
Good fit: Adults (age ≥18) with CKD stage 1–5 who are either on conservative treatment or have been on chronic hemodialysis for at least three months and who can safely perform high-intensity exercise and provide informed consent.
Not a fit: Patients with severe cardiovascular disease (NYHA class IV or uncontrolled class III hypertension), recent TIA or myocardial ischemia, anatomical limitations, or who fail the exercise stress test are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could improve physical fitness, muscle strength, and quality of life for people living with CKD.
How similar studies have performed: Previous aerobic and resistance exercise studies in CKD and dialysis populations have shown improvements in fitness, strength, and quality of life, though combined high-intensity programs are less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signature of the informed consent * Patients with CKD stage 1 to 5 under conservative treatment * Patients undergoing chronic hemodialysis for at least 3 months * Age ≥ 18 Exclusion Criteria: * Severe cardiovascular disease (NYHA class IV or hypertension class III) * TIA or myocardial ischemia within the last three months * Anatomical limitations * Health conditions detected during the stress test (CPET)
Where this trial is running
Peschiera del Garda, Verona
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda, Verona, Italy (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.
Conditions: Chronic Kidney Disease, Nephrology, exercise, physical activity