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Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment

Effect of Exercise in Patients With Chronic Kidney Disease: TONE Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07438002
Acronym
TONE
Enrollment
50
Registered
2026-02-27
Start date
2025-09-02
Completion date
2026-09-01
Last updated
2026-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Nephrology, exercise, physical activity

Brief summary

This study aims to analyze the effects of physical activity in patients with chronic kidney disease undergoing dialysis or conservative treatment. Patients will be randomized into two groups: combined exercise (high-intensity aerobic resistance + strength training) and control group

Interventions

OTHERExercise

All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training

OTHERcontrol

outcome measures

Sponsors

Casa di Cura Dott. Pederzoli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Gait speed (6MWT)through study completion, an average of 1 year• Assess the effect of exercise on physical performance and quality of life on pa-tients with chronic kidney disease from stage 1 to end stage renal disease on maintenance haemodialysis or on conservative treatment
Physical performance (SPPB)through study completion, an average of 1 year
Cardiopulmonary capacity (CPET)through study completion, an average of 1 year
Lower limbs strength (1-RM)through study completion, an average of 1 year
Maximum isometric strength of the upper limb (hand grip)through study completion, an average of 1 year
Daily physical activity amount (IPAQ)through study completion, an average of 1 year
Quality of life (SF36)through study completion, an average of 1 year

Secondary

MeasureTime frame
Nutritional status (24HR, FFQ)through study completion, an average of 1 year
Body composition (DEXA, BIVA)through study completion, an average of 1 year
Psychological and psychosocial conditions (BDI, MMSE)through study completion, an average of 1 year
Hemodynamic and vascular functions (SV, CO, HR, FBF, FMD, sPLM)through study completion, an average of 1 year
Muscular oxygen extraction (NIRS)through study completion, an average of 1 year
Neuromuscular functions (MCV, RFD)through study completion, an average of 1 year

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026