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

February 20, 2026 updated by: Casa di Cura Dott. Pederzoli

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Verona
      • Peschiera del Garda, Verona, Italy, 37019
        • Recruiting
        • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: combined exercise
participants will undergo a combined endurance and resistance exercise training
Other: Exercise
All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training
Active Comparator: control group
participants performs outcome measures sessions only, including blood sample collection.
Other: control
outcome measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed (6MWT)
Time Frame: 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
through study completion, an average of 1 year
Physical performance (SPPB)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Cardiopulmonary capacity (CPET)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Lower limbs strength (1-RM)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Maximum isometric strength of the upper limb (hand grip)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Daily physical activity amount (IPAQ)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Quality of life (SF36)
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of physical activity on mitochondrial activity
Time Frame: through study completion, an average of 1 year
Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, MOTS-c (mg)
through study completion, an average of 1 year
Effect of physical activity on mitochondrial activity
Time Frame: through study completion, an average of 1 year
Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, humanin (mg)
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa di Cura Dott. Pederzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 573CET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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