Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment
TONE
Effect of Exercise in Patients With Chronic Kidney Disease: TONE Trial
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2025
CompletedFirst Submitted
Initial submission to the registry
February 13, 2026
CompletedFirst Posted
Study publicly available on registry
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 27, 2026
February 1, 2026
12 months
February 13, 2026
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Gait speed (6MWT)
• 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)
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 Outcomes (6)
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
- +1 more secondary outcomes
Other Outcomes (2)
effect of physical activity on mitochondrial activity
through study completion, an average of 1 year
Effect of physical activity on mitochondrial activity
through study completion, an average of 1 year
Study Arms (2)
combined exercise
EXPERIMENTALparticipants will undergo a combined endurance and resistance exercise training
control group
ACTIVE COMPARATORparticipants performs outcome measures sessions only, including blood sample collection.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2026
First Posted
February 27, 2026
Study Start
September 2, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share