Chronic Kidney DiseaseTONENCT07438002
Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment
A study testing Exercise in people with Chronic Kidney Disease, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 2 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Verona, 37019
Yuri Battaglia, MD, +39 0456444193, urc@ospedalepederzoli.it
About this study
Official title: 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
- Conditions
- Chronic Kidney Disease
- Being tested
- Exercise, control
- Keywords
- Nephrology, exercise, physical activity
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training
controlOther
outcome measures
| Study group | Role | What they receive |
|---|---|---|
| combined exercise | Experimental | participants will undergo a combined endurance and resistance exercise training Receives: Other: Exercise |
| control group | Active comparator | participants performs outcome measures sessions only, including blood sample collection. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Physical performance (SPPB)
Measured: through study completion, an average of 1 year
Cardiopulmonary capacity (CPET)
Measured: through study completion, an average of 1 year
Lower limbs strength (1-RM)
Measured: through study completion, an average of 1 year
Maximum isometric strength of the upper limb (hand grip)
Measured: through study completion, an average of 1 year
Daily physical activity amount (IPAQ)
Measured: through study completion, an average of 1 year
Quality of life (SF36)
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Nutritional status (24HR, FFQ)
Measured: through study completion, an average of 1 year
Body composition (DEXA, BIVA)
Measured: through study completion, an average of 1 year
Psychological and psychosocial conditions (BDI, MMSE)
Measured: through study completion, an average of 1 year
Hemodynamic and vascular functions (SV, CO, HR, FBF, FMD, sPLM)
Measured: through study completion, an average of 1 year
Muscular oxygen extraction (NIRS)
Measured: through study completion, an average of 1 year
Neuromuscular functions (MCV, RFD)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura Dott. Pederzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07438002
- Sponsor's protocol ID
- 573CET
- Acronym
- TONE
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise in Patients With Chronic Kidney Disease: TONE Trial
- ClinicalTrials.gov ID
- NCT07438002
- Acronym / sponsor ID
- TONE / 573CET
- Conditions
- Chronic Kidney Disease
- Keywords
- Nephrology, exercise, physical activity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Casa di Cura Dott. PederzoliUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined exercise | Experimental | Other: Exerciseparticipants will undergo a combined endurance and resistance exercise training |
| control group | Active comparator | Other: controlparticipants performs outcome measures sessions only, including blood sample collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAll participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training | Other | combined exercise |
| controloutcome measures | Other | control group |
Primary outcome
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
Physical performance (SPPB)
Time frame: through study completion, an average of 1 year
Cardiopulmonary capacity (CPET)
Time frame: through study completion, an average of 1 year
Lower limbs strength (1-RM)
Time frame: 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
Daily physical activity amount (IPAQ)
Time frame: through study completion, an average of 1 year
Quality of life (SF36)
Time frame: through study completion, an average of 1 year
6 secondary outcomes
Nutritional status (24HR, FFQ)
Time frame: through study completion, an average of 1 year
Body composition (DEXA, BIVA)
Time frame: through study completion, an average of 1 year
Psychological and psychosocial conditions (BDI, MMSE)
Time frame: 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
Muscular oxygen extraction (NIRS)
Time frame: through study completion, an average of 1 year
Neuromuscular functions (MCV, RFD)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
Peschiera del Garda, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Kidney Disease, run by Casa di Cura Dott. Pederzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (6MWT) (time frame: through study completion, an average of 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.