ClinicalTrials.gg
RecruitingNCT07438002TONEUpdated Feb 27, 2026

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

An interventional study of Exercise and control in Chronic Kidney Disease, sponsored by Casa di Cura Dott. Pederzoli. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Casa di Cura Dott. Pederzoli · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Sep 2025, registered Feb 2026).
  • Started Sep 2025; still recruiting 1 year 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • Nephrology
  • exercise
  • physical activity
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 50 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Casa di Cura Dott. Pederzoli is the lead sponsor of 15 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signature of the
  • Patients with CKD stage 1 to 5 under conservative treatment
  • Patients undergoing chronic hemodialysis for at least 3 months
  • Age ≥ 18

Exclusion criteria

Exclusion Criteria:

  • Severe cardiovascular disease ( class IV or hypertension class III)
  • or myocardial ischemia within the last three months
  • Anatomical limitations
  • Health conditions detected during the stress test (CPET)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    combined exercise

    participants will undergo a combined endurance and resistance exercise training

    Other: Exercise

  • Active comparator
    control group

    participants performs outcome measures sessions only, including blood sample collection.

    Other: control

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

  2. Physical performance (SPPB)

    Time frame: through study completion, an average of 1 year

  3. Cardiopulmonary capacity (CPET)

    Time frame: through study completion, an average of 1 year

  4. Lower limbs strength (1-RM)

    Time frame: through study completion, an average of 1 year

  5. Maximum isometric strength of the upper limb (hand grip)

    Time frame: through study completion, an average of 1 year

  6. Daily physical activity amount (IPAQ)

    Time frame: through study completion, an average of 1 year

  7. Quality of life (SF36)

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Nutritional status (24HR, FFQ)

    Time frame: through study completion, an average of 1 year

  2. Body composition (DEXA, BIVA)

    Time frame: through study completion, an average of 1 year

  3. Psychological and psychosocial conditions (BDI, MMSE)

    Time frame: through study completion, an average of 1 year

  4. Hemodynamic and vascular functions (SV, CO, HR, FBF, FMD, sPLM)

    Time frame: through study completion, an average of 1 year

  5. Muscular oxygen extraction (NIRS)

    Time frame: through study completion, an average of 1 year

  6. Neuromuscular functions (MCV, RFD)

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. effect of physical activity on mitochondrial activity

    Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, MOTS-c (mg)

    Time frame: through study completion, an average of 1 year

  2. Effect of physical activity on mitochondrial activity

    Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, humanin (mg)

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 12 months is below that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2026
First posted
Feb 27, 2026
StartActual
Sep 2, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2026
Last update
Feb 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07438002
Lead sponsor
Casa di Cura Dott. Pederzoli
Responsible party
Sponsor
First posted
Feb 27, 2026
Start date
Sep 2, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Feb 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion