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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

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

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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)
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
    Peschiera del Garda, Verona 37019, Italy
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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