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Recruiting NCT07438002

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

No phase Interventional Chronic Kidney Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise, control.
Who it may be relevant to
Registry conditions: Chronic Kidney Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Other Exercise
    All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training
  • Other control
    outcome measures

Primary outcome measures

  • Gait speed (6MWT) [Time frame: through study completion, an average of 1 year]
  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Italy · 1 center
  • Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda

Identifiers

NCT: NCT07438002 · 573CET

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗