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NCT Number: NCT07438002

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

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

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Key information

Conditions

Chronic Kidney Disease Behavior Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ospedale P. Pederzoli Casa di Cura Privata S.p.A.

Peschiera del Garda, Verona, 37019, Italy

Location status: Recruiting

Location contact

Yuri Battaglia, MD

CONTACT

[email protected]

+39 0456444193

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Other

All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training

Control

Other

outcome measures

Primary outcomes

  1. 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

  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

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

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

  2. Effect of physical activity on mitochondrial activity

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

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

Sponsors and collaborators

Lead sponsor

Casa di Cura Dott. Pederzoli

Other

Registry information

Official study title

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

Acronym: TONE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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