NCT07438002

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 2, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

February 13, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Nephrologyexercisephysical activity

Outcome Measures

Primary Outcomes (7)

  • 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

    through study completion, an average of 1 year

  • Physical performance (SPPB)

    through study completion, an average of 1 year

  • Cardiopulmonary capacity (CPET)

    through study completion, an average of 1 year

  • Lower limbs strength (1-RM)

    through study completion, an average of 1 year

  • Maximum isometric strength of the upper limb (hand grip)

    through study completion, an average of 1 year

  • Daily physical activity amount (IPAQ)

    through study completion, an average of 1 year

  • Quality of life (SF36)

    through study completion, an average of 1 year

Secondary Outcomes (6)

  • Nutritional status (24HR, FFQ)

    through study completion, an average of 1 year

  • Body composition (DEXA, BIVA)

    through study completion, an average of 1 year

  • Psychological and psychosocial conditions (BDI, MMSE)

    through study completion, an average of 1 year

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

    through study completion, an average of 1 year

  • Muscular oxygen extraction (NIRS)

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Other Outcomes (2)

  • effect of physical activity on mitochondrial activity

    through study completion, an average of 1 year

  • Effect of physical activity on mitochondrial activity

    through study completion, an average of 1 year

Study Arms (2)

combined exercise

EXPERIMENTAL

participants will undergo a combined endurance and resistance exercise training

Other: Exercise

control group

ACTIVE COMPARATOR

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

Other: control

Interventions

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

combined exercise
controlOTHER

outcome measures

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Peschiera del Garda, Verona, 37019, Italy

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

February 27, 2026

Study Start

September 2, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations